Publications by authors named "Massimo Milani"

72 Publications

Assessment of clinical efficacy of lidocaine/tetracaine 7%/7% peel cream in fractional microablative laser procedure-associated pain for facial skin aging treatment. A randomized, controlled, single-blind trial.

J Cosmet Dermatol 2021 Jun 15. Epub 2021 Jun 15.

R&D Cantabria Labs Difa Cooper, Caronno Pertusella, Italy.

Background: Lidocaine/tetracaine 7%/7% peel cream (L/T-pC) is very effective in reducing pain in several dermatological procedures, such as hair or tattoo laser removal or conventional photodynamic therapy associated pain. Fractional laser resurfacing (FLR) is an effective treatment strategy for facial skin aging. The main drawback of FLR is the procedure-associated pain. So far, no controlled data are available regarding the efficacy of L/T-pC in reducing pain during a full-facial microablative FLR session in subjects with facial skin aging.

Aim: To assess the clinical efficacy of L/T-pC in reducing pain during microablative FLR treatment in subjects with facial skin aging. We conducted a prospective, randomized, parallel-group, controlled, single-blind trial, performed in out-patients attending to a Laser Clinic for facial skin aging treatment.

Subjects And Methods: A total of 30 subjects (4 men, 26 women; mean age 42 ± 10 years; range 28-57) with mild to moderate facial skin aging (Glogau score ≥2), suitable for FLR treatment, were enrolled after their written informed consent. Participants were randomized to L/T-pC application (45 min before the laser treatment with the removal of the cream just before the starting of laser session) (n = 20) or to control (emollient cream; n = 10). FLR was performing using a fractional microablative CO laser (Smartxide DOT 2 Deka) using a pulse power of 18 W (range 15-20) and pulse duration of 1.5 msec. The primary endpoint was the comparison of the mean visual analogue score (VAS) values between the two groups using a 10-cm scale (0 = no pain; 10: the most severe pain). The VAS score was measured just after the FLR session. Effective anesthesia (percentage of subjects with a VAS score ≤3) and the assessment of local tolerability and safety of the peel cream were the secondary trial endpoints.

Results: All the enrolled subjects concluded the trial. In the L/T-pC group, the VAS mean score was 3.0 ± 1.2. In the control group, the VAS mean score was 8.6 ± 0.5, representing a 65% reduction of the VAS score in the active treated group vs. controls. The difference between the two groups was statistically significant (p = 0.0001; Mann-Whitney test) with an absolute difference of -5 ± 0.4 cm; 95%CI of the difference: from -4.6 to -6.4 cm). Adequate anesthesia (VAS score≤3) was reported in 80% of subjects in the active group vs. 0% in the control arm. The cream was very well tolerated. One subject in the active group manifested moderate/severe edema in the cream application area, subsiding in 6 h. No other side effects were reported.

Conclusion: The application of L/T pC 7%/7% peel cream before a fractional laser resurfacing session significantly reduced the procedure-associated pain with good tolerability and safety profile.
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http://dx.doi.org/10.1111/jocd.14296DOI Listing
June 2021

Efficacy of a Topical Product Containing Purified Omental Lipids and Three Anti-Itching Compounds in the Treatment of Chronic Pruritus/Prurigo Nodularis in Elderly Subjects: A Prospective, Assessor-Blinded, 4-Week Trial with Transepidermal Water Loss and Optical Coherence Tomography Assessments.

Clin Cosmet Investig Dermatol 2020 30;13:1051-1058. Epub 2020 Dec 30.

Medical Department, Cantabria Labs Difa Cooper, Caronno Pertusella, VA, Italy.

Purpose: To investigate the efficacy of a cream containing purified omental lipids 10% and three anti-itching substances (polidocanol/stimutex/palmitoylethanolamine) in elderly subjects with chronic pruritus/prurigo nodularis (CP/CPN).

Patients And Methods: Thirty-five subjects (6 men; mean age 67±4 years) with CP/CPN were enrolled in a prospective, assessor-blinded, 4-week study. The cream was applied twice daily in the most affected body area. The primary endpoints were the evolution of the 10-cm visual analogue itch severity scale (VAS) and the 4-point verbal itching rating scale (VRS) (from 0 to 3). Secondary endpoints were the evolution of optical coherence tomography (OTC) of four skin parameters (acanthosis/hyperkeratosis/scale/dermal vascular pattern), assessed in a target lesioned area, and the transepidermal water loss (TEWL). Study endpoints were evaluated at baseline and after 2 and 4 weeks by an investigator unaware of the type of treatment.

Results: All the enrolled subjects concluded the trial. At baseline, the mean±SD scores for VAS and VRS were 4.9±2.2 and 1.7±0.7, respectively. The treatment was associated with a significant reduction (p=0.0001) of VAS score of 60% at week 2 and of 86% at week 4. VRS score was significantly reduced by 49% after 2 weeks and by 81% after 4 weeks, in comparison with baseline. TEWL (expressed as g/m2/h) mean values were 18±5.4 at baseline and 12.7±4.4 at week 2 and 9.8±4.7 at week 4 (P=0.0001 vs baseline). All the OCT parameters evaluated improved during active treatment; acanthosis grade was 0.22 mm at baseline, 0.19 mm at week 2 and 0.17 mm at week 4 (p=0.0005), representing a 23% reduction in comparison with baseline. The product was very well tolerated.

Conclusion: This purified omental lipid with three anti-itching components cream reduces significantly itch intensity in subjects with chronic pruritus/prurigo nodularis, improving the skin barrier function and skin structure.

Trial Number: ISRCTN869561669.
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http://dx.doi.org/10.2147/CCID.S292636DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7779310PMC
December 2020

Efficacy and tolerability of short contact therapy with tretinoin, clindamycin, and glycolic acid gel in acne: A randomized, controlled, assessor-blinded two-center trial: The MASCOTTE study.

Dermatol Ther 2021 01 6;34(1):e14724. Epub 2021 Jan 6.

Section of Dermatology, Department of Medicine and Surgery, University of Parma, Parma, Italy.

Retinoids and antibiotics topical treatments are commonly used as first line therapy in mild to moderate acne. However, irritant contact dermatitis is a common side effect of topical retinoids. A strategy to increase local tolerability is the "short contact therapy" (SCT) approach, consisting in the application of the product with the complete removal after 30 to 60 minutes using a non-aggressive cleanser. A gel containing tretinoin 0.02%, clindamycin 0.8%, and glycolic acid 4% in polyvinyl alcohol (MP-gel) has shown to be effective as monotherapy in mild to moderate acne with a tolerability profile similar to other topical retinoids. So far, no trials have been performed with this gel comparing the tolerability profile of SCT with standard application therapy (SAT). We conducted a 2-center randomized parallel groups, controlled, assessor-blinded study, comparing MP-gel applied as SCT in comparison with MP-gel used as SAT (The "MASCOTTE" trial). Forty-six subjects (nine men and 37 women, mean age 23 ± 4 years, range 18-31 years) with mild-to-moderate acne were enrolled, after their written informed consent in a randomized, parallel groups controlled, assessor-blinded 8-week trial. Twenty-three were assigned to MP-gel once daily (evening application) using the SCT approach (ie, complete removal of product after 1 hour using a gentle cleanser), and 23 were randomized to the SAT approach with the same gel. The primary endpoint was the evolution of the tolerability score (TS) assessed evaluating four items: erythema, dryness, stinging, and burning, using a 4-point score scale (from 0: no symptom to 3: severe symptom). Secondary endpoints were the evolution of global acne grading system (GAGS) score (range: from 0 to >39) and the investigator global assessment (IGA of acne severity) score (range from 0 to 4). TS was evaluated at 2, 4, and 8 weeks. GAGS and IGA scores were evaluated at baseline and at week eight. At week eight, an efficacy global score (EGS) (from 1: no efficacy to 4: very good efficacy) and a tolerability global score (TGS) (from 1: very low tolerability to 3: very good tolerability) evaluation were also done. All the evaluations were performed by an investigator unaware of treatment groups allocation (SCT or SAT). Thirty-eight subjects (83%) completed the 8-week treatment period. Eight subjects (two in the SCT group and six in the SAT group) dropped out prematurely due to low skin tolerability. In the SCT the TS at week two was 1.3 ± 1.7, in the SAT group TS was significantly higher (3.1 ± 1.7) (P = .028). TS was significantly lower in SCT group vs SAT also at weeks four and eight (P = .01; ANOVA test). The GAGS score at baseline was 19 ± 7 in the SCT group and 23 ± 4 in the SAT group (NS). At week 8 the GAGS score in SCT was significantly reduced to 8.5 ± 2.8 (-55%) (P = .001 vs baseline) and was also significantly lower in comparison with SAT group (8.5 vs 15; P = .0054). The IGA scores at baseline were 1.9 ± 0.6 in SCT and 2.4 ± 0.7 in SAT group. At week eight, in comparison with baseline values IGA score was reduced significantly by 48% in SCT and by 30% in SAT. EGS and TGS were significantly higher (better clinical efficacy and better tolerability) in SCT in comparison with SAT (3.6 ± 0.5 and 2.9 ± 0.3 vs 2.7 ± 0.6 and 1.5 ± 0.7; respectively). This tretinoin, clindamycin, glycolic acid gel, applied as SCT, has shown a better skin tolerability and at least a comparable clinical efficacy in comparison with the standard application modality in the treatment of mild-to-moderate acne. The SCT therefore could be an effective treatment strategy which could improve subjects' compliance and adherence.
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http://dx.doi.org/10.1111/dth.14724DOI Listing
January 2021

Inter-observer evaluation of erythema-directed photography for the assessment of erythema and telangiectasias in rosacea.

Skin Res Technol 2021 Jul 3;27(4):521-525. Epub 2020 Nov 3.

Dermatology Clinic, University of Catania, Catania, Italy.

Background: Persistent centrofacial erythema associated with telangiectasias is one of the most common phenotypes of rosacea in clinical practice, and the assessment of each component is crucial as each of them may require a different approach. The aim of this study was to evaluate the inter-observer reliability of standard photography vs erythema-directed photography for the assessment of erythema and telangiectasias in rosacea.

Materials And Methods: One hundred full-face images of 50 rosacea patients (50 standard photographs and 50 erythema-directed digital photographs) were evaluated by 8 independent experienced dermatologists using a 5-item score for erythema and telangiectasias, respectively. Inter-rater reliability, by comparing erythema and telangiectasias scores and calculating the percentage of agreement between evaluators, was assessed and the strength of agreement using the Cohen's Kappa values (95% CI) was calculated.

Results: Poor and fair strength of agreement for erythema and telangiectasias using standard photography vs moderate and good strength of agreement using erythema-directed digital photography was found.

Conclusion: Erythema-directed digital photography may provide a better strength of agreement and higher reliability among independent observers compared to standard photography in the assessment of erythema and telangiectasias in rosacea, thus suggesting new horizons for digital appraisal of skin diseases.
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http://dx.doi.org/10.1111/srt.12979DOI Listing
July 2021

Efficacy and tolerability of a cream containing modified glutathione (GSH-C4), beta-Glycyrrhetic, and azelaic acids in mild-to-moderate rosacea: A pilot, assessor-blinded, VISIA and ANTERA 3-D analysis, two-center study (The "Rosazel" Trial).

J Cosmet Dermatol 2021 Apr 21;20(4):1197-1203. Epub 2020 Sep 21.

Dermatology Clinic, University of Catania, Catania, Italy.

Background: Rosacea is a very common, chronic inflammatory disease characterized by flushing, erythema and inflammatory lesions. Increased oxidative stress plays a relevant pathogenetic role in Rosacea. Intracellular Glutathione (GSH) is the main scavenger protective mechanism against increased oxidative stress. An altered GSH metabolism in Rosacea has been described. GSH-C4 is a modified GSH molecule characterized by a better intracellular bioavailability and longer half-life. A daily cream (E-AR) containing GSH-C4 (0.1%) with beta-Glycyrrhetic (0.5%) and azelaic acids (10%), with an SPF of 30, is available.

Aim: In a pilot, prospective, two-center, assessor-blinded study we evaluate the efficacy and the tolerability of E-AR cream in subjects with mild to moderate Rosacea treated for 8 weeks.

Patients And Methods: The main outcomes were the Investigator Global Assessment (IGA) 7-point score (from 0, completely clear; to 6, severe) and the clinical and instrumental erythema severity score (ESS) (from 0 to 4) evaluated in a blinded fashion (randomly coded photographs) at baseline, after 4 (only clinical) and 8 weeks (clinical and instrumental). VISIA evaluation for erythema and lesion counts and ANTERA 3D analysis for skin haemoglobin concentration (a parameter associated with inflammation) were also performed at the same time points. Analysis of primary outcomes was performed on an intention-to-treat basis. Tolerability was evaluated at week 4 and 8 recording spontaneously reported side effects.

Results: Thirty subjects (22 women and 8 men; mean age 38 years) were enrolled after their written informed consent. Twenty-six (87%) subjects completed the study phases. Four subjects stopped prematurely the trial due to low skin tolerability (n=3) or lost to follow-up (n=1). At baseline, mean (SD) IGA score was 2.6 (0.9). At week 4, IGA score decreased (NS) to 2.3 (1.2). IGA score decreased significantly (p=0.0001) at week 8 to 1.2 (1) (mean difference 1.3; 95% CI of the difference from 0.9 to 1.7) in comparison with the baseline. The inflammatory mean (SD) lesion count, evaluated clinically, were 5.1(2.5) at baseline, 2.8 (1.9) at week 4, and 1.9 (1.7) at week 8 (P=0.0001; ANOVA Test), representing a 63% reduction. This reduction was confirmed by inflammatory lesions count performed on VISIA pictures (from 4.5 at baseline to 1.7 lesions at week 8). Similar evolution was observed for the clinical and instrumental ESS with a reduction of 56% (clinical) and 48% (VISIA), respectively, at week 8 in comparison with the baseline. ANTERA 3D photographs confirmed the positive evolution observed clinically with a significant reduction (-24%) in hemoglobin content: from 1.88 at baseline to 1.44 at week 8.

Conclusion: This new GSH-C4, beta-glycyrrethic and azelaic acids cream has shown to be efficacious in mild to moderate rosacea subjects. Local tolerability is in line with other anti-rosacea treatments.
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http://dx.doi.org/10.1111/jocd.13707DOI Listing
April 2021

Efficacy and safety of a new topical gel formulation containing retinol encapsulated in glycospheres and hydroxypinacolone retinoate, an antimicrobial peptide, salicylic acid, glycolic acid and niacinamide for the treatment of mild acne: preliminary results of a 2-month prospective study.

G Ital Dermatol Venereol 2020 Oct 1;155(5):676-679. Epub 2020 Sep 1.

Unit of Dermatology, Department of Clinical Medicine and Surgery, Federico II University, Naples, Italy.

Background: Acne vulgaris is a common and chronic skin disease that impacts on physical and psychological perceptions. Combination therapy with topical retinoids and antimicrobial agent is considered the preferred approach for most of the subjects affected by mild-to-moderate acne. A correct therapeutic management should include a prolonged treatment to ensure therapeutic success and to prevent recurrences. The aim of this study was to evaluate the efficacy and tolerability of a new topical gel formulation that combines retinol encapsulated in glycospheres and hydroxypinacolone retinoate, associated with an anti-microbial peptide (BIOPEP-15) salicylic acid, glycolic acid, and niacinamide as monotherapy in mild acne vulgaris.

Methods: A 2-month prospective study was conducted at the Unit of Dermatology of the Federico II University. Twenty-five patients aged from 14 to 30 years with mild acne of the face (GAGS score ≤ 18) were consecutively enrolled. Each patient was asked to apply the gel formulation once daily in the evening for 8 weeks. The number of acne lesions with VISIA camera system, the global acne grading system (GAGS) score, trans epidermal water loss (TEWL), skin colorimetry (X-rite Spectrocolorimeter), reflectance confocal microscopy exam were evaluated at baseline, after 4 and 8 weeks of treatment for each patient. Tolerability and safety of the product were also evaluated.

Results: Twenty-five female patients with a median age of 23.4 were enrolled. Twenty-two (88%) completed the 2-month treatment period visits. At baseline the total acne lesion number, mean (SD), was 5.5 (4) and the GAG score 9 (4). A significant (P=0.001) reduction in number of total acne lesions was observed at week 4 (-57%) and at week 8 (-80%). All patients presented a significant reduction of the GAGS score values: -42% at week 4 and -78% at week 8, confirming the clinical efficacy of the product. At baseline TEWL was 10.2 g/m2/h (1.3) and 10.7 (1.4) at week 8, thus showing that the gel did not impair the skin barrier function. Skin colorimetry was significantly (P=0.0015) reduced by the treatment in comparison with baseline (62 vs. 58). Efficacy of the gel formulation was also confirmed with RCM exams, showing a reduction of dermal inflammation and exocytosis, and an improvement of infundibular hyperkeratinization. We observed that adherence to treatment correlated positively with the improvement of the single parameters. Moreover, side effects such as erythema, dryness, and excessive xerosis were not reported, resulting in a complete adherence to the treatment.

Conclusions: Our findings provide favorable evidences of the efficacy and safety of this new product as a first line treatment in patients with mild acne, or, as a maintenance therapy for prolonged periods after the suspension of a systemic treatment. Furthermore, the tolerability of this topical product and the absence of any side effects increased the adherence to the therapy.
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http://dx.doi.org/10.23736/S0392-0488.20.06581-5DOI Listing
October 2020

Propylene glycol free 5% minoxidil lotion formulation: cosmetic acceptability, local tolerability, clinical efficacy and in-vitro skin absorption evaluations.

G Ital Dermatol Venereol 2020 Jun;155(3):341-345

Cantabria Labs Difa Cooper, Caronno Pertusella, Varese, Italy -

Background: A new propylene glycol (PG)-free 5% minoxidil (Mnx) lotion has been recently commercialized. Aim of this study was to evaluate the acceptability/tolerability and clinical efficacy of 3-month application of this new PG-free Mnx lotion and the penetration of the active compound in a reconstructed human epidermis (RHE/Episkin) model in comparison with a PG Mnx 5% lotion.

Methods: Thirty subjects of both sex with a diagnosis of AGA were enrolled in the trial. Cosmetic acceptability and clinical efficacy were evaluated after 4, 8 and 12 weeks of treatment. Global tolerability was evaluated at week 12. Cosmetic acceptability evaluation was assessed using a 7-item questionnaire using a 10-point scale score. Global Tolerability was evaluated with a 4-grade scale. Clinical efficacy was evaluated with a 5-grade scale. Skin absorption of PG-free Mnx was evaluated and compared with a PG Mnx solution using the Episkin model.

Results: All subjects concluded the study. The 7-item questionnaire mean values were always <2 at each time-point evaluation, demonstrating high cosmetic acceptability/tolerability. No subjects reported burning, itching or redness sensations. Global Tolerability score mean±SD value was 1.7±0.4. Clinical efficacy scores were 0.4, 0.6 and 1.2 at week 4, 8 and 12, respectively. PG-free Mnx showed similar amount of absorbed dose in comparison with PG Mnx.

Conclusions: This new PG-free lotion shows a very good cosmetic acceptability/tolerability profile. Clinical efficacy was also documented. The skin penetration of this formulation is comparable to the PG Mnx lotion, supporting the bioequivalence of the two products.
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http://dx.doi.org/10.23736/S0392-0488.20.06554-2DOI Listing
June 2020

Efficacy of lidocaine 7 %, tetracaine 7 % self-occlusive cream in reducing MAL-cPDT-associated pain in subjects with actinic keratosis: A randomized, single-blind, vehicle-controlled trial (The "3P-Trial").

Photodiagnosis Photodyn Ther 2020 Jun 12;30:101758. Epub 2020 Apr 12.

Dermatology Medica Plus, Modena, Italy.

Introduction: Conventional photodynamic therapy (cPDT) is considered a very effective treatment of actinic keratosis (AK) lesions. However, its use is limited by the fact that this procedure could be very painful. The use of topical anesthetics such as tetracaine or lignocaine/prilocaine has shown disappointing results in term of pain reduction. A self-occlusive topical 7% lidocaine/7% tetracaine anesthetic cream (LT-C) approved by the FDA to provide local topical anesthesia in adults undergoing superficial dermatological procedures is available. There are no data regarding its pain reducing effect during cPDT. We perform a prospective, randomized, single-blind, two-center trial (The 3P-Trial) to assess the pain reduction effect of LT-C versus vehicle in subjects with AK undergoing cPDT.

Material And Methods: Fifty AK subjects (74 ± 10 years, 32 men, 18 women) with on average 17 lesions were enrolled after their written informed consent. Eight subjects presented also a total of 16 basal cell carcinoma lesions. Twenty-five were randomized to LT-cream, applied 1 h before the Methyl amino levulinate (MAL)-cPDT session and 25 to cream vehicle. The main outcome was the patient-assessed evaluation of pain score during and just after the conclusion of cPDT session (mean of the two values) using a 10-point visual analog scale (VAS). The cPDT session (LED Red light 630 nm) was performed with a duration of 6 ± 2 min with a standard fluence of 37 J/cm2. All treated lesions were prepared by gentle superficial curettage.

Results: All the randomized subjects concluded the trial. The mean ± SD of VAS score in vehicle group was 6.2 ± 2.7 (95 % CI of the mean: 5.0-7.5). In the group treated with LT-cream the VAS score was 3.3 ± 1.9 (95 % CI of the mean: 2.5-4.1). The active cream reduced the VAS score by 47 %. Median values of pain VAS score in the active group was reduced by 60 % in comparison with vehicle group (3.0 vs 7.5). The difference between the two groups was statistically significant (p = 0.0009; Mann-Whitney test).

Discussion: The 3P-trial has demonstrated that the preventive application of the self-occlusive lidocaine 7%-tetracaine 7% cream is very effective in reducing the procedure-associated pain during MAL-cPDT for the treatment of AK lesions.
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http://dx.doi.org/10.1016/j.pdpdt.2020.101758DOI Listing
June 2020

Efficacy and Tolerability of Topical Polyphenon E in Multiple "Seborrheic Keratosis-Like" Lesions of the Groin in an Immunocompetent 26-Year-Old Man.

Case Rep Dermatol 2019 Sep-Dec;11(3):310-316. Epub 2019 Nov 7.

Medical Department Cantabria Labs Difa Cooper, Caronno Pertusella, Italy.

Polyphenon E 10%, a green tea extract containing epigallocatechin gallate (EGCG) as the main active compound, is a topical formulation indicated for the treatment of genital warts. Polyphenon E has also shown to be very effective in the treatment of periungual and plane warts. Here, we report a dramatic clinical effect of topical treatment with polyphenon E in a subject with multiple "seborrheic keratosis-like" lesions of the genital area. An immunocompetent 26-year-old Caucasian man came to our attention in October 2018. The subject, a regular blood donor, presented several (more than 100) light brown dome-shaped papular lesions in the groin area and in the penile shaft. A clinical diagnosis of Bowenoid papulosis-like multiple condylomata of the groin was made. A 2-month imiquimod treatment did not induce any relevant improvement in terms of volume and number of lesions. A treatment with Polyphenon E, a topical green tea extract with 10% of EGCG (Veregen®), was therefore started. After 2 months of Polyphenon E treatment, a dramatic reduction of the majority of the lesions was observed. After 3 months of treatment, all the lesions disappeared with only hyperchromic residues. Histological and immunohistological findings supported seborrheic keratosis as the conclusive diagnosis. This case report suggests that topical green tea extract could be very effective in the treatment of "seborrheic keratosis-like" lesions of the inguinal area.
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http://dx.doi.org/10.1159/000503989DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6902246PMC
November 2019

Treatment of brittle nail with a hydroxypropyl chitosan-based lacquer, alone or in combination with oral biotin: A randomized, assessor-blinded trial.

Dermatol Ther 2019 09 31;32(5):e13028. Epub 2019 Jul 31.

Medical Department, Cantabria Labs Difa Cooper, Caronno Pertusella, Italy.

We evaluated in a randomized, assessor-blinded, study the efficacy of a hydroxypropyl chitosan-based nail lacquer (HPC-NL) alone or in combination with oral biotin (HPC-NL + B) in the treatment of brittle nail syndrome (BNS). Fifty subjects (21 men; mean age 64 years) with BNS were enrolled. Twenty-six were randomly assigned to HPC-NL and 24 to the HPC-NL and biotin, 10 mg/daily (+B). Topical and oral treatments lasted for 4 consecutive months. The primary outcome was the evolution of the Onychodystrophy Global Severity Score (OGSS) assessing nail dystrophy, lamellar and longitudinal splitting, dyschromia, and pitting. At baseline, the OGSS, mean (SD), was 8.4 (2.1) in the HPC-NL group and 11.8 (2.3) in the HPC-NL + B group. The OGSS was significantly reduced during treatments in both groups. At Month 4, OGSS was reduced by 57% (HPC-NL) and 62% (HPC-NL + B). At the end of study period, the percentage of subjects with an OGSS reduction of ≥50% in comparison with baseline was 53% in the HPC-NL group and 80% in the HPC-NL + B group (p = .05). Both treatments were well tolerated. In subjects with BNS, HPC-NL alone is associated with a clinically relevant improvement of nail appearance. The combination of HPC-NL and oral biotin is associated with further clinical improvement.
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http://dx.doi.org/10.1111/dth.13028DOI Listing
September 2019

Skin protective effects of an antipollution, antioxidant serum containing extract, ferulic acid and vitamin C: a controlled single-blind, prospective trial in women living in urbanized, high air pollution area.

Clin Cosmet Investig Dermatol 2019 29;12:393-399. Epub 2019 May 29.

Eurofins Cosmetics & Personal Care, Italy.

Air pollution causes skin damage and favors skin aging processes such as dark spots and wrinkles, through oxidative stress. Pollutant substances accelerate skin aging through a specific activation of intracellular receptors called AhR (aryl-hydrocarbon receptors). aqueous extract (DAE) has shown to counteract the pollutant-induced AhR activation. Ferulic acid (FA) and vitamin C (VC) are potent antioxidant substances. A serum containing DAE/FA/VC has been recently developed. So far, no clinical data are available regarding the protective actions of this serum against the detrimental effects of air pollution on the skin. We conducted a prospective, single-blind, 28-day study to assess efficacy and protective effects against air pollution skin damage of a new serum containing extract. Twenty, photo type I-III, women (mean age 42 years) with at least three dark spots on the face, living in a homogenous urbanized, high pollution area (Rome) were evaluated. The objectives of the study were to evaluate the effects of treatment on skin barrier function, assessed by transepidermal water loss (TEWL) measurement (Tewameter), the effect on dark spots, evaluated by means of colorimetry (Colorimeter CL 400), and the effect on squalene peroxide (SQOOH)/squalene (SQ) skin ratio assessed with face swabs. The trial was conducted between November 20 and December 19, 2018. In comparison with baseline, the product induced a significant improvement of skin hydration (-19% of TEWL), a significant improvement of dark spots (+7%) and a significant improvement of SQOOH/SQ ratio (-16%). The product was evaluated very well by >90% of the treated subjects regarding cosmetic acceptability. A serum containing DAE/FA/VC has shown to improve skin barrier function, to reduce dark spots and to counteract the skin oxidative stress in women living in high pollution urban area.
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http://dx.doi.org/10.2147/CCID.S204905DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6549792PMC
May 2019

Effects of a cream containing 5% hyaluronic acid mixed with a bacterial-wall-derived glycoprotein, glycyrretinic acid, piroctone olamine and climbazole on signs, symptoms and skin bacterial microbiota in subjects with seborrheic dermatitis of the face.

Clin Cosmet Investig Dermatol 2019 2;12:285-293. Epub 2019 May 2.

Dermatology Clinic, Ospedale Centrale di Bolzano (BZ), Bolzano, BZ, Italy.

A new cream formulation containing hyaluronic acid 5%, complexed with a mix of a bacterial-wall-derived glycoprotein and peptide glycan complex (EDS), has been recently developed. We evaluated in a prospective, assessor-blinded, 6-week study the efficacy and tolerability of EDS in the treatment of facial seborrheic dermatitis (SD) and the effects on skin microbiota. Seventy-five subjects (mean age 46; 60 men) with moderate-severe SD of the face were enrolled. EDS cream was applied twice daily. The primary outcome was the evolution of the Investigator Global Assessment (IGA) score, evaluating erythema, scale/flaking, grade of seborrhea and itch. Superficial skin bacterial microbiome at baseline and after treatment was assessed, using the 16S rRNA gene methodology, in affected and non-affected face areas. Local tolerability was evaluated checking self-reported side effects at each visit. Baseline IGA scores (mean±SD) was 10±3. The use of EDS reduced IGA score significantly by 70% at week 3 and by 88% at week 6. An increase in the abundance of genera associated with a significant drop of genera presence was detected in affected areas. The ratio of relative abundance of genera Cutibacterium increased significantly after treatment in affected areas. The product was very well tolerated. Treatment with EDS applied twice daily for 6 consecutive weeks was associated with a reduction of the signs and symptoms of SD. Furthermore, after EDS cream treatment, a reequilibrating effect on facial skin microbiota was observed. The product was very well tolerated.
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http://dx.doi.org/10.2147/CCID.S205904DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6525831PMC
May 2019

Generalized verrucosis: A therapeutic challenge: Efficacy of topical sinecatechins (Veregen) 10.

Dermatol Ther 2019 07 5;32(4):e12986. Epub 2019 Jul 5.

Section of Dermatology, University of Parma, Parma, Italy.

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http://dx.doi.org/10.1111/dth.12986DOI Listing
July 2019

Effects of topical piroxicam and sun filters in actinic keratosis evolution and field cancerization: a two-center, assessor-blinded, clinical, confocal microscopy and dermoscopy evaluation trial.

Curr Med Res Opin 2019 10 13;35(10):1785-1792. Epub 2019 Jun 13.

Dermatology Unit, University of Campania Luigi Vanvitelli , Naples , Italy.

Actinic keratosis (AK) is considered an "in situ" non-melanoma skin cancer induced by ultraviolet chronic exposure. Sunscreen and topical anti-inflammatory agents like diclofenac could improve the evolution of this kind of lesions. A topical product containing piroxicam 0.8% and sun filters (50 SPF) (ACTX) has been shown to be very effective in reducing AK lesions. So far, no data are available regarding the effects of this product on skin modifications evaluated by reflectance confocal microscopy (RCM) and dermoscopy at the lesion sites and on the skin around the lesions (field cancerization). To evaluate in a two-center, assessor-blinded, prospective trial the effect of ACTX on AK number, RCM and dermoscopy parameter evolution of a target lesion in subjects with multiple AK lesions. A total of 54 subjects (42 men and 12 women; mean age 65 years) with AK lesions grade I-III located on the scalp ( 36) or face ( 18) were enrolled after their written informed consent. ACTX was applied twice daily on the face and scalp for six consecutive months. AK lesion count was performed at baseline and after 3 and 6 months. Lesion count was assessed in a blind fashion evaluating digital color high definition images performed at each visit and coded in a blinded fashion. RCM evaluations were performed at the same time-points. A dermoscopy evaluation was performed at baseline and after 6 months. RCM and dermoscopy were assessed on a pre-specified target lesion. The RCM severity score was used evaluating 11 items, examining stratum corneum, stratum granulosum, stratum spinous and dermal layers (maximum score 11 points). The dermoscopy score evaluated erythema, scaling and follicular plugs (from 0 to 4 for each item) and pigmentation (from 0 to 5). Forty-nine subjects (90%) concluded the trial. At baseline, the mean (SD) number of AK lesions was 9.6 (5.2). AK lesions significantly decreased to 5.9 and to 5.6 after 3 and 6 months of ACTX treatment ( .001; intention to treat analysis), representing a -42% reduction. A reduction of AK lesion numbers >50% in comparison with baseline was observed in 51% of subjects at month 6. New AK lesions appeared in five subjects (9%). The RCM mean (SD) severity score at baseline was 6.4 (2.0). ACTX treatment was associated with a progressive and significant ( .002) reduction to 4.9 after 3 months and to 4.8 (2.3) at month 6 (a -25% reduction). The dermoscopy score at baseline was 5.5 (2) and it was reduced significantly ( .007) to 4.5 (2) at the end of the study. The product was in general very well tolerated. A 6 month application of ACTX in subjects with AK lesions was associated with an improvement in AK lesion count and with a reduction in the RCM/dermoscopy severity scores of the target lesion. ISRCTN22070974.
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http://dx.doi.org/10.1080/03007995.2019.1626227DOI Listing
October 2019

Topical purified omental lipid formulations in the prevention of skin ulcers: a narrative review.

J Wound Care 2019 May;28(5):284-290

Medical Department Cantabria Labs Difa Cooper, Caronno Pertusella Italy.

The omentum is a large peritoneal fold. Its main function is to protect abdominal organs, exerting a defensive action against infective agents. The tissue promotes repair after several types of injury. An extensive vascularisation is the key characteristic of this tissue and the omentum has the highest level of production and content of vascular endothelial growth factor (VEGF). A component of omentum is the lipid compound, which carries out important activities for the organism. Omentum is rich in neutral glycerides, phospholipids, glycolipids and gangliosides. Dermatological products containing purified omental lipids are commercially available and topical omental extracts have been useful in the softening, moisturising and smoothing of skin. Animal-derived omental lipids could be use in topical products with different textures (creams, fluids, emulsions and cleansers) and at different concentrations (10-25%) for the treatment of fragile skin or skin conditions causing risk of ulcer formation. This review summarises the pharmacological rationale of purified omental lipids in topical formulations for use in fragile skin conditions, the clinical efficacy data available in the scientific literature and the potential future perspectives. Efficacy of topical purified omental lipids have been demonstrated in numerous clinical controlled trials involving a total of 320 subjects. These studies demonstrated that this product helps prevent the formation of pressure ulcers (PU) in hospitalised high-risk subjects, improves wound healing process, normalises skin hydration in diabetic subjects with moderate-severe skin xerosis and improve the clinical evolution of diabetic foot. Therefore, purified omental lipid could be an effective tool for the management of fragile skin and the skin at high risk of PU formation.
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http://dx.doi.org/10.12968/jowc.2019.28.5.284DOI Listing
May 2019

Efficacy and tolerability of 1% ciclopirox shampoo in the treatment of moderate-to-severe scalp seborrheic dermatitis: a multicenter, prospective, assessor-blinded trial.

G Ital Dermatol Venereol 2019 Jun;154(3):342-346

Difa Cooper, Caronno Pertusella, Varese, Italy -

Background: Seborrheic dermatitis (SD) is a very common inflammatory skin disease. It occurs in 1-3% of the population. The most supported pathogenetic theory links SD to dandruff via a common etiology, yeasts of the genus Malassezia. Ketoconazole and ciclopirox (CPX) shampoo are considered as the first line treatment of SD of the scalp. CPX is a broad-spectrum, hydroxypyridone-derived, synthetic antifungal agent with anti-bacterial, anti-inflammatory, and anti-oxidant properties. The aim of this study was to assess the efficacy and tolerability of 1% CPX shampoo in SD of the scalp.

Methods: A total of 40 patients, 31 men and 9 women, mean age 33±6 years, with scalp SD of moderate-to-severe grade were enrolled, after their informed consent, in this 12-week prospective assessor-blinded trial. One-percent CPX shampoo (5 mL) was applied twice a week for 12 weeks. The primary efficacy parameter was the Total Dandruff Severity Score (TDSS), based on 4-point ordinal scales describing signs and symptoms (scaling, inflammation, and itching) of the disease, evaluated in an assessor-blinded fashion, at baseline and after 6 and 12 weeks. Secondary outcomes were the single items of the TDSS and the evaluation of local tolerability.

Results: At baseline the TDSS was 17±5. After 1% CPX TDSS was reduced to 10±5 at week 6 and to 6.6±4 at the end of study period (P=0.0001; ANOVA test). This difference represents a 62% reduction in comparison with baseline. At week 12, the reduction of scaling, inflammation and itching scores were -55%, -65%, and -69%, respectively. The product was very well tolerated. No side effects were reported or observed during the study.

Conclusions: The study supports the use of 1% CPX shampoo in the treatment of SD of the scalp. CPX shampoo was able to reduce desquamation, inflammation and itching associated with scalp SD. Furthermore, 1% CPX shampoo was found to be safe and well tolerated.
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http://dx.doi.org/10.23736/S0392-0488.17.05623-1DOI Listing
June 2019

Topical sinecatechins in the treatment of verrucae planae of the face.

Dermatol Ther 2019 05 29;32(3):e12891. Epub 2019 Apr 29.

Section of Dermatology, University of Parma, Parma, Italy.

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http://dx.doi.org/10.1111/dth.12891DOI Listing
May 2019

Efficacy and Safety of Intralesional Methotrexate in the Treatment of a Large Keratoacanthoma of the Dorsal Hand in a 99-Year-Old Woman.

Case Rep Dermatol 2018 Sep-Dec;10(3):247-250. Epub 2018 Nov 14.

Medical Department, Cantabria Labs Difa Cooper, Caronno Pertusella, Italy.

Several case reports and retrospective studies have demonstrated that intralesional methotrexate (MTX) could be a very effective and safe alternative treatment of keratoacanthoma (KA). Here, we report a rapid clinical efficacy of two intralesional MTX injections (total dose 40 mg) that were performed 1 week apart in the treatment of a large KA lesion of the dorsal hand in a 99-year-old woman. The lesion, with a 3-cm major axis diameter and a thickness of 2 cm with a central ulceration had rapidly appeared on the right dorsal hand. A 3-mm punch biopsy confirmed the diagnosis of a well-differentiated KA-type spinous cellular carcinoma. Due to the presence of comorbidities (arterial hypertension and atrial fibrillation) and chronic treatment with antihypertensive and oral anticoagulant drugs, treatment with intralesional MTX was proposed to the patient. Two intralesional MTX injections of 20 mg each were performed 1 week apart. A very fast resolution of the lesion was observed after the first injection. A week after the second injection a full resolution of the skin lesion was observed, with a nearly complete resolution of the central ulceration. The treatment was very well tolerated. No local or systemic side effects were observed. This case report confirms that intralesional MTX could be considered an effective and safe treatment of KA also in very old subjects.
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http://dx.doi.org/10.1159/000494322DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6276738PMC
November 2018

Efficacy of different photoprotection strategies in preventing actinic keratosis new lesions after photodynamic therapy. The ATHENA study: a two-center, randomized, prospective, assessor-blinded pragmatic trial.

Curr Med Res Opin 2019 01 15;35(1):141-145. Epub 2018 Nov 15.

Direzione Medica Cantabria Labs Difa Cooper Caronno Pertusella (VA), Italy.

Treatment of actinic keratosis (AK) and field cancerization with photodynamic therapy (PDT) is an effective therapeutic approach with a significant reduction in the number of AK lesions (-75% or more) associated with a significant cosmetic improvement of the photodamaged skin. Recently, also, the daylight PDT (DL-PDT) has proven to be as effective as the conventional PDT (C-PDT), but with a better tolerability. After C-PDT and DL-PDT it is advised to use photoprotection strategies to improve the clinical evolution and prevent the appearance of new AK lesions that usually appear 3-6 months after the last phototherapy session. However, there are no robust clinical data regarding the type of photoprotection to be used (SPF level, duration of treatment, etc.) after successful PDT. The present study (ATHENA trial) evaluated the efficacy and tolerability of a topical product based on 0.8% piroxicam and 50+ solar filters (ACTX), applied twice a day as sequential therapy after C-PDT or DL-PDT on the evolution of AK lesions number compared to the use of very high photoprotection products commonly used in this clinical setting (SPF50+ or SPF100+ associated with photolyase) (Standard Sunscreens: SS group). This was a multicenter, randomized, two-arm, prospective controlled, assessor-masked outcome evaluation, parallel group (1:1), pragmatic study of 6 months duration in patients with multiple AK lesions suitable for photodynamic therapy. The objectives of the study were the evaluation of the evolution of the number of AK lesions during the period of treatment/application of the study products, and the Investigator global clinical assessment score (IGA score; 4: marked improvement, 3: good, 2: moderate; 1 no improvement; 0: worsening) 2, 3, and 6 months after the last PDT session. A total of 68 subjects (50 men, 18 women; mean age 70 years), 34 assigned to treatment with ACTX and 34 to treatment with SS (17 treated with a SPF50+ and 17 with a photolyase-containing SPF100+ products), were enrolled in the study. The number of AK lesions present before C-PDT/DL-PDT was 11.8 ± 5.8 in the ACTX group and 12.4 ± 6.9 in the SS group. In both groups, there was a progressive reduction of AK lesions observed at baseline (-86% and -87% after 2 months and -88% and -83% at month 3 in ACTX and in the SS group, respectively). At month 6, AK mean lesion number was 1.8 ± 1.6 in the ACTX and 3.2 ± 2.3 in the SS group; this difference was statistically significant ( = 0.03). The IGA score at the end of the study was 3.2 in the ACTX and 2.7 in the SS group ( = 0.05). The percentage of subjects with an IGA score of 4/3 (very good or good) was 81% in the ACTX and 55% in the SS group ( = 0.06). In subjects with AK treated with C-PDT or DL-PDT, a "medicalized" photoprotection treatment is associated with a favorable clinical outcome with progressive reduction of lesions. In contrast to a very high photoprotection (SPF50+ or SPF100+/photolyase), the use of piroxicam 0.8%/SPF 50+ is associated with a significantly greater improvement in clinical evolution of AK lesions.
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http://dx.doi.org/10.1080/03007995.2018.1544887DOI Listing
January 2019

Effects of topical 0.8% piroxicam and 50+ sunscreen filters on actinic keratosis in hypertensive patients treated with or without photosensitizing diuretic drugs: an observational cohort study.

Clin Cosmet Investig Dermatol 2018 12;11:485-490. Epub 2018 Oct 12.

Department of Dermatology, University of Rome "Tor Vergata", Rome, Italy.

Background: Photosensitizing diuretics use (especially thiazide compounds) is associated with a significantly higher risk of squamous cell carcinoma (SCC). Actinic keratosis (AK) is a precursor of SCC.

Study Aim: To evaluate in a prospective cohort study the efficacy of topical piroxicam 0.8% and sunscreen 50+ (ACTX) in the treatment of AK in hypertensive subjects with or without TD treatment.

Subjects And Methods: A total of 119 hypertensive subjects with multiple AK (39 under chronic TD treatment; and 80 treated with other non-TD, non-photosensitizing antihypertensive drugs) were enrolled after their informed consent in a 6-month observational cohort study. All the subjects were treated with ACTX twice daily. The primary endpoint was the evolution of AK lesions at baseline, after 3 and 6 months. The secondary endpoint was the clearance of AK target lesions and field of cancerization by dermoscopic evaluation using a score evaluating erythema, scaling, pigmentation, and follicular plugs (ESPFP score; ranging from 0 to 20). An investigator, unaware of the type of antihypertensive treatments (TD or non-TD), performed all the clinical and dermoscopy evaluations.

Results: At baseline, AK mean (SD) lesion number in TD group was 14.1(4) and 14.6(4) in the non-TD group. ESPFP mean (SD) score at baseline was 5.8(1.2) in both groups. A significant reduction of AK lesions in comparison with baseline was observed in both groups. A statistically significant greater reduction was observed in TD in comparison with the non-TD group (-54% vs -32%). ESPFP score was reduced in a higher proportion in the TD group in comparison with the non-TD group (-60% vs -37%, respectively). ACTX treatment was very well tolerated.

Conclusion: In hypertensive subjects with multiple AK, the topical use of ACTX is associated with a significant reduction of lesions count with an improvement in the field cancerization. The clinical efficacy is more pronounced in subjects under thiazide diuretics treatment.
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http://dx.doi.org/10.2147/CCID.S178386DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6188002PMC
October 2018

Effects of oral supplementation with FOS and GOS prebiotics in women with adult acne: the "S.O. Sweet" study: a proof-of-concept pilot trial.

Clin Cosmet Investig Dermatol 2018 8;11:445-449. Epub 2018 Oct 8.

Dermatology Clinic, University of Catania, Catania, Italy.

Background: We evaluated the effects of 3-month prebiotic oral supplementation with fructo-oligosaccharides (FOS) and galacto-oligosaccharides (GOS) on glucose and lipid metabolic parameters in women with adult acne (female adult acne).

Methods: Twelve women, mean age 35 years, with mild to moderate acne were enrolled. Exclusion criteria were severe acne, body mass index (BMI) >25, history of diabetes mellitus, polycystic ovary syndrome, regular intake of prebiotics or probiotics, and history of inflammatory intestinal diseases. At baseline visit (T0), at month 1 (T1), and at month 3 (T2) fasting glucose, blood insulin, glycated hemoglobin (HbA1c), C-peptide, triglycerides, total cholesterol levels, and BMI were measured. Subjects were treated with a food supplement containing FOS (100 mg) and GOS (500 mg), one sachet daily, for 3 months. Subjects were instructed to follow their regular diet, and no dietary restrictions were suggested.

Results: At baseline, the BMI, mean ± SD, was 23±0.7. No modification of BMI was observed during the study. At baseline, fasting blood glucose levels were 92±7 mg/dL. A significant (=0.02) reduction was observed at month 1 (86±5 mg/dL) and at month 3 (85±7 mg/dL) (-10%). Total cholesterol levels were reduced significantly (=0.018) from 184±19 to 161±10 mg/dL (-13%) at the end of the study. Triglycerides at baseline were 51 mg/dL and were reduced to 46 mg/dL (=0.05). Insulin and C-peptide plasma levels showed a nonsignificant reduction trend from baseline to the end of the study. In subjects with baseline insulin level >6 µUI/mL (n=6) the FOS/GOS supplementation induced a significant (=0.03) reduction from 7.8 to 4.3 µUI/mL at day 90 (-45%). C-peptide was reduced from 2.1 to 1.6 ng/mL (month 3). HbA1c at baseline was 35 mg/dL and 32 mg/dL at the end of the study (NS).

Conclusion: In adult female acne, supplementation with prebiotic FOS and GOS was associated with positive effects on glycemic and lipid metabolic parameters.
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http://dx.doi.org/10.2147/CCID.S179627DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6181472PMC
October 2018

Efficacy of sinecatechins 10% as proactive sequential therapy of external genital warts after laser CO ablative therapy: The PACT study (post-ablation immunomodulator treatment of condylomata with sinecatechins): a randomized, masked outcome assessment, multicenter trial.

Int J STD AIDS 2019 02 20;30(2):131-136. Epub 2018 Sep 20.

4 Dermatology Clinic, University of Catania, Catania, Italy.

External genital warts (EGW) are the most common viral sexually transmitted infection. Ablative treatments like cryotherapy, curettage, and CO laser therapies offer rapid onset of effect, fast clearance, and reduction of virus load. However, these procedures are associated with high recurrence rates (RRs) ranging from 20% to 77% in the short and medium terms and do not provide sustained clearance. After laser therapy removal of EGW, an RR up to 77% has been reported. Topical sinecatechins (TS) 10% is a patient-applied regimen for the treatment of EGW with a low RR (<6.5%) at three months after completion of the therapy in the pivotal trials conducted so far. Sinecatechins can be considered a suitable proactive sequential therapy (PST) after ablative strategies to obtain a low RR. So far, no prospective data are available regarding the efficacy of sinecatechins 10% as PST. We evaluated the efficacy and tolerability of TS 10% ointment applied twice daily in subjects with "difficult to treat" EGW after CO laser ablative treatment in a prospective controlled trial. A total of 87 subjects (76 men and 11 women; mean age 42 years) were enrolled in this three-month masked outcome assessment parallel group trial with imbalanced randomization allocation (2:1). One week after a successful CO laser treatment, 60 subjects were randomized to TS 10% treatment and 27 subjects to no treatment (control group: ConTRol (CTR); no sequential therapy). All patients had a history of an average of 4.5 previous ablative treatments in the last 12 months due to recurrent EGW. Mean (standard deviation) baseline number of treated lesions was 6.5 (2.7). One subject in the TS arm dropped out due to burning sensation after the application of the product. Therefore, 86 subjects completed the study. After three months, in the TS group, three subjects presented new EGW lesions (RR: 5%) on treated sites. In the CTR group, eight subjects presented new EGW lesions (RR: 29%) on treated sites (p = 0.0024; odds ratio: 0.16; 95% confidence interval: 0.04-0.68). In the TS group, 34 subjects (56%) reported mild to moderate erythema or burning sensation at the application site. In this prospective multicenter trial, the use of TS 10% as PST after ablative treatment with CO laser was associated with a lower recurrence rate of new EGW lesions in the short term in comparison with the control group. Comparative larger trials are warranted to evaluate the role of this approach as PST (Trial Registration Number: ISRCTN44037479).
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http://dx.doi.org/10.1177/0956462418797874DOI Listing
February 2019

Efficacy and Tolerability of Topical Green Tea Extract (Polyphenon E) Application in a "Therapy-Resistant" Plantar Wart.

Case Rep Dermatol 2018 May-Aug;10(2):127-132. Epub 2018 May 18.

Medical Department, Cantabria Lab, Difa Cooper, Caronno Pertusella, Italy.

Plantar warts account for 30% of all cutaneous warts. These lesions could be very painful, especially if the lesion is located over pressure sites such as the metatarsal head. Plantar wart treatment remains a challenging therapeutic problem. A 67-year-old immunocompetent nonsmoking man presented with a large mosaic plantar wart on his right foot. The lesion had been present for 5 years. Several cryotherapy sessions (a total of 6 procedures) had been performed with no success. The lesion was therefore treated with a 5-fluorouracil (5-FU) regimen and then with a topical combination of 5-FU and salicylic acid, but also these approaches failed. At the initial visit, a large (16 cm) mosaic wart lesion was present. Treatment with topical Polyphenon E, 10%, twice daily was prescribed and started. After 3 months of treatment, the lesion completely disappeared. Interestingly, no curettage or mechanical pickling of the hyperkeratotic parts of the lesion were performed before the start of the treatment. Local tolerability was evaluated as very good by the patient.
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http://dx.doi.org/10.1159/000489160DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6006655PMC
May 2018

Treatment of Grade II and III Actinic Keratosis Lesions with a Film-Forming Medical Device Containing Sunscreen/Piroxicam 0.8% and a Retinoic Acid/Glycolic Gel: A Pilot Trial.

Dermatol Ther (Heidelb) 2018 Sep 31;8(3):399-404. Epub 2018 May 31.

Dermatology Division, Sassuolo Hospital, Sassuolo, Italy.

Introduction: Lesion and field-targeted treatments of actinic keratosis (AK) are commonly indicated for grade I and II type lesions. Grade III lesions are in general more difficult to treat. A film-forming medical device containing piroxicam 0.8% and sunscreen (SPF 50+) (PS) has been shown to be effective in the treatment of grade I and II AK lesions. Topical and oral retinoids have been utilized in AK and non-melanoma skin cancers. Topical glycolic acid promotes keratolysis and stimulates collagen synthesis for repair and skin rejuvenation and could be useful in AK treatment strategies. A gel containing retinoid acid (0.02%) and glycolic acid (4%) (RC) is commercially available. The objective of the study was to evaluate the efficacy and local tolerability of a combined treatment approach with PS and RC in subjects with multiple grade II and III AK lesions.

Methods: Twenty-two subjects (16 males and 6 females; mean age 68 years) with more than five AK lesions were enrolled after obtaining their informed consent in a 3-month trial. PS cream was applied twice daily every day and RC gel was applied twice daily for 2 consecutive days every week. The primary endpoint was the evolution of the AK mean number from baseline to the end of the trial. Secondary endpoints were the thickness of the target lesion (expressed in mm) and the erythema score (hemoglobin content), evaluated using a standardized computer-based image acquisition analysis system (Anthera 3D).

Results: At baseline, the mean (SD) lesion number was 7.7 (3) for grade II and 1.4 (1) for grade III AK. At the end of the study, a significant (P = 0.001) reduction was observed for both grade II (- 81%; from 7.7 to 1.5) and grade III (- 22%) lesions. Six grade III lesions out of 31 (20%), presented at baseline, completely disappeared at month 3. For grade III lesions, a significant mean thickness reduction of 51% was observed at month 3. The erythema score (all lesions) was reduced by 70%. Four patients out of 22 (18%) were completely free of AK lesions at month 3. No severe side effects were reported.

Conclusion: In this exploratory trial, a combined treatment with a cream containing piroxicam and sunscreen and a retinoic/glycolic gel was associated with a substantial reduction of both grade II and III AK lesions with good local tolerability.

Funding: Cantabria Labs Difa Cooper.
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http://dx.doi.org/10.1007/s13555-018-0244-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6109025PMC
September 2018

The efficacy and tolerability of 5-aminolevulinic acid 5% thermosetting gel photodynamic therapy (PDT) in the treatment of mild-to-moderate acne vulgaris. A two-center, prospective assessor-blinded, proof-of-concept study.

J Cosmet Dermatol 2019 Feb 22;18(1):156-162. Epub 2018 May 22.

Dermatology, University of Rome Tor Vergata, Rome, Italy.

Background: Acne vulgaris is a chronic inflammatory skin disease, commonly treated with topical or systemic drugs, according to the severity of the condition. Retinoids and antibiotic compounds are considered cornerstone approaches in this condition. However, low adherence to the therapy and the issue of bacterial resistance undermine the efficacy in the long term. Photodynamic therapy (PDT) with 20% aminolevulinic acid (ALA) has shown to be effective in the treatment of inflammatory acne. Skin tolerability, however, could be a limiting factor for a widespread use of this approach. A new formulation of 5% ALA in thermosetting gel has been recently available. This formulation allows a more convenient application procedure without occlusion and better and more efficient release of the active compound in comparison with traditional ALA formulations like creams or ointments.

Study Aim: To evaluate in a two-center, assessor-blinded, prospective, proof-of-concept study, the efficacy, and tolerability of red-light (630 nm) PDT with a new 5-ALA "low-dose" topical gel formulation (5%) in the treatment of inflammatory mild-to-moderate acne vulgaris (AV).

Subjects And Methods: A total of 35 subjects with moderate AV of the face (mean age: 24 ± 8 years, 13 men and 22 women) were enrolled, after their written informed consent. The primary outcome was the evolution of GAG (Global Acne Grade System) score at baseline and after an average of three, 630-nm, 15-minute, PDT sessions, performed every 2 weeks. GAG score was also calculated in a follow-up visit 6 months after the last PDT session. Skin tolerability was assessed during PDT sessions with a patient-reported discomfort level evaluation score from 0 (no discomfort at all) to 3 (severe discomfort).

Results: At baseline, the GAG score was 21 ± 6. After the last PDT session, the GAG score evaluated in a blinded fashion (digital photographs) was significantly reduced to 6.5 ± 5.7, representing a 70% reduction (P = .0001, Wilcoxon test; mean difference 14.9; 95% CI of the difference: 12.1-17.6). At the follow-up visit, the GAG score was 6.7 ± 6.8. The 5% ALA thermosetting gel Red-light PDT was in general very well tolerated with a discomfort mean level score of 0.5 ± 1.

Conclusion: This proof-of-concept study supports the efficacy of 5% ALA thermosetting gel red-light PDT in inflammatory acne of the face with a relevant clinical improvement of inflammatory lesions with a very good tolerability profile. Clinical improvement was maintained in the medium term (Trial Registration Number: ISRCTN66066651).
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http://dx.doi.org/10.1111/jocd.12670DOI Listing
February 2019

Antiaging efficacy of melatonin-based day and night creams: a randomized, split-face, assessor-blinded proof-of-concept trial.

Clin Cosmet Investig Dermatol 2018 24;11:51-57. Epub 2018 Jan 24.

Derming, Clinical Research and Bioengineering Institute, Milan, Italy.

Background: Skin is a complete and independent melatoninergic system. At the skin level, melatonin (Mel) acts as a relevant antioxidant and cytoprotective substance. Topical application of Mel is considered meaningful, since it can easily penetrate the stratum corneum. Exogenous Mel can be expected to represent a potent antioxidative defense system against skin aging mechanisms. Day and night creams containing Mel, carried in lipospheres (Melatosphere™), have been developed (Nutriage SPF 30 day cream and Nutriage night cream).

Study Aim: The aim of this study was to evaluate the efficacy of a Mel-based cream as antiaging treatment.

Subjects And Methods: In a randomized, split-face, assessor-blinded, prospective 3-month study, 22 women (mean age 55 years) with moderate-severe skin aging were enrolled (clinical trial registration number: NCT03276897). Study products were applied in the morning (Nutriage day cream) and evening (Nutriage night cream) on the right or left side of the face. Primary outcomes were: 1) clinical evaluation of wrinkles' grade (crow's feet and nasolabial folds), surface microrelief, skin tonicity (resistance to pinching and traction, recovery after pinching) and skin dryness and 2) instrumental evaluation of skin roughness and 3D photographic documentation (Vectra H1 images system). Assessments of both clinical and instrumental evaluations were performed at baseline and after 1, 2 and 3 months of treatment by an investigator unaware of treatment allocation.

Results: All the subjects completed the study. Crow's feet was reduced significantly (=0.05) by -15% with the creams in comparison with the non-treated side after 3 months. At the end of the study, surface microrelief (-26.5%), skin profilometry (-13%), skin tonicity (+30%) and skin dryness (-59.5%) significantly improved with active treatment. Both products were well tolerated.

Conclusion: In women with skin aging, Mel-based creams improved significantly skin tonicity and skin hydration with a significant reduction in skin roughness, supporting the skin antiaging effect of this molecule applied topically.
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http://dx.doi.org/10.2147/CCID.S153905DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5788993PMC
January 2018

Treatment of Multiple Actinic Keratosis and Field of Cancerization with Topical Piroxicam 0.8% and Sunscreen 50+ in Organ Transplant Recipients: A Series of 10 Cases.

Case Rep Dermatol 2017 Sep-Dec;9(3):211-216. Epub 2017 Oct 20.

Department of Systems Medicine, Division of Dermatology, University of Rome Tor Vergata, Rome, Italy.

Organ transplant recipient (OTR) subjects are at high risk of skin cancer such as squamous cell carcinoma and basal cell carcinoma. Actinic keratosis (AK) is considered the precursor of these non-melanoma skin cancers. Sun protection is mandatory in subjects with AK and this preventive strategy is very important in OTR. Treatment of the field of cancerization is also crucial to reduce the risk of recurrence of skin lesions in AK and non-melanoma skin cancer patients. Activation of cyclooxygenase 1 and 2 enzymes plays an important role in the pathogenesis of skin cancers. Topical application of cyclooxygenase inhibitors such as diclofenac and, more recently, piroxicam has shown to reduce AK lesions in immunocompetent subjects. A medical device containing piroxicam and SPF 50+ sunscreen filters (P+SS) has been demonstrated to be effective in reducing AK lesions and improving the field of cancerization. We report the effect of P+SS, applied for 16 weeks, in a case series of 10 OTR subjects with multiple AK lesions. P+SS treatment was associated with a relevant AK lesion reduction (>75%) in 7 patients (with a complete clearance in 3 subjects) with an improvement in the field of cancerization. This medical device could be considered a promising long-term curative and preventive treatment in OTR patients at high risk of non-melanoma skin cancers.
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http://dx.doi.org/10.1159/000481770DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5731151PMC
October 2017

A two-center, assessor-blinded, prospective trial evaluating the efficacy of a novel hypertonic draining cream for cellulite reduction: A Clinical and instrumental (Antera 3D CS) assessment.

J Cosmet Dermatol 2018 Jun 4;17(3):448-453. Epub 2017 Dec 4.

Medical Department, Difa Cooper, IFC Group, Caronno Pertusella, Italy.

Introduction: Gynoid lipodystrophy, also known as cellulite, is a very common skin alteration representing mainly a cosmetic problem rather than a real disease. An effective treatment of cellulite has not been well established. The initial phase of cellulite is characterized by subdermal tissue edema with interstitial fluids retention. A new hypertonic topical product with draining action (HTC) containing NaCl 13%, escine, caffeine, and beta-sitosterol has been recently developed. A 28-day double-blind placebo-controlled study has shown that this cream is able to reduce thigh circumference and the thickness of adipose tissue. No data so far are available regarding an objective evaluation of skin appearance for a longer application period.

Study Aim: To evaluate the clinical efficacy of 2-month HCT treatment with clinical and instrumental assessments.

Subjects And Methods: In a prospective, 2-center, assessor-blinded trial 20 women (mean age 34 years) with cellulite of Grade I-III in severity were enrolled after their informed consent. HTC was applied once daily for 60 days. Primary outcomes of the trial were the evolution of thigh circumference measurements (assessed at baseline, after 1 and 2 months) and the computer-analysis of skin profilometry (ie, skin volumes) of a prespecified target area evaluated by means of Antera 3D CS digitalized images (assessed at baseline and at the end of the trial). Secondary outcome was the orange peel severity score (from 0 to 5) before and after pitch test.

Results: All subjects concluded the study period. Thigh circumference was reduced by -0.88 (right)/-1.2 cm (left) and by -1.8(right)/-2.1 (left) cm, after 30 and 60 days of treatment, respectively (P = .001, Wilcoxon test vs baseline). Antera 3D profilometry of the target zone showed a significant reduction in skin depression expressed in mm of -56% (from 59.7 to 26.73 mm ) after HTC application. Orange peel (no pitch test) mean (SD) score was 2.3 (1) at baseline, 2.0 (1) and 1.8 (0.8) after 1 and 2 months (P = .0031), respectively. After-pitch orange peel score was significantly reduced after treatment (from 3.3 to 2.2).

Conclusion: Once daily application of HTC for 2 months has confirmed its efficacy in the improvement of objective and subjective assessments of cellulite parameters.(Trial Number registration: ISRCTN15111614).
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http://dx.doi.org/10.1111/jocd.12467DOI Listing
June 2018

A starch, glycyrretinic, zinc oxide and bisabolol based cream in the treatment of chronic mild-to-moderate atopic dermatitis in children: a three-center, assessor blinded trial.

Minerva Pediatr 2017 Dec;69(6):470-475

Pediatric Clinic San Matteo Hospital, University of Pavia, Pavia, Italy.

Background: Atopic dermatitis (AD) is a very common chronic inflammatory and eczematous skin condition characterized by flares and remissions. Skin barrier alteration or dysfunction is the most relevant patogenetic factor. Topical corticosteroids are the mainstay treatment of AD, especially during flare periods. The daily use of emollients and moisturizers is also considered a relevant adjunctive strategy to improve skin barrier function and skin appearance in AD patients. Long-term use of topical corticosteroids is associated with important drawbacks and side effects. A corticosteroid-free cream containing starch, glycyrretinic acid, zinc oxide and bisabolol (Dermamid™; Difa Cooper, Caronno Pertusella, Varese, Italy) has been designed for the treatment of acute eczematous conditions like diaper dermatitis. However, this formulation could be particularly suitable also for AD. We evaluated in a three-center, assessor-blinded prospective 6-week treatment trial the efficacy and tolerability of this cream in children with chronic mild-to-moderate atopic dermatitis.

Methods: A total of 30 children (mean age 5 years, 18 males and 12 females) with chronic mild to moderate AD, affecting face, lower and upper limbs or trunk, were enrolled after parents' written informed consent. Exclusion criteria were a condition of immunosuppression, acute flares or a positive history of allergy to one of the components of the cream. The primary outcome was the evolution total eczema severity score (TESS) calculated as the sum of the single eczema severity score for each body area involved. Single area Eczema Severity Score (ESS) was calculated assessing eczema, infiltration, lichenification and scraching lesions using a 4-point scale grade (with 0=no sign, and 4=severe sign). A secondary endpoint was the percentage of subjects reaching at least 50% of TESS reduction at week 6 in comparison with baseline. The TESS was evaluated at baseline and after 3 and 6 weeks of treatment (twice daily application) in an assessor-blind fashion.

Results: At baseline the mean (SD) TESS was 11.6 (4.7). TESS was reduced significantly (P=0.0001) to 5.7 (3) after 3 weeks (-51%), and to 3.0 (2.3) at week 6 (-74%). Similar reductions were observed for single area ESS values. The percentage of subjects with at least a >50% reduction of TESS value at the end of the study was 87%. The product was very well tolerated. Only for one patient a mild burning sensation at the application site was reported. All the subjects concluded the trial.

Conclusions: This trial supports the efficacy and the tolerability of a corticosteroid-free cream containing starch, glycyrretinic acid and bisabolol in the treatment of chronic mild to moderate atopic dermatitis in children.
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http://dx.doi.org/10.23736/S0026-4946.17.05015-0DOI Listing
December 2017

Efficacy and Tolerability of Polyphenon E in "Difficult-to-Treat" Multiple Genital Warts in an HIV-Positive Male Subject.

Case Rep Dermatol 2017 May-Aug;9(2):55-59. Epub 2017 Jun 27.

Medical Department, Difa Cooper, Caronno, Italy.

A 55-year-old man, nonsmoker, with a HIV-positive history came to our attention in February 2017. He was on treatment with Stribild, 1 capsule daily (150 mg elvitegravir, 150 mg cobicistat, 200 mg emtricitabine, and 245 mg tenofovir disoproxil). The CD4+/CD8+ cellular count was 326/µL (normal values: 404-1,612); the CD3+/CD8+ cellular count was 819/µL (normal values: 220-1,219). The CD4/CD8 ratio was 0.40 (normal value: >1). Several typical genital wart lesions were present at the penis shaft and at the level of the neck and the corona of glans. These lesions were present for 2 years. Several cryotherapy sessions (a total of 10 procedures) had been performed with partial success. At the initial visit a total of 5 lesions were present. Treatment with topical Polyphenon E 10% 3 times a day was prescribed and started. After 1 month of treatment the lesions were reduced to 2. Treatment was very well tolerated. After 8 weeks of treatment no more lesions were observed and therefore a complete clearance was obtained. Local tolerability was evaluated to be very good by the patient.
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http://dx.doi.org/10.1159/000477839DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5567009PMC
June 2017
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