End points in dermatologic clinical trials: A review for clinicians

Erin X. Wei, Robert Kirsner, William H. Eaglstein

Research output: Contribution to journalArticle

7 Scopus citations

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.

Original languageEnglish (US)
JournalJournal of the American Academy of Dermatology
DOIs
StateAccepted/In press - 2016

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Keywords

  • Acne vulgaris
  • Actinic keratosis
  • Atopic dermatitis
  • Clinical trials
  • Cutaneous wounds
  • End points
  • Onychomycosis
  • Randomized controlled trials
  • Wound healing

ASJC Scopus subject areas

  • Dermatology

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