Imiquimod 5% cream for the treatment of actinic keratosis: Results from a phase III, randomized, double-blind, vehicle-controlled, clinical trial with histology - 24/08/11
, Marie-Jeanne P. Gerritsen, MD b, Girish Gupta, FRCP c, Jean Paul Ortonne, MD d, Stefano Serresi, MD e, Jens Bichel, MD f, James H. Lee, MD, PhD g, Terry L. Fox, MS g, Agustı́n Alomar, MD h
Reprint requests: Rolf-Markus Szeimies, MD, PhD, Klinikum der Universität Regensburg, Klinik und Poliklinik für Dermatologie, Franz-Josef-Strauss-Allee 11, 93042 Regensburg, Germany.Regensburg and Neuss, Germany; Nijmegen, Netherlands; Airdrie, United Kingdom; Nice, France; Ancona, Italy; St Paul, Minnesota; and Barcelona, Spain
Abstract |
Background |
Increasing evidence suggests imiquimod may be a safe therapeutic option for the treatment of actinic keratosis (AK). The diagnosis and assessment of most AK lesions is made clinically, without histologic confirmation.
Objective |
A phase III, randomized, double-blind, parallel group, vehicle-controlled study evaluated the efficacy of imiquimod 5% cream compared with vehicle in the treatment of AK lesions on the face and balding scalp including pretreatment and posttreatment biopsy specimens.
Methods |
A total of 286 patients at 18 centers in 6 European countries with histologically confirmed AK were randomized to either imiquimod 5% cream or vehicle cream. Study cream was applied once per day, 3 days per week, for 16 weeks. Clearance of AK lesions was clinically and histologically assessed at an 8-week posttreatment visit.
Results |
The complete clearance rate for the imiquimod group was 57.1% versus 2.2% for the vehicle group (P < .001). The partial clearance rate (≥75% reduction in baseline lesions) for the imiquimod group was 72.1% versus 4.3% for the vehicle group (P < .001). The most common side effects were erythema, scabbing/crusting, and erosions/ulceration. For the imiquimod group the incidence of severe erythema, scabbing/crusting, or erosions/ulceration was 30.6%, 29.9%, and 10.2%, respectively.
Conclusion |
Imiquimod 5% cream used 3 times per week for 16 weeks is an effective treatment for AK. Clinical clearance was established by both clinical observation and histologic analysis.
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 | Supported by 3M Pharmaceuticals, St Paul, Minn. Disclosure: Drs Szeimies, Gerritsen, Gupta, Ortonne, Serresi, and Alomar have received support from 3M Pharmaceuticals for performing clinical trials. Drs Gupta, Alomar, Ortonne, and Gerritsen have served as consultants and/or received honoraria from 3M Pharmaceuticals. Dr Szeimies is also a consultant for other companies that have and are developing treatments for actinic keratosis. Dr Bichel, Dr Lee, and Mr Fox are employees of 3M Pharmaceuticals. Results have been presented in part at the 12th Congress of the European Academy of Dermatology and Venerology, Barcelona, Spain, October 15-18, 2003. Several abstracts and posters that contain the results presented in this manuscript were presented at the 62nd Annual Meeting of the American Academy of Dermatology, Washington, DC, February 6-11, 2004. |
Vol 51 - N° 4
P. 547-555 - octobre 2004 Retour au numéro
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