January 2009

Dealing With Unanticipated Mortality in a Large Randomized Clinical Trial of Topical Tretinoin

Author Affiliations

Copyright 2009 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.2009

Arch Dermatol. 2009;145(1):76. doi:10.1001/archdermatol.2008.520

 . . . I would urge you to cultivate a keenly skeptical attitude toward the pharmacopeia as a whole. . . . —Sir William Osler, 19071

Millions of people have used topical tretinoin to treat acne and photoaging.24 In this issue, Weinstock et al5 report an unexpected result that led to the premature halt of their randomized, placebo-controlled Department of Veterans Affairs Topical Tretinoin Chemoprevention (VATTC) trial designed to determine whether topical tretinoin, 0.1%, cream prevents basal and squamous cell skin cancer in US veterans. Limited topical tretinoin use (up to twice daily to the face and ears) was associated with increased death (end-of-intervention hazard ratio, 1.54; P = .01).

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