title: End points in dermatologic clinical trials: A review for clinicians.
abstract: Clinical trials are critical for the development of new therapies in dermatology, and their results help determine US Food and Drug Administration (FDA) approval and guide care. Of special relevance is the clinical trial efficacy end point, the metric from which statistically significant outcome is derived. Clinicians' understanding of a clinical trial's end point is necessary for critical analysis of the trial results and for applying those results to daily practice. This review provides practical knowledge and critical evaluation of end points used in treatment approvals by the FDA. The end points for actinic keratosis, acne vulgaris, atopic dermatitis, onychomycosis, and cutaneous ulcer serve as examples.
authors.affiliation: Department of Dermatology and Cutaneous Surgery, University of Miami, Miami, Florida. Electronic address: wei.erin@gmail.com.
authors.forename: Erin X
authors.initials: EX
authors.lastname: Wei
authors.affiliation: Department of Dermatology and Cutaneous Surgery, University of Miami, Miami, Florida.
authors.forename: Robert S
authors.initials: RS
authors.lastname: Kirsner
authors.affiliation: Department of Dermatology and Cutaneous Surgery, University of Miami, Miami, Florida.
authors.forename: William H
authors.initials: WH
authors.lastname: Eaglstein
mesh_terms: D000152:Acne Vulgaris / Q000188:drug therapy; D002986:Clinical Trials as Topic; D003876:Dermatitis, Atopic / Q000188:drug therapy; D017277:Drug Approval; D023381:Endpoint Determination; D006801:Humans; D055623:Keratosis, Actinic / Q000188:drug therapy; D014009:Onychomycosis / Q000188:drug therapy; D012871:Skin Diseases / Q000188:drug therapy*; D012883:Skin Ulcer / Q000188:drug therapy; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration
keywords: acne vulgaris; actinic keratosis; atopic dermatitis; clinical trials; cutaneous wounds; end points; onychomycosis; randomized controlled trials; wound healing