A double-blind study of tolerance and efficacy of a new urea-containing moisturizer in patients with atopic dermatitis.

ABSTRACT

BACKGROUND: Atopic dermatitis patients almost all use moisturizers to prevent and treat their skin disease. However, the safety and efficacy of moisturizers are rarely studied in this patient population. Aims To evaluate the efficacy and tolerability of urea-containing moisturizers in subjects with atopic dermatitis. METHODS: One hundred subjects with atopic dermatitis were randomized to apply either a new 5% urea moisturizer or a commercially available 10% urea lotion twice a day for 42 days. Scoring Atopic Dermatitis severity index (SCORAD) was performed at Day 0 and Day 42. Cosmetic acceptability questionnaires, adverse events, and a 5-point tolerance evaluation were administered or performed at Day 42. RESULTS: Both study products were very well tolerated by subjects and only three subjects discontinued their participation in the study due to adverse events. Mean SCORAD significantly decreased between Day 0 and Day 42 by 19.76% and 19.23%, respectively, for subjects treated with the new 5% urea moisturizer or the 10% urea lotion (P < 0.001). There was no difference between the two products in SCORAD reduction; however, significantly more subjects preferred using the new 5% urea moisturizer as compared with the 10% urea lotion. CONCLUSIONS: Both the new 5% urea moisturizer and the 10% urea lotion improved atopic dermatitis and were very well tolerated. However, the cosmetic acceptability questionnaire showed that subjects preferred using the new 5% urea moisturizer over the 10% urea lotion.