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

<jats:title>Summary</jats:title><jats:p><jats:bold>Background </jats:bold> 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.</jats:p><jats:p><jats:bold>Aims </jats:bold> To evaluate the efficacy and tolerability of urea‐containing moisturizers in subjects with atopic dermatitis.</jats:p><jats:p><jats:bold>Methods </jats:bold> 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.</jats:p><jats:p><jats:bold>Results </jats:bold> 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 (<jats:italic>P</jats:italic> < 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.</jats:p><jats:p><jats:bold>Conclusions </jats:bold> 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.</jats:p>