CHICAGO — A nonsteroidal cream that contains glycyrrhetinic acid (2%) and hyaluronic acid is a safe, effective therapy for mild to moderate atopic dermatitis in infants and young children, based on data from 142 patients aged 6 months to 12 years presented at the annual meeting of the Society for Pediatric Dermatology.
The nonsteroidal cream MAS063DP, which is marketed as Atopiclair, demonstrated safety and effectiveness in adults aged 18-84 years with mild to moderate AD in a randomized, double-blind, placebo-controlled study of 218 patients (J. Drugs Dermatol. 2006;5:236-44).
To assess the safety and effectiveness of the cream in children, Dr. Mark Boguniewicz, of the National Jewish Medical and Research Center in Denver, and his colleagues randomized 72 patients to application of the test cream three times daily and 70 patients to application of a placebo cream three times a day for 43 days. The study was sponsored by Sinclair Pharmaceuticals Ltd. and Graceway Pharmaceuticals LLC.
After 8 days, 39% of the patients in the test group met criteria for "almost clear," whereas none of the placebo patients met these criteria, based on the Investigator's Global Assessment scale. After 22 days, 77% of the test group met criteria for "clear" or "almost clear," whereas none of the placebo patients met these criteria. By the end of the study at 43 days, 78% of the test patients were "clear" or "almost clear," compared with fewer than 7% of the placebo patients.
Itchiness also decreased significantly in the test group during the study period. The average scores (on a scale of 0-100 mm) on the Visual Analog Scale, which compared the same lesion at baseline and on the last day of the study, dropped from 60 mm to 13 mm in the test group and from 66 mm to 57 mm in the placebo group.
By the study's end, 81% of the patients and caregivers in the test group reported either "good improvement" or "total resolution," compared with 10% of the placebo group. Similarly, 81% of patients and caregivers in the test group said that they would "definitely" or "likely" continue to use the cream. All reported adverse events were defined as mild to moderate. The most common complaints—a burning sensation on the skin and fever—occurred with the same frequency in both the test and placebo groups (6.9% vs. 7.1%, respectively). The 26 patients who needed rescue medication at any time during the study included significantly fewer patients from the test group (6 patients) than from the placebo group (20 patients).
Atopiclair is approved by the Food and Drug Administration for marketing in the United States, a spokesperson for Sinclair Pharmaceuticals said in an interview, and "has no restrictions on age or duration of use," according to the product Web site.
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