Peter Altmeyer1, Klaus Hoffmann. 1. Department of Dermatology, Ruhr-University Bochum, St. Josef-Hospital, Bochum, Germany. p.altmeyer@derma.de
Abstract
BACKGROUND: Seborrheic dermatitis is a common inflammatory skin disorder affecting 1-3% of the population. It is thought to be linked to dandruff via a common etiology, yeasts of the genus Malassezia. Ciclopirox is a broad-spectrum, hydroxypyridone-derived, synthetic antifungal agent with anti-inflammatory properties. METHODS: A total of 203 patients were enrolled in this vehicle-controlled, double-blind, randomized study designed to compare vehicle with three different concentrations of ciclopirox shampoo: 0.1%, 0.3% and 1%, with each applied twice a week. The main efficacy parameters were based on 6-point ordinal scales describing the disease's signs and symptoms (scaling, inflammation and itching), global status of disease, and global change in disease. RESULTS: A tendency towards improvement of the sum score from baseline was found in all ciclopirox treatment groups. The most pronounced improvement was found in the ciclopirox 1% group, which changed from a baseline sum score of 8.3 to 4.4 at the end of the 4-week study period (P-value vs. vehicle 0.0372). In addition, the therapeutic index showed increasing efficacy with the use of increased concentrations of ciclopirox. CONCLUSIONS: The study supports the use of 1% ciclopirox shampoo in the treatment of seborrheic dermatitis of the scalp. Furthermore, ciclopirox shampoo at each concentration was found to be safe and well tolerated.
RCT Entities:
BACKGROUND:Seborrheic dermatitis is a common inflammatory skin disorder affecting 1-3% of the population. It is thought to be linked to dandruff via a common etiology, yeasts of the genus Malassezia. Ciclopirox is a broad-spectrum, hydroxypyridone-derived, synthetic antifungal agent with anti-inflammatory properties. METHODS: A total of 203 patients were enrolled in this vehicle-controlled, double-blind, randomized study designed to compare vehicle with three different concentrations of ciclopirox shampoo: 0.1%, 0.3% and 1%, with each applied twice a week. The main efficacy parameters were based on 6-point ordinal scales describing the disease's signs and symptoms (scaling, inflammation and itching), global status of disease, and global change in disease. RESULTS: A tendency towards improvement of the sum score from baseline was found in all ciclopirox treatment groups. The most pronounced improvement was found in the ciclopirox 1% group, which changed from a baseline sum score of 8.3 to 4.4 at the end of the 4-week study period (P-value vs. vehicle 0.0372). In addition, the therapeutic index showed increasing efficacy with the use of increased concentrations of ciclopirox. CONCLUSIONS: The study supports the use of 1% ciclopirox shampoo in the treatment of seborrheic dermatitis of the scalp. Furthermore, ciclopirox shampoo at each concentration was found to be safe and well tolerated.
Authors: Enembe O Okokon; Jos H Verbeek; Jani H Ruotsalainen; Olumuyiwa A Ojo; Victor Nyange Bakhoya Journal: Cochrane Database Syst Rev Date: 2015-05-02