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

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.