Publications by authors named "Nilay Kanti Das"

65 Publications

Liposomal amphotericin B is more effective in polymorphic lesions of post kala-azar dermal leishmaniasis.

Indian J Dermatol Venereol Leprol 2021 Apr 23:1-6. Epub 2021 Apr 23.

Department of Pharmacology, Institute of Postgraduate Medical Education and Research, Kolkata, India.

Background: Post kala-azar dermal leishmaniasis (PKDL) is thought to be the reservoir of infection for visceral leishmaniasis in South Asia. The development of strategies for the diagnosis and treatment of PKDL are important for the implementation of the visceral leishmaniasis elimination program.

Aims: Liposomal amphotericin B (L-AMB) has been an overwhelming success in the treatment of visceral leishmaniasis. However, the empirical three-week regimen of L-AMB proposed for PKDL was shown to be inadequate, especially in the macular variant. This study aimed to delineate response of the different variants of PKDL to L-AMB.

Methods: Skin biopsies were collected from PKDL cases at disease presentation and upon completion of treatment with L-AMB. Parasite DNA was detected by Internal Transcribed Spacer-1 PCR (ITS-1 PCR) and quantified by amplification of parasite kDNA. CD68 + macrophages were estimated in tissue sections by immunohistochemistry.

Results: Treatment with L-AMB decreased the parasite load by 97% in polymorphic cases but only by 45% in macular cases. The median parasite load (89965 vs 5445 parasites/μg of genomic DNA) as well as infiltration by CD68+ cells before treatment was much greater in the polymorphic cases.

Limitations: Although monitoring of the parasite load for 12 months post-treatment would have been ideal, this was not possible owing to logistical issues as well as the invasive nature of biopsy collection procedure.

Conclusion: A dramatic decrease in the parasite burden was noted in patients with polymorphic lesions. Although patients with macular disease also had a decrease in parasite burden, this was not as marked as in the polymorphic cases. There was also a significantly greater infiltration of CD68 + macrophages in polymorphic PKDL before therapy.
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http://dx.doi.org/10.25259/IJDVL_338_20DOI Listing
April 2021

Changes in Cytokine Profile with Immunotherapy in Viral Warts using Purified Protein Derivative, Mumps Measles Rubella Vaccine, and Vaccine.

Indian J Dermatol 2021 Jan-Feb;66(1):67-73

Department of Dermatology, Bankura Sammilani Medical College, Kenduadihi, Bankura, West Bengal, India.

Background: Immunotherapy for wart employs ability of immune system to recognize certain viral, bacterial, and fungal antigens in previously sensitized individual inducing Type IV delayed-type hypersensitivity reaction (up-regulated Th1 cytokines IL-1, TNF-α, IFN-γ; down-regulated Th2 cytokines IL-10), not only to injected antigen but also against wart virus.

Aims: To evaluate and compare the pattern of production of Th1 cytokines (IL-1, TNF-α, IFN-γ) and Th2 cytokines (IL-10) in patients receiving immunotherapy with purified-protein-derivative (PPD), (Mw), or mumps-measles-rubella (MMR) vaccine.

Methods: The cohort study conducted on patients receiving immunotherapy with PPD, Mw, or MMR which was injected intradermally at baseline, repeated every 2 weeks for 6 doses?. Five-millilit?e?r blood was collected for evaluation of cytokines at baseline and 12 weeks of treatment. Blood was centrifuged to separate serum, stored at -80°C. Cytokines were measured by ELISA using a standard kit.

Results: Nine participants in PPD group, 11 in Mw group, and 12 in MMR group completed the study. IL-1 was raised from baseline in all study arms and was significant in PPD group ( = 0.008). There was a predicted increase in IFN-γ in Mw and MMR groups but not in the PPD group. In the PPD group, IFN-γ was found to be down regulated. IL-10, a Th 2 cytokine was down regulated in all the groups at the study end from baseline, significantly so in the PPD group ( = 0.027) and MMR group ( = 0.001). TNF-α, being a Th1 cytokine was down regulated in all groups instead of an increase. In PPD group, IL-10 was significantly low at study end in patients who had complete resolution of warts.

Limitations: Longer follow-up could not be done due to logistic issues.

Conclusion: IL-1, TNF-α upregulation and IL-10 downregulation confirm that cytokine milieu plays an important role in wart immunotherapy. TNF-α has no contributory role. IL-10 can be used as a biomarker of complete response in PPD therapy.
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http://dx.doi.org/10.4103/ijd.IJD_206_20DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8061473PMC
April 2021

Therapeutic Modalities in Post Kala-azar Dermal Leishmaniasis: A Systematic Review of the Effectiveness and Safety of the Treatment Options.

Indian J Dermatol 2021 Jan-Feb;66(1):34-43

Department of Dermatology, Bankura Sammilani Medical College, Bankura, West Bengal, India.

Post-kala-azar dermal Leishmaniasis (PKDL) is one of the important neglected tropical diseases, which has a tremendous epidemiological significance, being the reservoir of kala-azar. Relapse and resistance to treatment along with the lack of a drug of choice and consensus treatment guideline pose a significant problem in the management of PKDL. The aim of this article was to review the available therapeutic options for PKDL, with special emphasis on their pharmaco-dynamics, pharmaco-kinetics, effectiveness, safety, tolerability, and cost factor. A comprehensive English language literature search was done for therapeutic options in PKDL across multiple databases (PubMed, EMBASE, MEDLINE, and Cochrane) for keywords (alone and in combination). MeSH as well as non-MeSH terms such as "Kala-azar," "Leishmaniasis" AND "Treatment," "Management," "Antimony Sodium Gluconate," "Meglumine Antimoniate," "Amphotericin B," "Paromomycin," "Miltefosine" were taken into consideration. Among 576 relevant articles, 15 were deemed relevant to this review. These articles were evaluated using "Oxford Centre for Evidence-Based Medicine (OCEBM)" AND "strength of recommendation taxonomy" (SORT) with respect to the level of evidence and grade of recommendation. The review includes 15 studies. The use of sodium stibogluconate is being discouraged because of multiple documented reports of treatment failure. Liposomal amphotericin B is emerging as a favorable option, owing to its superiority in terms of effectiveness and safety profile. Miltesfosine is the drug of choice in India because of the ease of oral administration and minimal risk of toxicity. Isolated Paromomycin alone is not effective in PKDL; however, combination therapy with sodium stibogluconate is found to be safe and effective. Combination of amphotericin B and miltefosine is one of the excellent options. Immunotherapy with combination of alum-precipitated autoclaved Leishmania major (Alum/ALM) vaccine + Bacille Calmette-Gu´erin (BCG) has shown promising results. Kala-azar continues to haunt the tropical countries and PKDL being its reservoir is threatening its elimination. With the availability of drugs such as liposomal amphotericin B and miltefosine, apart from the advent of immunotherapy, the future of treatment of this condition looks promising.
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http://dx.doi.org/10.4103/ijd.IJD_264_20DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8061474PMC
April 2021

Post Kala-Azar Dermal Leishmaniasis: Clinical Features and Differential Diagnosis.

Indian J Dermatol 2021 Jan-Feb;66(1):24-33

Department of Dermatology, Bankura Sammilani Medical College, Bankura, West Bengal, India.

Post kala-azar dermal leishmaniasis (PKDL) is a mucocutaneous disease usually seen in apparently cured, inadequately treated or untreated cases of visceral leishmaniasis and is endemic to many parts of India, Nepal, Bangladesh, and eastern Africa (Sudan, Ethiopia, Kenya). The disease usually manifests as a variable combination of hypopigmented patches, erythematous succulent papulo-plaques, and nodular lesions on the face and upper body and sometimes extending on the extremities, genitalia, and tongue. Atypical morphology and presentations are not uncommon, especially in endemic areas, which include photosensitivity, verrucous, hypertrophic, xanthomatous, and ulcerative lesions. Recognition of spectrum of mucocutaneous changes helps physicians in early initiation of treatment and in reducing disease transmission in the community. The differential diagnosis depends on the pattern of manifestations, but lepromatous leprosy is the closest mimicker. Since PKDL does not cause significant morbidity, at least initially, but the affected patients continue to act as a reservoir of the disease, active case detection is required to identify cases early to control the disease transmission in the community.
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http://dx.doi.org/10.4103/ijd.IJD_602_20DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8061484PMC
April 2021

Epidemiology of Post-Kala-azar Dermal Leishmaniasis.

Indian J Dermatol 2021 Jan-Feb;66(1):12-23

Department of Dermatology, Bankura Sammilani Medical College, Bankura, West Bengal, India.

Post-kala-azar dermal leishmaniasis (PKDL) is a cutaneous sequel of visceral leishmaniasis (VL) or kala-azar and has become an entity of epidemiological significance by virtue of its ability to maintain the disease in circulation during inter-epidemic periods. PKDL has been identified as one of the epidemiological marker of "kala-azar elimination programme." Data obtained in 2018 showed PKDL distribution primarily concentrated in 6 countries, which includes India, Sudan, south Sudan, Bangladesh, Ethiopia, and Nepal in decreasing order of case-burden. In India, PKDL cases are mainly found in 54 districts, of which 33 are in Bihar, 11 in West Bengal, 4 in Jharkhand, and 6 in Uttar Pradesh. In West Bengal the districts reporting cases of PKDL cases include Darjeeling, Uttar Dinajpur, Dakshin Dinajpur, Malda, and Murshidabad. The vulnerability on the young age is documented in various studies. The studies also highlights a male predominance of the disease but recent active surveillance suggested that macular form of PKDL shows female-predominance. It is recommended that along with passive case detection, active survey helps in early identification of cases, thus reducing disease transmission in the community. The in 2017 introduced by Government of India with the goal to eliminate Kala-azar as a public health problem, targets to reduceing annual incidence <1/10,000. is the established causative agent, but others like or may occasionally lead to the disease, especially with HIV-co-infection. Dermal tropism of the parasite has been attributed to overexpression of parasite surface receptors (like gp 63, gp46). Various host factors are also identified to contribute to the development of the disease, including high pretreatment IL 10 and parasite level, inadequate dose and duration of treatment, malnutrition, immuno-suppression, decreased interferon-gamma receptor 1 gene, etc. PKDL is mostly concentrated in the plains below an altitude of 600 mts which is attributed to the environment conducive for the vector sand fly (). Risk factors are also linked to the habitat of the sand fly. Keeping these things in mind "Integrated vector control" is adopted under as one of the strategies to bring down the disease burden.
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http://dx.doi.org/10.4103/ijd.IJD_651_20DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8061485PMC
April 2021

Post Kala-azar Dermal Leishmaniasis.

Authors:
Nilay Kanti Das

Indian J Dermatol 2020 Nov-Dec;65(6):450-451

Bankura Sammilani Medical College, Bankura, West Bengal, India E-mail:

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http://dx.doi.org/10.4103/ijd.IJD_439_20DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7810095PMC
January 2021

Exploring the safety and effectiveness of subcutaneous autologous serum therapy versus conventional intramuscular autologous serum therapy in chronic urticaria: An observer-blind, randomized, controlled study.

Indian J Dermatol Venereol Leprol 2020 Nov-Dec;86(6):632-642

Department of Dermatology, Bankura Sammilani Medical College, Bankura, West Bengal, India.

Background: Autologous serum therapy aims to supplement the existing pharmacotherapy in chronic urticaria by decreasing the antihistamine pill-burden and maintaining symptom-free interval. Subcutaneous autologous serum therapy further modifies the amount of serum (2 mL to 1 mL) and gauge of a needle (24G to 31G) to improve compliance and facilitate ease of application.

Objectives: To assess clinical effectiveness and safety of subcutaneous autologous serum therapy versus conventional intramuscular autologous serum therapy and to compare the quality of life in the two treatment arms.

Methods: Institution-based, assessor-blind, prospective, randomized, parallel-group, active-controlled trial with 32 patients in each treatment arm and analyzed on a modified intention to treat principle. After baseline autologous serum skin test, autologous serum was injected as per randomization every week for 9 consecutive weeks.

Results: Among the study population, conventional intramuscular autologous serum therapy and subcutaneous autologous serum therapy had a comparable duration of disease (P = 0.164, Mann-Whitney U test), autoreactive status (P = 0.796), urticaria total severity score (P = 0.637) and urticaria activity score summed up over 7 days (P = 0.982). Both urticaria activity score summed up over 7 days and total severity score along with antihistamine pill-burden reduced significantly (P < 0.001, Friedman's analysis of variance) in both subcutaneous autologous serum therapy and conventional intramuscular autologous serum therapy from first follow-up onwards (P < 0.05, Post hoc Dunn's test). Significant improvement was noted in patient's as well as physician's global assessment of disease activity improvement scale (P < 0.001, Friedman's analysis of variance). Intergroup analysis showed that there was no significant difference in urticaria activity score summed up over 7 days either at baseline (P = 0.982, Mann-Whitney U test) or at study end (P = 0.398, Mann-Whitney U test). Similar comparable results were found in the total severity score at the end of the study (P = 0.345, Mann-Whitney U test). Dermatology life quality index showed marked improvement with both types of treatment (P < 0.0001, Wilcoxon test), and the intergroup comparison showed comparable dermatology life quality index values (P = 0.994, Mann-Whitney U test). The pain score at the injection site was more with conventional intramuscular autologous serum therapy than subcutaneous autologous serum therapy (P = 0.0115, Mann-Whitney test). Younger age and lower baseline total severity scores were associated with a better therapeutic response. Baseline urticaria activity score added up over a period of 7 days and total severity scores and the diameter of lesions showed a positive correlation with response pattern.

Limitation: Basophil histamine release assay not done. Logistics could not support follow-up beyond the end of treatment.

Conclusion: Subcutaneous autologous serum therapy is not inferior to conventional intramuscular autologous serum therapy with the additional advantage of less pain and operational feasibility.
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http://dx.doi.org/10.4103/ijdvl.IJDVL_577_19DOI Listing
October 2020

-Value Demystified.

Indian Dermatol Online J 2019 Nov-Dec;10(6):745-750. Epub 2019 Nov 1.

Department of Dermatology, Bankura Sammilani Medical College, Bankura, West Bengal, India.

Biomedical research relies on proving (or disproving) a research hypothesis, and value becomes a cornerstone of "null hypothesis significance testing." value is the maximum probability of getting the observed outcome by chance. For a statistical test to achieve significance, the error by chance must be less than 5%. The pros are the value that gives the strength of evidence against the null hypothesis. We can reject a null hypothesis depending on a small value. However, the value of is a function of sample size. When the sample size is large, the value is destined to be small or "significant." value is condemned by one school of thought who claims that focusing more on value undermines the generalizability and reproducibility of research. For such a situation, presently, the scientific world is inclined in knowing the effect size, confidence interval, and the descriptive statistics; thus, researchers need to highlight them along with the value. In spite of all the criticism, it needs to be understood that value carries paramount importance in "precise" understanding of the estimation of the difference calculated by "null hypothesis significance testing." Choosing the correct test for assessing the significance of the difference is profoundly important. The choice can be arrived by asking oneself three questions, namely, the type of data, whether the data is paired or not, and on the number of study groups (two or more). It is worth mentioning that association between variables, agreement between assessments, time-trend cannot be arrived by calculating the value alone but needs to highlight the correlation and regression coefficients, odds ratio, relative risk, etc.
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http://dx.doi.org/10.4103/idoj.IDOJ_368_19DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6859766PMC
November 2019

Effectiveness and safety of autologous platelet-rich plasma therapy with total contact casting versus total contact casting alone in treatment of trophic ulcer in leprosy: An observer-blind, randomized controlled trial.

Indian J Dermatol Venereol Leprol 2020 May-Jun;86(3):262-271

Department of Dermatology, Bankura Sammilani Medical College, Bankura, West Bengal, India.

Background: Trophic ulcers secondary to leprosy pose a great stigma to patients and remain a challenge to the treating dermatologists. Platelet-rich plasma (PRP) introduces growth factors directly into the wound and aids in rapid healing. The role of PRP in the treatment of trophic ulcers in leprosy patients has not yet been established by randomized controlled trials.

Aims: To study the effectiveness and safety of autologous PRP therapy with total contact casting versus total contact casting alone in the treatment of trophic ulcers in leprosy.

Methods: In an observer-blind, randomized (1:1) controlled study, 118 patients were enrolled. PRP was prepared by the manual double-spin method (1600 rpm for 10 min followed by 4000 rpm for 10 min). After wound bed preparation, activated PRP was injected intra- and perilesionally, and platelet-poor plasma gel was applied over the ulcer bed. Occlusive dressings and total contact casting were then applied in Group A, and only total contact casting was applied in Group B. The same procedure was repeated every 2 weeks for 8 weeks.

Results: In all, 56 patients were analyzable in Group A and 52 in Group B. The surface area of the ulcer decreased significantly from first follow-up onward in both the groups (P < 0.001 in both the groups). Intergroup comparison showed that the reduction in the surface area of the ulcer was significantly more in Group A than in Group B from the first follow-up onward (P = 0.038) and the difference was maintained till the fifth follow-up (P < 0.001). At the end of the study, 91.10 ± 9.65% ulcer surface area reduction had occurred in Group A, whereas it was 79.77 ± 17.91% in Group B (P < 0.001). Trophic ulcers healed completely more often in paucibacillary leprosy patients (P < 0.001) and in those with a lower initial surface area of the ulcer (P < 0.001).

Limitation: Short duration of treatment (8 weeks).

Conclusion: PRP combined with total contact casting accelerates the healing of trophic ulcers of leprosy and is more effective than total contact casting alone. Complete remission is more likely to occur when the duration and surface area of ulcer are less and in the paucibacillary spectrum.
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http://dx.doi.org/10.4103/ijdvl.IJDVL_571_18DOI Listing
November 2020

Author Correction: Impaired activation of lesional CD8 T-cells is associated with enhanced expression of Programmed Death-1 in Indian Post Kala-azar Dermal Leishmaniasis.

Sci Rep 2019 Sep 25;9(1):13997. Epub 2019 Sep 25.

Department of Pharmacology, Institute of Postgraduate Medical Education and Research, Kolkata, 700020, India.

An amendment to this paper has been published and can be accessed via a link at the top of the paper.
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http://dx.doi.org/10.1038/s41598-019-48640-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6761192PMC
September 2019

Selection of Control, Randomization, Blinding, and Allocation Concealment.

Indian Dermatol Online J 2019 Sep-Oct;10(5):601-605. Epub 2019 Aug 28.

Department of Dermatology, Bankura Sammilani Medical College, Kenduadihi, Bankura, West Bengal, India.

Clinical trials looking at which treatment is better must have certain checks in place. Appropriate "control" selection while comparing the investigating agent to the "control group is essential to rule out selection bias. Randomization is another step to minimize variability or "confounders." By randomization, research participants have an equal chance of being selected into any treatment group of the study, generating comparable intervention groups, thereby distributing the confounders. A trial can be "open labeled" or "blinded." By the process of blinding, we make the participant and/or assessing physician unaware of the treatment he/she is going to receive. Thus, the element of bias which can creep in owing to personal preference or subjective component to the assessment of outcome can be eliminated. Concealment of allocation is done as the participant enters the trial. Concealment secures randomization and prevents "selection bias".
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http://dx.doi.org/10.4103/idoj.IDOJ_149_19DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6743387PMC
August 2019

In-situ immune profile of polymorphic vs. macular Indian Post Kala-azar dermal leishmaniasis.

Int J Parasitol Drugs Drug Resist 2019 12 22;11:166-176. Epub 2019 Aug 22.

Dept. of Pharmacology, Institute of Post Graduate Medical Education and Research, Kolkata, 700020, India. Electronic address:

Post Kala-azar Dermal Leishmaniasis (PKDL), a sequel of apparently cured Visceral Leishmaniasis presents in South Asia with papulonodular (polymorphic) or hypomelanotic lesions (macular). Till date, the polymorphic variant was considered predominant, constituting 85-90%. However, following active-case surveillance, the proportion of macular PKDL has increased substantially to nearly 50%, necessitating an in-depth analysis of this variant. Accordingly, this study aimed to delineate the cellular infiltrate in macular vis-à-vis polymorphic PKDL. To study the overall histopathology, hematoxylin and eosin staining was performed on lesional sections and phenotyping by immunohistochemistry done in terms of dendritic cells (CD1a), macrophages (CD68), HLA-DR, T-cells (CD8, CD4), B-cells (CD20) and Ki67 along with assessment of the status of circulating homing markers CCL2, CCL7 and CXCL13. In polymorphic cases (n = 20), the cellular infiltration was substantial, whereas in macular lesions (n = 20) it was mild and patchy with relative sparing of the reticular dermis. Although parasite DNA was identified in both variants by ITS-1 PCR, the parasite load was significantly higher in the polymorphic variant and Leishman-Donovan bodies were notably minimally present in macular cases. Both variants demonstrated a decrease in CD1a dendritic cells, HLA-DR expression and CD4 T-cells. In macular cases, the proportion of CD68 macrophages, CD8 T-cells and CD20 B-cells was 4.6 fold, 17.0 fold and 1.6 fold lower than polymorphic cases. The absence of Ki67 positivity and increased levels of chemoattractants suggested dermal homing of these cellular subsets. Taken together, as compared to the polymorphic variant, patients with macular PKDL demonstrated a lower parasite load along with a lesser degree of cellular infiltration, suggesting differences in host-pathogen interactions, which in turn can impact on their disease transmitting potential and responses to chemotherapy.
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http://dx.doi.org/10.1016/j.ijpddr.2019.08.005DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6904817PMC
December 2019

A Randomized, Double-blind Study of Amorolfine 5% Nail Lacquer with Oral Fluconazole Compared with Oral Fluconazole Alone in the Treatment of Fingernail Onychomycosis.

Indian J Dermatol 2019 Jul-Aug;64(4):253-260

Department of Dermatology, Bankura Sammilani Medical College, Bankura, West Bengal, India.

Background: It is a challenge to treat onychomycosis due to frequent treatment failures and relapses. Systemic and topical therapies need to be combined to improve cure rates. Antifungal susceptibility might play a role in the treatment resistance of onychomycosis.

Aims: To compare the safety and effectiveness of amorolfine 5% nail lacquer + oral fluconazole versus only oral fluconazole in the treatment of fingernail onychomycosis.

Methodology: In this double-blind trial (CTRI/2015/02/005369), patients were randomized (1:1) into amorolfine 5% nail lacquer + fluconazole and dummy lacquer + fluconazole. Treatment was given for 3 months with monthly follow-ups. Antifungal sensitivity was carried out for . Effectiveness was assessed by reduction in the number and percentage area of nails involved and mycological cure. At the end of 3-month treatment period, the association between drug sensitivity and treatment response was explored for the infections.

Results: Among 30 study participants, the combination group showed significantly lower number of nail involvement ( = 0.004) and percentage nail involvement ( = 0.005) than only fluconazole group. Pretreatment fungal culture showed a comparable number of dermatophytes, , in both the groups. Sensitivity testing was done for the isolated species. Antifungal sensitivity for ( = 11) was tested, and 8 (72.7%) of the organisms were sensitive to fluconazole (minimum inhibitory concentration [MIC] 1.25 ± 1.19 μg/ml), 100% were sensitive to itraconazole (MIC 0.0726 ± 0.021 μg/ml), and 3 (27.3%) were susceptible-dose dependent (S-DD) to fluconazole (MIC 16 μg/ml). Fluconazole only group patients with who showed resistance to fluconazole did not respond to therapy; however, patients in the combination group showed moderate improvement (reduction in area involvement = 55.56 ± 35.36%).

Conclusion: The combination of amorolfine/fluconazole achieved a higher cure rate not only for sensitive fungus but also for those which were S-DD to fluconazole.
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http://dx.doi.org/10.4103/ijd.IJD_385_17DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6714192PMC
September 2019

A double-blind, randomized controlled trial to compare the effectiveness and safety of purified protein derivative of tuberculin antigen with vaccine in the treatment of multiple viral warts.

Indian J Dermatol Venereol Leprol 2019 Jul-Aug;85(4):355-366

Department of Dermatology, Bankura Sammilani Medical College, Bankura, West Bengal, India.

Background: Present day therapeutic modalities for viral warts are mostly ablative in nature, limited by high recurrence rates and are unsuitable for numerous lesions. Immunotherapy has the potential to overcome these limitations.

Aims: This study aimed at comparing efficacy and safety of and quality of life changes with intradermal purified protein derivative (PPD) of tuberculin antigen and Mycobacterium w (Mw) vaccine in immunotherapy of warts.

Methods: Patients with multiple (≥5) warts were randomized (1:1) into two groups (PPDand, Mw vaccine groups). Fortnightly, 0.1 ml of either medicine was injected intradermally over the deltoidregion till complete resolution or a maximum of six doses. Patients were followed-up for another 3 months for recurrence.

Results: Sixty-four participants received either PPD or Mw vaccine. The number of warts were comparable at baseline (P = 0.089, Mann-Whitney test), and reduced significantly with treatment in both groups (P < 0.001, Friedman's ANOVA), as seen from the fourth follow-up onwards with Mw and fifth follow-up onwards with PPD (P < 0.05, Post hoc Dunn's test). Intergroup comparison showed significantly more (P < 0.05, Mann-Whitney test) reduction with Mw than PPD at the sixth and seventh follow-up. The size of warts also reduced significantly (P < 0.001) in both groups from the third follow-up onwards. Complete remission was more (P = 0.539, Fischer's exact test) in the Mw group (68.8%) than the PPD group (50%); and was significantly higher (P = 0.049, Mann-Whitney test) in patients having shorter duration of warts. Adverse events were significantly more (P < 0.001) with Mw including ulceration (50%), discharge (15.6%), pain-swelling-induration and scar at the injection site (97% each), whereas some of those receiving PPD noted erythema and scaling at the injection site (18.8%), and post-inflammatory hyperpigmentation (12.5%). No recurrence was seen till the end of the study.

Limitation: Unicentric trial.

Conclusion: Intradermal injection of Mw vaccine was more effective but had a higher incidence of adverse effects compared to PPD of tuberculin antigen in patients with warts.
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http://dx.doi.org/10.4103/ijdvl.IJDVL_549_18DOI Listing
December 2019

Effectiveness and Safety of Metformin versus Canthex™ in Patients with Acanthosis Nigricans: A Randomized, Double-blind Controlled Trial.

Indian J Dermatol 2019 Mar-Apr;64(2):115-121

Department of Dermatology, Bankura Sammilani Medical College, Bankura, West Bengal, India.

Background: Acanthosis nigricans has been associated with conditions of insulin resistance such as obesity, polycystic ovary syndrome, and type 2 diabetes. Metformin and alpha-lipoic acid, two types of insulin-sensitizing agents, have been demonstrated to reduce insulin levels and improve insulin sensitivity. Alpha-lipoic acid is available as a fixed-dose combination with biotin, calcium pantothenate, and zinc sulfate as Canthex™.

Aims: This study aimed to compare the effectiveness, safety, and improvement of the insulin resistance profile of Canthex™ and metformin in acanthosis nigricans.

Materials And Methods: In this double-blind, randomized (1:1), active-controlled trial (CTRI/2017/02/007880), participants received either metformin 500 mg BD or Canthex™ BD for 12 weeks. Effectiveness parameters were improvement of severity of neck lesions and neck texture. Serum fasting insulin level, glucose, lipids, body weight, waist circumference, body mass index (BMI), and homeostatic model assessment-insulin resistance (HOMA-IR) were also assessed at baseline and at the end of the study. Adverse effects and changes in routine laboratory parameters were taken as safety parameters.

Results: Thirty-three patients were analyzed by modified-intention-to-treat criteria. Severity of neck lesions and texture were comparable at baseline and it showed significant reduction (<0.001) in both the treatment arms from the first follow-up onward. No intergroup variation was observed in any of the follow-ups. There was reduction in the values of fasting insulin, blood sugar, total cholesterol, and thyroid-stimulating hormone in both the groups. Weight, BMI, and waist circumference and BMI reduced significantly in both the groups. HOMA-IR decreased significantly in metformin group (<0.001).

Conclusion: Canthex™ is as effective and safe as metformin in the management of acanthosis nigricans and associated features of insulin resistance.
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http://dx.doi.org/10.4103/ijd.IJD_417_17DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6440186PMC
April 2019

Active surveillance identified a neglected burden of macular cases of Post Kala-azar Dermal Leishmaniasis in West Bengal.

PLoS Negl Trop Dis 2019 03 11;13(3):e0007249. Epub 2019 Mar 11.

Department of Pharmacology, Institute of Post Graduate Medical Education and Research, Kolkata, West Bengal, India.

Background: Post Kala-azar Dermal Leishmaniasis (PKDL) develops in patients apparently cured of Visceral Leishmaniasis (VL), and is the strongest contender for being the disease reservoir. Therefore, existence of a few cases is sufficient to trigger an epidemic of VL in a given community, emphasizing the need for its active detection and in turn ensuring success of the current elimination program. This study explored the impact of active surveillance on the demographic profile of PKDL patients in West Bengal.

Methodology/principal Findings: Patients with PKDL were recruited through passive (2003-date, n = 100) and active surveillance (2015-date, n = 202), the former from outpatient departments of dermatology in medical colleges in West Bengal and the latter through an active door-to-door survey in four VL hyper-endemic districts of West Bengal. Passive surveillance indicated a male preponderance and a predominance of polymorphic lesions, whereas active surveillance indicated absence of any gender bias and more importantly, macular PKDL constituted almost 50% of the population burden. In terms of polymorphic vs. macular PKDL, the former appeared at a later age, their disease duration was longer and had a higher parasite burden. In the polymorphic variant, the lesional distribution was asymmetrical, comprised of papules/nodules/macules that were present mainly in sun-exposed areas whereas in macular cases, the hypopigmented patches were diffusely present all over the body.

Conclusions/significance: Active surveillance unraveled a disease component whose demographic profile showed important differences with PKDL cases who sought treatment in government hospitals. Detection of a higher proportion of macular cases indicates that this variant is not an uncommon presentation as conventionally stated in text books, and should be studied in greater detail to ensure success of the ongoing Leishmaniasis elimination programme.
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http://dx.doi.org/10.1371/journal.pntd.0007249DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6428339PMC
March 2019

Impaired activation of lesional CD8 T-cells is associated with enhanced expression of Programmed Death-1 in Indian Post Kala-azar Dermal Leishmaniasis.

Sci Rep 2019 01 24;9(1):762. Epub 2019 Jan 24.

Department of Pharmacology, Institute of Postgraduate Medical Education and Research, Kolkata, 700020, India.

Post Kala-azar dermal leishmaniasis (PKDL), caused by Leishmania donovani is the dermal sequel of Visceral Leishmaniasis and importantly, is the proposed disease reservoir. The survival of Leishmania parasites within monocytes/macrophages hinges on its ability to effectively nullify immune activation mechanisms. Thus, delineating the disease-promoting immune mechanisms can facilitate development of immunotherapeutic strategies. Accordingly, in the absence of an animal model, this study aimed to delineate the status of CD8 T-cells in patients with PKDL. At disease presentation, the absence of CD4 T-cells at lesional sites was concomitant with an overwhelming infiltration of CD8 T-cells that demonstrated an absence of Perforin, Granzyme and Zap-70, along with an enhanced expression of Programmed Death-1 (PD-1) and the skin-homing CCL17. Additionally, the lesional CCR4CD8 population was associated with an enhanced expression of IL-10 and IL-5. In circulation, the enhanced CD8CCR4 T-cell population and raised levels of CCL17/22 was associated with an increased frequency of PD-1, while CD127 was decreased. Taken together, in PKDL, the enhanced plasma and lesional CCL17 accounted for the dermal homing of CD8CCR4 T-cells, that along with a concomitant upregulation of PD-1 and IL-10 mediated immune inactivation, emphasizing the need for designing immunotherapies capable of reinvigorating T-cell potency.
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http://dx.doi.org/10.1038/s41598-018-37144-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6345993PMC
January 2019

A randomized, double-blind trial of amorolfine 0.25% cream and sertaconazole 2% cream in limited dermatophytosis.

Indian J Dermatol Venereol Leprol 2019 May-Jun;85(3):276-281

Department of Dermatology, Bankura Sammilani Medical College, Bankura, West Bengal, India.

Background: Dermatophytosis is becoming increasingly unresponsive to conventional antifungals. Newer topical antifungals may be more effective in these patients.

Aims: To evaluate and compare the efficacy and safety of amorolfine 0.25% cream and sertaconazole 2% cream in limited tinea cruris/corporis.

Methods: A single-center, randomized (1:1), double-blind, parallel group, active-controlled trial (CTRI/2014/12/005246) was performed. Sixty-six untreated adults with acutely symptomatic tinea cruris/corporis were included in the study. All patients had limited cutaneous involvement and were KOH mount positive. Group A received amorolfine 0.25% cream, and group B received sertaconazole 2% cream twice daily application to the lesions for 4 weeks. After the baseline visit, four follow-up visits were carried out. The outcome measures for effectiveness were clinical and mycological cure. Safety parameters studied were treatment-emergent adverse events and changes in routine laboratory parameters.

Results: Both sertaconazole and amorolfine significantly reduced symptoms (P < 0.001) in both groups. However, improvement in symptoms (pruritus, burning sensation, erythema, scaling and crusting) was significantly greater in the sertaconazole group at every follow-up visit. Sertaconazole cream was also more effective than amorolfine cream in reducing the number of lesions (P = 0.002 at 12 weeks) and improving the Dermatology Life Quality Index (P < 0.001) at all the follow-up visits. Adverse events were similar in the two groups (P = 0.117). Fungal cultures became negative in 92.3% of the sertaconazole group as compared to 80% in the amorolfine group (P = 0.010).

Limitations: Antifungal susceptibility testing could not be done.

Conclusion: Sertaconazole 2% is superior to amorolfine 0.25%, both in terms of effectiveness and tolerability. Improvement can be appreciated from second week onwards.
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http://dx.doi.org/10.4103/ijdvl.IJDVL_907_17DOI Listing
August 2019

Identification of atypical dermal leishmaniasis resolved by restriction fragment length polymorphism.

Indian J Dermatol Venereol Leprol 2020 Jan-Feb;86(1):45-49

Department of Pharmacology, Institute of Postgraduate Medical Education and Research, Kolkata, West Bengal, India.

This case report series alerts to the atypical manifestations of dermal leishmaniasis in an area endemic for post kala-azar dermal leishmaniasis, the sequel to visceral leishmaniasis. We have reported two cases with multiple skin lesions, wherein the rK39 strip test, polymerase chain reaction and parasite load confirmed the presence of Leishmania parasites. The causative parasite was identified as Leishmania major by restriction fragment length polymorphism of the ribosomal DNA Internal Transcribed Spacer-1, overruling the clinical suspicion of post kala-azar dermal leishmaniasis. The third case presented with fever and extensive hypopigmented patches in the upper extremities; parasites were identified in blood and skin by polymerase chain reaction and typed by restriction fragment length polymorphism as Leishmania donovani, establishing this as a case of visceral leishmaniasis concomitant with dermal leishmaniasis, secondary to dissemination of viscerotropic L. donovani. The present case series emphasizes the importance of molecular tools to identify the Leishmania species in order to ensure appropriate treatment.
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http://dx.doi.org/10.4103/ijdvl.IJDVL_14_18DOI Listing
July 2020

Usefulness and Utility of NACO Regime in the Management of Sexually Transmitted Infections: A Pilot Study.

Indian J Dermatol 2017 Nov-Dec;62(6):630-634

Department of Dermatology, Bankura Sammilani Medical College, Bankura, West Bengal, India.

Introduction: Treatment of sexually transmitted infections (STIs) has been made easy for field workers due to syndromic approach. The etiological agent responsible for different STI syndromes needs to be validated from time to time so as to guide the therapeutic regimen.

Aims And Objectives: The aim of this study was to evaluate the etiological agent for STI syndromes and correlate the syndromic diagnosis with etiological diagnosis.

Materials And Methods: The study was conducted over 9 months in all patients attending the STI and Gynaecology Outpatient Department. Syndromic diagnosis was done by STI-trained medical officer of respective clinic. Sample was collected for etiological diagnosis and subjected to relevant investigations. Data were analyzed by applying statistical methods.

Results: Among 308 patients (male:female = 1:3.5), no syndromic diagnosis could be made in 11 cases (all females and had premalignant changes on Pap smear). In 68 patients (22.08%), no etiological diagnosis could be arrived at (mostly genital ulcer disease [GUD]-herpetic [H] and vaginal discharge). In cervical discharge syndrome, six patients (16.7%) showed gonococcus. In GUD-H syndrome, 37 patients (27.027%) were tested positive. In GUD-nonherpetic syndrome, three patients (33.33%) were syphilis, granuloma inguinale, and chancroid (1 each). In urethral discharge syndrome, etiology could not be found in 33 cases (45.45%). In vaginal discharge syndrome ( = 217), etiologies were overlapping as follows: trichomonas vaginalis (76.04%), bacterial vaginosis (40%), gonococcus (24%), and undiagnosed (6.5%).

Conclusion: The present tool for validation of GUD-H can validate only 27% of cases. Overlap of etiologies is mostly common in vaginal discharge syndrome, wherein malignancies and premalignant conditions are overtreated with kits. Validation can be done only in two-third of cases with the available resources. However, syndromic approach provides the opportunity of treating STI without delay.
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http://dx.doi.org/10.4103/ijd.IJD_114_17DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5724312PMC
December 2017

Monitoring of Parasite Kinetics in Indian Post-Kala-azar Dermal Leishmaniasis.

Clin Infect Dis 2018 01;66(3):404-410

Department of Pharmacology, Institute of Postgraduate Medical Education and Research, Kolkata, India.

Background: The potential reservoirs of leishmaniasis in South Asia include relapsed cases of visceral leishmaniasis (VL), patients with post-kala-azar dermal leishmaniasis (PKDL), and an asymptomatically infected population. Therefore, assessment of cure in terms of parasite clearance, early detection of PKDL, and asymptomatic VL are pivotal for ensuring elimination. This study aimed to monitor the efficacy of miltefosine and liposomal amphotericin B (LAmB) in PKDL based on parasite load.

Methods: Patients with PKDL were recruited from the dermatology outpatient departments or during active field surveys. Skin biopsies were collected at disease presentation, immediately at the end of treatment, and 6 months later. The presence of parasite DNA was assessed by internal transcribed spacer-1 polymerase chain reaction, and quantified by amplification of parasite kinetoplastid DNA.

Results: At disease presentation (n = 184), the median parasite load was 5229 (interquartile range [IQR], 896-50898)/μg genomic DNA (gDNA). Miltefosine cleared the parasites to <10 in the macular (n = 17) and polymorphic (n = 21) variants, and remained so up to 6 months later (<10 parasites). LAmB reduced the parasite burden substantially in macular (n = 34; 2128 [IQR, 544-5763]/µg gDNA) and polymorphic PKDL (n = 36; 2541 [IQR, 650-9073]/µg gDNA). Importantly, in patients who returned 6 months later (n = 38), a resurgence of parasites was evident, as the parasites increased to 5665 (IQR, 1840-17067)/µg gDNA.

Conclusions: This study established that quantifying parasite load is an effective approach for monitoring patients with PKDL, wherein miltefosine demonstrated near-total parasite clearance and resolution of symptoms. However, in cases treated with LAmB, the persistence of parasites suggested treatment inadequacy. This needs immediate redressal in view of the leishmaniasis elimination program targeted for 2020.
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http://dx.doi.org/10.1093/cid/cix808DOI Listing
January 2018

Ethics of Safety Reporting of a Clinical Trial.

Indian J Dermatol 2017 Jul-Aug;62(4):387-391

Department of Dermatology, Bankura Sammilani Medical College, Bankura, West Bengal, India.

Clinical trial related injury and serious adverse events (SAE) are a major area of concern. In all such scenarios the investigator is responsible for medical care of the trial participant and also ethically bound to report the event to all the stakeholders of the clinical trial. The trial sponsor is responsible for ongoing safety evaluation of the investigational product, reporting and compensating the participant in case of any SAE. The Ethics Committee and regulatory body of the country are to uphold the ethical principles of beneficence, justice, non-maleficence in such cases. Any unwanted and noxious effect of a drug when used in recommended doses is an adverse drug reaction (ADR) whereas if causal association is not yet established it is termed adverse event (AE). An AE or ADR that is associated with death, in-patient hospitalization, prolongation of hospitalization, persistent or significant disability or incapacity, a congenital anomaly, or is otherwise life threatening is termed as an SAE. The principal investigator reports the event to the licensing authority (DCGI), sponsor and Chairperson of the Ethics Committee (EC) within 24 hours of occurrence of the SAE. This report is furthered by a detailed report by both the investigator and the EC and given to the DCGI who then gives a final decision on the amount of compensation to be given by the sponsor or the sponsor's representative to the grieving party.
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http://dx.doi.org/10.4103/ijd.IJD_273_17DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5527719PMC
August 2017

Informed Consent Process: Foundation of the Researcher-participant Bond.

Indian J Dermatol 2017 Jul-Aug;62(4):380-386

Department of Dermatology, Bankura Sammilani Medical College, Bankura, West Bengal, India.

Consenting to participate in a clinical research study after being properly and correctly informed upholds the basic ethical principle of "autonomy" in human research. The informed consent is a process by which the physician sensitizes the patient about the nature, procedures, risks benefits, treatment schedules, etc of the study in a language that is non-technical and understandable by the study participant. Informed consent document (ICD) has got two parts: the 'Subject Information Sheet' and the 'Informed Consent Form' (ICF); and they have to be approved by the Institutional Ethics Committee (IEC) before administration. Consent should be obtained without any coercion. In case of a situation where a participant is not able to give informed consent (e.g. unconscious, minor or those suffering from severe mental illness or disability) or is illiterate, it has be obtained from a legally acceptable representative (LAR). If the participant or LAR is unable to read/write, then an impartial witness should be present during the entire informed consent process and must append his/her signatures to the consent form. For children < 7 years, verbal consent is essential and for mature minors (age group 7 to 18 years) informed assent should be obtained.
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http://dx.doi.org/10.4103/ijd.IJD_272_17DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5527718PMC
August 2017

Evolution of Ethics in Clinical Research and Ethics Committee.

Indian J Dermatol 2017 Jul-Aug;62(4):373-379

Department of Pharmacology, Institute of Post Graduate Medical Education and Research, Kolkata, India.

Ethics are the moral values of human behavior and the principles which govern these values. The situation becomes challenging for a doctor when he assumes the role of researcher. The doctor-researcher has to serve both the roles and at times the zeal of an investigator has the potential to cloud the morality of the physician inside. It is very important to realize that exploiting the faith of patients is an offence that tantamount to a crime. Medical science is one discipline where the advancement of knowledge is hugely guided by research and mankind has benefitted from many experiments. However benefit and risk are the two faces of the same coin. Various unethical human experiments made us realize that the whims of researchers need to be reined and led to the evolution of the first guidelines for researcher, the Nuremberg code. Thereafter the Good Clinical Practice guidelines serve as the guiding doctrine of clinical research. The principles of ethics rest on the four pillars of autonomy, beneficence, justice, non-maleficence and recently two more pillars are added which includes, confidentiality and honesty. Ethics committees serve as a guardian of these principles. The multidisciplinary Ethics Committee ensures a competent review of the ethical aspects of the project proposal submitted and does it free from any bias or external influence. Ethical review of clinical trial applications follows a decentralized process in India, and requires Ethics Committee approval for each trial site. All Ethics committees have to be registered with Drug Controller General of India (DCGI) without which they cannot approve any clinical trial protocol and has come into effect from 25th February 2013.
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http://dx.doi.org/10.4103/ijd.IJD_271_17DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5527717PMC
August 2017

Ethical Issues Pertinent to Current Clinical Research Environment in India.

Authors:
Nilay Kanti Das

Indian J Dermatol 2017 Jul-Aug;62(4):371-372

Department of Dermatology, Bankura Sammilani Medical College, Bankura, West Bengal, India.

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http://dx.doi.org/10.4103/ijd.IJD_270_17DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5527716PMC
August 2017

Effectiveness and safety of levocetirizine 10 mg versus a combination of levocetirizine 5 mg and montelukast 10 mg in chronic urticaria resistant to levocetirizine 5 mg: A double-blind, randomized, controlled trial.

Indian J Dermatol Venereol Leprol 2017 Sep-Oct;83(5):561-568

Department of Dermatology, Medical College and Hospital, Kolkata, West Bengal, India.

Background: Chronic urticaria is a vexing problem for patients and treating physicians alike. The EAACI/GA[2]LEN/EDF/WAO guidelines advocate an increased antihistamine dosage up to four times the standard, before adding leukotriene receptor antagonists. Patients are frequently intolerant of these higher dosages. We conducted this study to determine whether the addition of leukotriene receptor antagonists to the standard antihistamine dose was comparable to higher dosages of antihistamines alone, in terms of efficacy, safety and quality of life changes. We compared levocetirizine 10 mg (double dose of standard) versus a combination of levocetirizine 5 mg and montelukast 10 mg in cases of chronic urticaria not responding to single daily dose of 5 mg levocetirizine.

Methods: A single-center, double-blind, randomized, active-controlled, parallel group phase IV trial (CTRI/2014/12/005261) was conducted on 120 patients of chronic urticaria of either sex not responding to 5 mg levocetirizine. Patients were randomized into receiving either levocetirizine 10 mg or levocetirizine 5 mg + montelukast 10 mg for 4 weeks. Primary outcome measures were Urticaria Activity Score (UAS) and Urticaria Total Severity Score (TSS). Routine hematological and biochemical tests and treatment-emergent adverse events were monitored for safety.

Results: Fifty-two patients on levocetirizine 10 mg group and 51 patients on levocetirizine 5 mg + montelukast 10 mg group were analyzed. UAS and TSS reduced significantly in both treatment groups and reduction of score were comparable in between the groups (P = 0.628, P = 0.824, respectively). Among adverse effects, sedation was noted significantly more (P = 0.013) in levocetirizine 10 mg group. Quality of life was significantly improved in levocetirizine 5 mg + montelukast 10 mg group (P = 0.031).

Limitations: The limitation of the study was that the follow-up period was 4 weeks.

Conclusion: EAACI/GA[2]LEN/EDF/WAO guidelines need to be more flexible in allowing usage of montelukast before escalation of anti-histamine dosage.
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http://dx.doi.org/10.4103/ijdvl.IJDVL_551_16DOI Listing
May 2018

Effectiveness, safety and tolerability of cyclosporine versus supportive treatment in Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis: A record-based study.

Indian J Dermatol Venereol Leprol 2017 May-Jun;83(3):312-316

Department of Dermatology, Medical College and Hospital, Kolkata, West Bengal, India.

Background: Toxic epidermal necrolysis and Stevens-Johnson syndrome comprise life-threatening, drug-induced mucocutaneous disease spectrum. Interest in cyclosporine, a calcineurin inhibitor that can block the function of T-cells, has increased with the discovery of the importance of granulysin in apoptosis in toxic epidermal necrolysis. In our hospital, cyclosporine is given to Stevens-Johnson syndrome/toxic epidermal necrolysis patients as an adjunctive therapy.

Aims: This study is an observational, record-based study comparing the effectiveness and safety of patients receiving cyclosporine versus only supportive therapy.

Methodology: Medical records as bed-head tickets and laboratory investigation reports of Stevens-Johnson syndrome/toxic epidermal necrolysis patients admitted in the hospital over a period of 1 year were collected. Data regarding clinico-demographic profile, suspected drug causing Stevens-Johnson's syndrome/toxic epidermal necrolysis, SCORTEN, body surface area involved, treatment received and outcome were obtained.

Results: Twenty-eight patients were analyzed. Nineteen belonged to the cyclosporine group (supportive treatment + cyclosporine), nine to supportive treatment only group. Among the suspected drugs, antiepileptics formed the major group (28.6%). Five patients in the supportive only group and one in the cyclosporine group died. Time for stabilization and reepithelialization and duration of recovery were significantly lower in the cyclosporine group (P < 0.001, P= 0.007, P= 0.01, respectively). The standardized mortality ratio was 0.32 in cyclosporine group which is nearly 3.3 times lower than the only supportive treatment.

Limitations: As it was a record-based study, certain confounding factors (serum blood urea nitrogen) could not be adjusted.

Conclusion: Cyclosporine (5 mg/kg/day) for 10 days from onset of Stevens-Johnson syndrome/toxic epidermal necrolysis may decrease the risk of dying, may provide faster healing of lesions and might lead to early discharge from hospital.
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http://dx.doi.org/10.4103/ijdvl.IJDVL_201_16DOI Listing
March 2018

Immunotherapy in viral warts with intradermal Calmette-Guerin vaccine versus intradermal tuberculin purified protein derivative: A double-blind, randomized controlled trial comparing effectiveness and safety in a tertiary care center in Eastern India.

Indian J Dermatol Venereol Leprol 2017 May-Jun;83(3):411

Department of Dermatology, Medical College and Hospital, Kolkata, West Bengal, India.

Background: Current therapeutic modalities for viral warts are mostly ablative and are limited by high recurrence rates besides being unsuitable for numerous lesions. Immunotherapy has the potential to overcome these limitations.

Aims: The aim of this study was to compare the effectiveness and safety of Bacillus Calmette-Guerin vaccine versus tuberculin purified protein derivative in the immunotherapy of warts.

Methods: Patients received three doses of 0.1 ml of Bacillus Calmette-Guerin vaccine or tuberculin purified protein derivative intradermally over the deltoid region at 4-weekly intervals. They were followed-up for another month. Number of warts, complete cure rates and quality of life were assessed.

Results: A total of 60 patients were included. Complete clearance was noted in 16 (48.5%) out of 33 patients in the Bacillus Calmette-Guerin group and in 5 (18.5%) out of 27 in the tuberculin purified protein derivative group (P = 0.121). The number of lesions reduced statistically significantly from baseline in both the groups (P < 0.001) from the first follow-up visit onward (P < 0.05). The reduction was statistically significantly more in the Bacillus Calmette-Guerin group than in the tuberculin purified protein derivative group from the second follow-up onward. Dermatologic life quality index improved statistically significantly with both treatments. Adverse events (pain during injection, abscess formation and scarring at injection site) were more frequent with Bacillus Calmette-Guerin. No recurrence was seen after lesions cleared.

Limitations: Patients were not followed up for more than 4 weeks after treatment. We could not estimate the cytokine levels or the peripheral blood mononuclear cell proliferation in response to Bacillus Calmette-Guerin/tuberculin purified protein derivative injections.

Conclusion: Both intradermal Bacillus Calmette-Guerin and tuberculin purified protein derivative hold promise in the treatment of viral warts. Bacillus Calmette-Guerin may be more effective, though it had more adverse events in our study.
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http://dx.doi.org/10.4103/0378-6323.193623DOI Listing
March 2018

Guidelines for the management of Stevens-Johnson syndrome/toxic epidermal necrolysis: An Indian perspective.

Indian J Dermatol Venereol Leprol 2016 Nov-Dec;82(6):603-625

Department of Dermatology, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India.

Background: Stevens-Johnson syndrome and toxic epidermal necrolysis are severe, life-threatening mucocutaneous adverse drug reactions with a high morbidity and mortality that require immediate medical care. The various immunomodulatory treatments include systemic corticosteroids, cyclosporine, intravenous immunoglobulin, cyclophosphamide, plasmapheresis and tumor necrosis factor-α inhibitors.

Aim: The ideal therapy of Stevens-Johnson syndrome/toxic epidermal necrolysis still remains a matter of debate as there are only a limited number of studies of good quality comparing the usefulness of different specific treatments. The aim of this article is to comprehensively review the published medical literature and frame management guidelines suitable in the Indian perspective.

Methods: The Indian Association of Dermatologists, Venereologists and Leprologists (IADVL) assigned the task of preparing these guidelines to its special interest group on cutaneous adverse drug reactions. The group performed a comprehensive English language literature search for management options in Stevens-Johnson syndrome/toxic epidermal necrolysis across multiple databases (PubMed, EMBASE, MEDLINE and Cochrane) for keywords (alone and in combination) and MeSH items such as "guidelines," "Stevens-Johnson syndrome," "toxic epidermal necrolysis," "corticosteroids," "intravenous immunoglobulin," "cyclosporine" and "management." The available evidence was evaluated using the strength of recommendation taxonomy and graded using a three-point scale. A draft of clinical recommendations was developed on the best available evidence which was also scrutinized and critically evaluated by the IADVL Academy of Dermatology. Based on the inputs received, this final consensus statement was prepared.

Results: A total of 104 articles (meta-analyses, prospective and retrospective studies, reviews [including chapters in books], previous guidelines [including Indian guidelines of 2006] and case series) were critically evaluated and the evidence thus gathered was used in the preparation of these guidelines.

Recommendations: This expert group recommends prompt withdrawal of the culprit drug, meticulous supportive care, and judicious and early (preferably within 72 h) initiation of moderate to high doses of oral or parenteral corticosteroids (prednisolone 1-2 mg/kg/day or equivalent), tapered rapidly within 7-10 days. Cyclosporine (3-5 mg/kg/day) for 10-14 days may also be used either alone, or in combination with corticosteroids. Owing to the systemic nature of the disease, a multidisciplinary approach in the management of these patients is helpful.
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http://dx.doi.org/10.4103/0378-6323.191134DOI Listing
May 2017

A Clinicopathological Study of Pemphigus in Eastern India with Special Reference to Direct Immunofluorescence.

Indian J Dermatol 2016 May-Jun;61(3):288-94

Department of Dermatology, Medical College and Hospital, Kolkata, West Bengal, India.

Background: Pemphigus is a group of chronic autoimmune vesico-bullous disorders in which the epidermis and the basement membrane zone are the focus of attack resulting in cutaneous and mucosal blister formation. Direct immunofluorescence (DIF) test is a very sensitive test for the diagnosis.

Aim: To study the clinico histopathological patterns of pemphigus in eastern India. The study also aims to correlate DIF with clinical and histologic findings as well as severity of skin involvement [scoring systems].

Materials And Methods: Total 41 patients were studied over a period of 1 year in the Post-graduate centre of Dermatology in Eastern India. DIF, histopathology and clinical data were correlated.

Results: In our study Pemphigus vulgaris (PV) was the predominant type with 32 cases followed by 8 cases of pemphigus foliaceus (PF) and a single case of IgA pemphigus. Mean age at presentation was late middle age. Majority of the patients, 26 (63.41%) initially had cutaneous involvement followed by mucosal involvement. In this study group 36 (87.80%) patients showed acantholytic cells on histopathological examination. Most patients of PV showed suprabasal blister 20 (62.50%) followed by intraspinous 5 (15.62%) and subcorneal 5 (15.62%) blister. In majority 28 (87.50%) of the PV patients IgG and C3 antibodies were deposited throughout the epidermis. The strength of antibody positivity was strong in most of the patients (71.87%). In cases of PF mostly IgG 6 (75%) antibodies were deposited in the upper epidermis. DIF intensity had poor correlation with disease activity/severity except in PF.

Conclusion: Almost 85.36% cases of pemphigus were diagnosed clinicopathologically. But 6 cases couldn't be diagnosed accurately on clinicopathological basis and in them DIF was confirmatory. Two cases of pure mucosal PV and 1 case of IgA pemphigus was confirmed by DIF. Two cases of bullous pemphigoid clinico-histologically mimicking PV were also excluded by DIF. So it appears from our study that DIF is confirmatory for diagnosis of pemphigus in all cases.
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http://dx.doi.org/10.4103/0019-5154.182422DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4885181PMC
June 2016
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