Imiquimod 5% cream for the treatment of actinic keratosis: results from two phase III, randomized, double-blind, parallel group, vehicle-controlled trials - 24/08/11
, Scott Dinehart, MD b, c, David Whiting, MD d, Peter K Lee, MD, PhD e, Naji Tawfik, MD, PhD f, g, Joseph Jorizzo, MD h, James H Lee, MD, PhD i, Terry L Fox, MS iAbstract |
Background |
The immune system plays a critical role in the development and pathogenesis of actinic keratosis (AK). Imiquimod has been shown to stimulate the cutaneous immune response and be effective for the treatment of nonmelanoma skin cancers.
Objective |
Two phase III, randomized, double-blind, vehicle-controlled studies evaluated the efficacy of imiquimod 5% cream compared with vehicle in the treatment of AK lesions on the face and balding scalp.
Methods |
A total of 436 participants at 24 centers in the United States and Canada were randomized to either imiquimod 5% or vehicle cream. Study cream was applied one time per day, 2 days per week for 16 weeks. Clearance of AK lesions was clinically assessed at an 8-week posttreatment visit.
Results |
The complete clearance rate was 45.1% for the imiquimod group and 3.2% for the vehicle group. The difference in complete clearance rates (imiquimod minus vehicle) was 41.9% with a 95% confidence interval of 34.9% to 49%. The partial (≥75%) clearance rate was 59.1% for the imiquimod group and 11.8% for the vehicle group. The difference in partial clearance rates (imiquimod minus vehicle) was 47.3% with a 95% confidence interval of 39.5% to 55.1%. The median percent reduction in AK lesions was 83.3% for the imiquimod group and 0% for the vehicle group. Local skin reactions were common. Severe erythema was reported by 17.7% of participants who received imiquimod and 2.3% of participants who received vehicle. Overall, imiquimod was very well tolerated.
Conclusion |
Imiquimod 5% cream used 2 times per week for 16 weeks is an effective and well-tolerated treatment for AK.
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 | Supported by 3M Pharmaceuticals, St Paul, Minnesota. Disclosure: Drs Lebwohl, Dinehart, Whiting, P. Lee, Tawfik, and Jorizzo have received support from 3M Pharmaceuticals for performing clinical trials. Drs Jorizzo and P. Lee have served as consultants for 3M Pharmaceuticals. Drs Lebwohl and Tawfik have received speaking honoraria. Dr J. Lee and Mr Fox are employees of 3M Pharmaceuticals. Portions of this information have been presented at the 62nd Annual Meeting of the American Academy of Dermatology, Washington, DC, February 6-11, 2004 and at ACADEMY 2003, Chicago, Ill, July 25-29, 2003. |
Vol 50 - N° 5
P. 714-721 - mai 2004 Retour au numéro
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- Journal of the American Academy of Dermatology Editorial Office call for bound volumes
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