OPA-15406, a novel, topical, nonsteroidal, selective phosphodiesterase-4 (PDE4) inhibitor, in the treatment of adult and adolescent patients with mild.

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OPA-15406, a novel, topical, nonsteroidal, selective phosphodiesterase-4 (PDE4) inhibitor, in the treatment of adult and adolescent patients with mild to moderate atopic dermatitis (AD): A phase-II randomized, double-blind, placebo-controlled study Jon M. Hanifin, MD, Charles N. Ellis, MD, Ilona J. Frieden, MD, Regina Fölster-Holst, MD, Linda F. Stein Gold, MD, Angelo Secci, MD, Angela J. Smith, PA, Cathy Zhao, PhD, Elena Kornyeyeva, MD, PhD, Lawrence F. Eichenfield, MD Journal of the American Academy of Dermatology Volume 75, Issue 2, Pages 297-305 (August 2016) DOI: 10.1016/j.jaad.2016.04.001 Copyright © 2016 American Academy of Dermatology, Inc. Terms and Conditions

Fig 1 CONSORT flow diagram. Journal of the American Academy of Dermatology 2016 75, 297-305DOI: (10.1016/j.jaad.2016.04.001) Copyright © 2016 American Academy of Dermatology, Inc. Terms and Conditions

Fig 2 Clinician-reported outcomes based on Investigator Global Assessment of Disease Severity (IGA). A, Mean success rates per visit. A successful response was defined as an IGA score of 0 or 1 with at least a 2-grade reduction from baseline. B, Mean rates of an IGA score of 0 or 1 (ie, with or without a 2-grade reduction) per visit. P values are for comparisons with vehicle. Last observation carried forward was used to impute missing data. Journal of the American Academy of Dermatology 2016 75, 297-305DOI: (10.1016/j.jaad.2016.04.001) Copyright © 2016 American Academy of Dermatology, Inc. Terms and Conditions

Fig 3 Subgroup analysis of success rate. Shown are the rates (plus 95% confidence intervals [CI]) at which patients received a score of 0 or 1 and had at least a 2-grade reduction from baseline (BSL) score within the designated subgroups at week 4. BSA, Body surface area; CMH, Cochran-Mantel-Haenszel; IGA, Investigator Global Assessment of Disease Severity; NE, not estimable; RR, responder rate. Journal of the American Academy of Dermatology 2016 75, 297-305DOI: (10.1016/j.jaad.2016.04.001) Copyright © 2016 American Academy of Dermatology, Inc. Terms and Conditions

Fig 4 Clinician-reported outcomes based on the Eczema Area and Severity Index (EASI). A, Numeric least squares mean change from baseline in EASI score. B, Percentage improvement from baseline EASI score. P values are for comparisons with vehicle. Last observation carried forward was used to impute missing data. Journal of the American Academy of Dermatology 2016 75, 297-305DOI: (10.1016/j.jaad.2016.04.001) Copyright © 2016 American Academy of Dermatology, Inc. Terms and Conditions

Fig 5 Patient-reported outcomes. A, Mean change from baseline in visual analog scale (VAS) pruritus scores per visit. B, Mean change from baseline in Dermatology Life Quality Index (DLQI) and the Children's DLQI (CDLQI) per visit. Values on both graphs are least squares means. P values are for comparisons with vehicle. Last observation carried forward was used to impute missing data. Journal of the American Academy of Dermatology 2016 75, 297-305DOI: (10.1016/j.jaad.2016.04.001) Copyright © 2016 American Academy of Dermatology, Inc. Terms and Conditions