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

Authors:
Stefano Veraldi
Stefano Veraldi
University of Milan
Italy
Mauro Barbareschi
Mauro Barbareschi
University of Milan
Italy
Alessandro Martella
Alessandro Martella
University of Modena and Reggio Emilia
Italy
Dr Massimo Milani, MD
Dr Massimo Milani, MD
Medical Department Difa Cooper
Medical Director
Hematology, Allergology Dermatology
Milan, (State) | Italy

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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Source
http://dx.doi.org/10.23736/S0392-0488.17.05623-1DOI Listing
June 2019
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