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Acne Cream Not Linked to Raised Death Risk
Date:1/23/2009

cipients," Weinstock explained. "The question was, might they be effective in preventing skin cancer not in a super high-risk population but a high-risk population.

The study enrolled 1,131 veterans (average age 71), almost all of them male. Participants were randomly assigned to apply a cream containing 0.1 percent tretinoin (the highest dose commercially available) or a placebo cream to their face and ears twice a day.

Patients with a high risk of death within three years, including prior cancer or other serious medical condition such as advanced heart disease, were excluded from the trial.

The trial was halted in May 2004 due to unexpectedly higher death rates in the treatment arm of the study (82 died in the treatment arm, vs. 53 in the placebo arm).

But the absence of a dose-response relationship, several different causes of death, and minimal absorption of the cream indicated that tretinoin was not responsible for the increased mortality, the authors of the new analysis stated. Also, whether or not the veterans smoked or had smoked was not verified, and retinoids have been associated with an increased risk of death among smokers.

Another thing to consider, the study authors pointed out, is that the trial was done in older people, a group that has not specifically been studied in relation to this issue.

OrthoNeutrogena, the makers of Retin-A, concurred with the findings. "The results of this study did not demonstrate a causal relationship between treatment with Tretinoin and mortality," the company said in a statement. "The study author findings are consistent with OrthoNeutrogena's systematic review of available published literature, which did not find evidence of a relationship between any systemic adverse events and topical Tretinoin."

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