Boguniewicz M, Zeichner JA, Eichenfield LF, et al. J Pediatr. 2008;152(6):854–859
PURPOSE OF THE STUDY. To examine the safety and efficacy of MAS063DP (Atopiclair [Graceway Pharmaceuticals, Bristol, TN]), a topical nonsteroidal antiinflammatory agent, in the management of mild-to-moderate atopic dermatitis in infants and children.
STUDY POPULATION. Infants and children (N = 142) between the ages of 6 months and 9 years with mild-to-moderate atopic dermatitis affecting ≥5% of body surface area and scores of ≥40 of 100 on a visual analog scale (VAS) for pruritus.
METHODS. Subjects were randomly assigned to apply MAS063DP or vehicle cream 3 times per day to affected areas, as well as those prone to flares, after a washout period. Assessments were made at baseline and days 3, 8, 15, 22, 29, and 43. The primary end point was the subject's Investigator's Global Assessment (IGA) score on day 22 (0 indicates clear skin and 5 indicates severe disease activity). Treatment success was defined as an IGA score of 0 or 1. Secondary end points included IGA scores at other time points, subject/caregiver assessment of pruritus as evaluated with the VAS and an ordinal scale of 0 to 3, onset and duration of itch relief, Eczema Area and Severity Index, subject/caregiver assessment of global response, and need for rescue medication during a flare.
RESULTS. For the primary end point of IGA score at day 22, there was a highly significant difference between the 2 groups (analysis of covariance, P < .0001) in favor of the treatment group. In intention-to-treat analysis, 53 (77%) of 69 subjects achieved treatment success, compared with none in the vehicle group. The mean treatment difference was −1.636 (95% confidence interval: −1.928 to −1.344) in favor of MAS063DP. The secondary end point of IGA scores at other time points demonstrated treatment success for 39.1% of the MAS063DP-treated subjects by day 8, 71% by day 15, and 78.2% by day 29. Treatment success in the vehicle-treated group did not exceed 7.1%. The difference was significant at all time points (Fisher's exact test, P < .0001). Other secondary end points that demonstrated significant benefit in the treatment group versus the vehicle group included the VAS score, Eczema Area and Severity Index score, subject/caregiver assessment of global response from baseline, onset of itch relief and duration of action, and need for rescue medication (8.7% in the treatment group and 28.6% in the vehicle group). No serious adverse events were related to MAS063DP, although stinging (8.3%), burning (6.9%), and fever (6.9%) were common adverse events (the latter 2 occurring more frequently in the vehicle group). Rates of treatment discontinuation because of adverse events were 9.9% in the MAS063DP group and 16% in the vehicle group.
CONCLUSIONS. MAS063DP is safe and effective in the treatment of mild-to-moderate atopic dermatitis in infants and children.
REVIEWERS COMMENTS. Concerns about adverse effects of topical corticosteroids and calcineurin inhibitors elicit understandable parental apprehension. The results of this study show promise for an alternative therapy for mild-to-moderate atopic dermatitis in infants and children. Although this study did not monitor for the theoretical risk of systemic toxicity after prolonged use, no systemic adverse events have been reported in post-marketing surveillance.
- Copyright © 2009 by the American Academy of Pediatrics