Vehicle-controlled, double-blind, randomized study of imiquimod 5% cream applied 3 days per week in one or two courses of treatment for actinic keratoses on the head - 19/08/11
, Scott Dinehart, MD b, Robert Matheson, MD c, Jeffrey K. Moore, MD d, Mark Ling, MD, PhD e, Terry L. Fox, MS f, Scott McRae, MS f, Sandra Fielder, MD f, James H. Lee, MD, PhD f
Reprint requests: Joseph Jorizzo, MD, Wake Forest University School of Medicine, Department of Dermatology, Medical Center Blvd, Winston-Salem, NC 27157.Winston Salem, North Carolina; Little Rock, Arkansas; Portland, Oregon; Evansville, Indiana; Newnan, Georgia; and St Paul, Minnesota
Abstract |
Background |
A shorter dosing regimen of imiquimod for the treatment of actinic keratosis may be effective, with long-term clinical benefits.
Objective |
Imiquimod in one or two shorter courses of treatment was evaluated.
Methods |
Patients with actinic keratosis lesions on the head applied imiquimod or vehicle cream 3×/wk for 4 weeks (course 1). Patients with remaining lesions received another course of treatment. Complete and partial clearance rates were evaluated after course 1, after course 2 (overall), and 1 year later.
Results |
Complete clearance rates were 26.8% (course 1) and 53.7% (overall). Partial clearance rates were 36.6% (course 1) and 61.0% (overall). One-year follow-up recurrence rates were 39% (imiquimod) and 57% (vehicle).
Limitations |
Blinded investigators may have been biased toward patients treated with imiquimod identified by treatment site reactions.
Conclusion |
Imiquimod 3×/wk in one or two courses of treatment appears to be effective for the treatment of actinic keratoses on the head, providing long-term clinical benefits. Some recurrences do occur, so long-term follow-up is recommended.
Il testo completo di questo articolo è disponibile in PDF.Abbreviations used : AEs, AK, LSRs, SCC
Mappa
| Supported by 3M Pharmaceuticals. Disclosure: Drs Jorizzo, Matheson, Moore, Ling, and Dinehart (investigators) have been compensated by 3M Pharmaceuticals for their services in conducting the study reported here. Dr Fielder (medical monitor) and Mr Fox (biostatistician) are employees of 3M Pharmaceuticals. Dr Lee (medical monitor) and Mr McRae (biostatistician) were 3M Pharmaceutical employees at the time of manuscript writing but have since left the company. Presented as posters at the World Congress on Cancers of the Skin, Vienna, Austria, May 2005; Congress of the American Academy of Dermatology, Chicago, Illinois, July 2005; and Fall Clinical Dermatology Conference, Las Vegas, Nevada, October 2005. The following are principal investigators who participated in the study: Joseph Jorizzo, MD (coordinating investigator for course of treatment study); Scott Dinehart, MD (coordinating investigator for follow-up study); Frank Dunlap, MD; Alan Fleischer, MD; Ruth Gilboa, MD; Karen Harkaway, MD; Steven Kempers, MD; David Whiting, MD; Jeffrey Moore, MD; Mark Ling, MD; Robert Matheson, MD; Neil Korman, MD; Jennie Muglia, MD; and Elyse Rafal, MD. |
Vol 57 - N° 2
P. 265-268 - agosto 2007 Ritorno al numero
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