This multicenter, double-masked, placebo-controlled, randomized study evaluated the efficacy, safety, tolerability, and cosmetic acceptability of
hydrocortisone buteprate 0.1% cream in the treatment of patients with
atopic dermatitis. One hundred ninety-four adults with clinically diagnosed
atopic dermatitis were randomized to treatment with
hydrocortisone buteprate 0.1% cream or placebo (the cream base of the medication) applied topically once daily for 14 days. Investigators assessed the severity of
dermatitis signs on a four-point scale at baseline and on days 3, 7, and 14. Overall improvement was also assessed at each study visit using a seven-point scale. In addition, overall treatment efficacy, tolerability, and cosmetic acceptability of both treatments were evaluated at the last study visit. At each study visit, patients treated with
hydrocortisone buteprate showed significant improvement in mean total lesion scores and overall improvement compared with those receiving placebo. Investigators and patients rated
hydrocortisone buteprate significantly more effective and significantly more tolerable than placebo at the end of the treatment period. In general, most adverse effects were mild to moderate, with a burning sensation (4% of patients using placebo, 2% of patients using
hydrocortisone buteprate) being the most commonly reported. Patients judged both
hydrocortisone buteprate and placebo cosmetically acceptable for daily use.