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Dealing With Unanticipated Mortality in a Large Randomized Clinical Trial of Topical Tretinoin
Lisa M. Schilling, MD, MSPH;
Robert P. Dellavalle, MD, PhD, MSPH
Arch Dermatol. 2009;145(1):76.
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. . . 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).
While some argue that topical tretinoin might increase pulmonary-related mortality,6 Weinstock et al5 ultimately reject this explanation and chalk their results up as a chance finding based on the following: (1) minimal systemic absorption of . . . [Full Text of this Article]
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