A comparison of once-daily application of mometasone furoate 0.1% cream compared with twice-daily hydrocortisone valerate 0.2% cream in pediatric atopic dermatitis patients who failed to respond to hydrocortisone

Two hundred and nineteen patients completed this multicenter, randomized, evaluator-blind, parallel-group study evaluating the efficacy and safety of once-daily application of mometasone furoate 0.1% cream compared with twice-daily hydrocortisone valerate 0.2% cream in children with moderate to severe atopic dermatitis. Enrolled patients were between 2 and 12 years of age and had failed to respond to at least 7 consecutive days of treatment with a topical hydrocortisone preparation, with the last application of hydrocortisone occurring within a week before enrolling in the current study. Patients were randomized to treatment from 10 centers in the USA with either mometasone furoate 0.1% cream (n = 109) or hydrocortisone valerate 0.2% cream (n = 110) for up to 3 weeks. At enrollment, a target area of dermatitis (not the face or forehead) of at least 20 cm² was selected by the investigator for specific evaluation of the effects of treatment on disease signs and symptoms. Additionally, patients had to present with at least 15% total body surface involvement, excluding the face and forehead, with the current exacerbation of atopic dermatitis. The severity of erythema, induration/lichenification, scaling/crusting, exudation, excoriation, and pruritus was graded on the following scale: 0 = none; 1 = mild; 2 = moderate; 3 = severe. A total sign/symptom severity score (sum of six individual sign/symptom severity scores) of ≥ 8 was required in the target area (maximum = 18), with a severity score of ≥ 2 required for erythema and for one other sign. Patients were examined on return visits on days 4, 8, 15, and 22 of treatment and the severity of the signs and symptoms present in the target area was rated by the investigator at each visit. Areas outside the target area were also treated with the study medications and evaluated by the investigator in the global response to treatment. The criteria for global clinical response compared to baseline were as follows: cleared (100% improvement); excellent (75-99% improvement); good (50-74% improvement); fair (25-49% improvement); poor (< 25% improvement); exacerbation (a flare-up at a treatment site). No other therapies for atopic dermatitis were permitted.