Document Detail

Tolerability of high-dose topical tretinoin: the Veterans Affairs Topical Tretinoin Chemoprevention Trial.
MedLine Citation:
PMID:  19681859     Owner:  NLM     Status:  In-Process    
BACKGROUND: Topical tretinoin is a medication commonly used for acne that has potential application in the long-term treatment of photodamaged skin. However, there are few published data regarding the tolerability of high-dose tretinoin with long-term use. OBJECTIVES: To assess the long-term tolerability of tretinoin 0.1% cream. METHODS: A randomized, multicentre, double-blind, controlled trial for chemoprevention of keratinocyte carcinomas (i.e. basal cell or squamous cell carcinomas) using topical tretinoin cream to the face and ears was conducted. All participants were veterans and had a history of two or more keratinocyte carcinomas over the previous 5 years. Participants were examined (by a study dermatologist) and interviewed every 6 months (for up to 5.5 years to May 2004). Treatment comprised tretinoin 0.1% cream or vehicle control cream once daily, then twice daily as tolerated. Participants were instructed to step down application frequency to once daily or less if twice daily was not tolerated. The main outcome measures were reported side-effects, frequency of cream application and attendance at study visits. Appropriate data were available for four of the six clinical sites of this trial. RESULTS: Data from 736 randomized participants (mean age 71 years; 97% men) from four clinical sites were analysed. The tretinoin group more commonly reported one or more side-effects at the 6-month follow-up than the control group (61% vs. 42%, P < 0.0001). Side-effects decreased over time in both groups, but to a greater extent in the tretinoin group, and the difference became nonsignificant at 30 months. Burning was the most common side-effect (39% tretinoin vs. 17% control, P < 0.0001). There was no difference in severity of side-effects among those affected. Of the participants who reported burning in either group, most reported mild burning; only 11% of those with burning in the tretinoin group reported it as severe (mild 62% tretinoin vs. 70% placebo; severe 11% vs. 5%; P = 0.4). Itching (24% vs. 16%, P = 0.01) and other local cutaneous reactions (12% vs. 6%, P = 0.01) were also more commonly reported by the tretinoin group at 6 months. There was no difference in numbness (2% vs. 2%, P = 0.9). Participants in the tretinoin group were less likely to apply cream twice daily at 6 months (29% vs. 43%, P = 0.0002). This difference persisted over the entire duration of follow-up. There was little difference between groups in attendance at study visits or completion of telephone interviews (92% vs. 95%, P = 0.06). No unexpected adverse events were reported. CONCLUSIONS: Overall, the tolerability level of topical tretinoin was high in this study population, with almost 40% of the tretinoin group reporting no side-effects, and the majority (67%) tolerating at least once-daily dosing at 6-month follow-up. High-dose topical tretinoin is feasible for long-term use in this population.
A Geng; M A Weinstock; R Hall; D Eilers; M Naylor; J Kalivas;
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Publication Detail:
Type:  Journal Article; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, Non-P.H.S.     Date:  2009-06-11
Journal Detail:
Title:  The British journal of dermatology     Volume:  161     ISSN:  1365-2133     ISO Abbreviation:  Br. J. Dermatol.     Publication Date:  2009 Oct 
Date Detail:
Created Date:  2009-09-28     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0004041     Medline TA:  Br J Dermatol     Country:  England    
Other Details:
Languages:  eng     Pagination:  918-24     Citation Subset:  IM    
Boston Dermatology and Laser Center, Boston, MA, USA.
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Martin Weinstock / ; Kim Marcolivio / ; Martin Weinstock / ; Stephen Bingham / ; John J DiGiovanna / ; Russell Hall / ; Mark Naylor / ; J Richard Taylor / ; Julia Vertrees / ; Clifton White / ; Russell Hall / ; Navjeet Sidhu-Malik / ; Deborah Hannah / ; David Eilers / ; Tehming Liang / ; Nadia Sakla / ; Ann Kreuger / ; Gary Cole / ; Edward Jeffes / ; Terri Labrador / ; J Richard Taylor / ; Robert Kirsner / ; Jonette E Kerri / ; Anna G Falabella / ; Margarita Givens / ; Mark Naylor / ; Mary Beth Benson / ; Lisa Perry / ; James Kalivas / ; Catherine Yanni / ; Selma Targovnik / ; Janet Austin / ; Susan Collier / ; Joseph F Collins / ; Stephen Bingham / ; Beverly Calvert / ; Philip Connor / ; Colleen Crigler / ; Dawn Davis / ; Pat Grubb / ; Judy Kelly / ; Gail Kirk / ; Karen Lawson / ; Linda Linzy / ; Lorrine Palmer / ; Maxine Rhoads / ; Mike Sather / ; Erica Copeland / ; Carol Fye / ; William Gagne / ; Patricia Grimes de Naranjo / ; Chad Messick / ; Julia Vertrees / ; Michael Piepkorn / ; Clifton White / ; Robert Lew / ; Irwin Braverman / ; Bernard Cole / ; Richard Kalish / ; David McLean / ; Bruce Harris Thiers /

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