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Kenneth A. Katz, MD, MSc, MSCE

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Amid continuing controversies over drug safety,^1-2 results of a trial of topical tretinoin—a commonly used medication for acne³ and skin wrinkles, hyperpigmentation, and roughness⁴—raise serious concerns for the public health. The Veterans Affairs Topical Tretinoin Chemoprevention (VATTC) trial^5-6 was a vehicle-controlled randomized controlled trial (RCT) that studied whether topical tretinoin, 0.1%, cream applied to the face and ears could prevent nonmelanoma skin cancer. As reported in an abstract published in 2005,⁶ the study observed 1131 subjects for at least 2 years. After 6 years, and about 6 months prior to the study's scheduled conclusion, a safety monitoring committee stopped the study because of excess mortality among subjects who applied tretinoin (n = 82 deaths [14%]) compared with those who applied vehicle (n = 53 [9%]) (P = .01). Differences in mortality from pulmonary disease (12 vs 4) and non–small cell lung cancer (NSCLC) (11 vs 4) were . . . [Full Text of this Article]

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