کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
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6069248 | 1587505 | 2016 | 16 صفحه PDF | دانلود رایگان |
BackgroundAdditional topical treatments for atopic dermatitis (AD) are needed that provide relief while minimizing risks.ObjectiveWe sought to assess the efficacy and safety of crisaborole ointment, a phosphodiesterase 4 inhibitor, in two phase III AD studies (AD-301: NCT02118766; AD-302: NCT02118792).MethodsTwo identically designed, vehicle-controlled, double-blind studies enrolled and randomly assigned (2:1, crisaborole:vehicle) patients aged 2 years or older with an Investigator's Static Global Assessment (ISGA) score of mild or moderate for twice-daily application for 28 days. The primary end point was ISGA score at day 29 of clear (0)/almost clear (1) with 2-grade or greater improvement from baseline. Additional analyses included time to success in ISGA score, percentage of patients achieving clear/almost clear, reduction in severity of AD signs, and time to improvement in pruritus.ResultsMore crisaborole- than vehicle-treated patients achieved ISGA score success (clear/almost clear with â¥2-grade improvement; AD-301: 32.8% vs 25.4%, P = .038; AD-302: 31.4% vs 18.0%, P < .001), with a greater percentage with clear/almost clear (51.7% vs 40.6%, P = .005; 48.5% vs 29.7%, P < .001). Crisaborole-treated patients achieved success in ISGA score and improvement in pruritus earlier than those treated with vehicle (both P â¤Â .001). Treatment-related adverse events were infrequent and mild to moderate in severity.LimitationsShort study duration was a limitation.ConclusionsCrisaborole demonstrated a favorable safety profile and improvement in all measures of efficacy, including overall disease severity, pruritus, and other signs of AD.
Journal: Journal of the American Academy of Dermatology - Volume 75, Issue 3, September 2016, Pages 494-503.e6