Imiquimod 5% cream for the treatment of actinic keratosis: Results from a phase III, randomized, double-blind, vehicle-controlled, clinical trial with histology

• Published in: Journal of the American Academy of Dermatology 2004-10, Vol.51 (4), p.547-555
• Main Authors: Szeimies, Rolf-Markus, Gerritsen, Marie-Jeanne P., Gupta, Girish, Ortonne, Jean Paul, Serresi, Stefano, Bichel, Jens, Lee, James H., Fox, Terry L., Alomar, Agustı́n
• Format: Article
• Language: English
• Subjects: Aged; Aminoquinolines - pharmacokinetics; Aminoquinolines - therapeutic use; Biological and medical sciences; Confidence Intervals; Dermatology; Double-Blind Method; Dyskeratosis; Female; Humans; Injuries of the skin. Diseases of the skin due to physical agents; Keratosis - complications; Keratosis - drug therapy; Male; Medical sciences; Photosensitivity Disorders - complications; Photosensitivity Disorders - drug therapy; Skin involvement in other diseases. Miscellaneous. General aspects; Traumas. Diseases due to physical agents
• ISSN: 0190-9622; 1097-6787
• DOI: 10.1016/j.jaad.2004.02.022

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. 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. 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. 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. 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.