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January 2009

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

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.2-4 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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