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.