A phase 2a study of topical perillyl alcohol cream for chemoprevention of skin cancer.

Cancer Prevention Research
Steven P StrattonPeter H Bartels

Abstract

The chemopreventive and antitumor properties of perillyl alcohol (POH) that were studied preclinically indicate that topical POH inhibits both UVB-induced murine skin carcinogenesis (squamous cell tumor models) and 7,12-dimethylbenz(a)anthracene-induced murine melanoma (transgenic models involving tyrosinase-driven Ras). A previous phase 1 clinical trial in participants with normal-appearing skin showed that topical POH cream was well tolerated at a dose of 0.76% (w/w). Here, we performed a 3-month, double-blind, randomized, placebo-controlled phase 2a trial of two different doses of topical POH in individuals with sun-damaged skin. Participants applied POH cream twice daily to each dorsal forearm. Baseline and end-of-study biopsies were taken from each participant to evaluate whether the topical application of POH was effective in reversing actinic damage as evidenced by normalization of quantitative skin histopathologic scores and change in nuclear chromatin pattern as measured by karyometric analysis. There was a borderline reduction in the histopathologic score of the lower-dose POH group compared with the placebo (P = 0.1), but this was not observed in the high-dose group. However, in the high-dose group, a statistically s...Continue Reading

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Citations

Sep 8, 2011·Dermatologic Surgery : Official Publication for American Society for Dermatologic Surgery [et Al.]·Renata PradoRobert Dellavalle
Mar 24, 2011·Pigment Cell & Melanoma Research·Deeba N Syed, Hasan Mukhtar
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Aug 15, 2012·Expert Opinion on Pharmacotherapy·Brian Berman, Sadegh Amini
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Jan 4, 2013·Molecular and Cellular Biochemistry·Tabetha SundinPatricia Hentosh
Jan 28, 2010·Cancer Prevention Research·John L Clifford, John DiGiovanni

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