Efficacy of desonide 0.05% cream and lotion in steroid-responsive dermatoses in Indian patients: a post-marketing surveillance study.

BACKGROUND: Desonide, a non-halogenated, low-potency topical steroid, is indicated in the treatment of steroid-responsive dermatoses. AIMS: A post-marketing surveillance study was conducted to evaluate the efficacy and safety of Desowen (Desonide 0.05%) cream and lotion in Indian patients for the treatment of steroid-responsive dermatoses of mild to moderate severity. METHODS: A 3-week, multicenter, open-label, non-comparative Phase IV trial involving 1789 patients from 229 centers across India was conducted between January and August 2003. RESULTS: Of the 1789 patients, 1483 patients completed the treatment as per protocol. At the end of the therapy, 98.5% of the patients showed an improvement in their dermatitis from baseline. More than half of the patients showed a greater than 75% improvement in their signs and symptoms. No adverse effects were noted in any of the patients. Both the lotion and cream were found to be equally effective. CONCLUSIONS: Desonide 0.05% is a safe and effective low-potency corticosteroid for the treatment of mild to moderate dermatoses in Indian patients. No clinically apparent side-effects were observed in infants less than 1 year of age.