• Jon M Hanifin, Charles N Ellis, Ilona J Frieden, Regina Fölster-Holst, Linda F Stein Gold, Angelo Secci, Angela J Smith, Cathy Zhao, Elena Kornyeyeva, and Lawrence F Eichenfield.
• Oregon Health and Science University, Portland, Oregon.
• J. Am. Acad. Dermatol. 2016 Aug 1; 75 (2): 297-305.

BackgroundPeripheral leukocytes in patients with atopic dermatitis (AD) have elevated phosphodiesterase-4 activity, which is associated with production of proinflammatory mediators. OPA-15406 is a phosphodiesterase-4 inhibitor with high selectivity for phosphodiesterase-4-B.ObjectivesWe sought to assess effectiveness and tolerability of topical OPA-15406 in patients with AD.MethodsThis was a randomized, double-blind, vehicle-controlled, phase-II study. Patients 10 to 70 years of age with mild or moderate AD received topical OPA-15406 0.3% (n = 41), OPA-15406 1% (n = 43), or vehicle (n = 37) twice daily for 8 weeks.ResultsThe primary end point, Investigator Global Assessment of Disease Severity score of 0 or 1 with greater than or equal to 2-grade reduction, was met at week 4 in the OPA-15406 1% group (P = .0165 vs vehicle). Mean percentage improvement from baseline Eczema Area and Severity Index score for OPA-15406 1% was notable in week 1 (31.4% vs 6.0% for vehicle; P = .0005), even larger in week 2 (39.0% vs 3.0%; P = .0001), and persisted for 8 weeks. Visual analog scale pruritus scores improved from moderate to mild within the first week in the OPA-15406 1% group (36.4% mean change; P = .0011). OPA-15406 levels in blood were negligible. Incidence of adverse events was low, with most events mild in intensity.LimitationsFurther confirmatory phase-III studies are required.ConclusionOPA-15406 ointment may provide an effective therapeutic modality for patients with mild to moderate AD.Copyright © 2016 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

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