Imiquimod 5% cream for the treatment of actinic keratosis: results from a phase III, randomized, double-blind, vehicle-controlled, clinical trial with histology.
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 (> or =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.


CONCLUSIONS
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.
Szeimies
Rolf-Markus
RM
Klinikum der Universität Regensburg, Klinik und Poliklinik für Dermatologie, Regensburg, Germany.
Gerritsen
Marie-Jeanne P
MJ
Gupta
Girish
G
Ortonne
Jean Paul
JP
Serresi
Stefano
S
Bichel
Jens
J
Lee
James H
JH
Fox
Terry L
TL
Alomar
Agustín
A
D000368:Aged; D000634:Aminoquinolines / Q000493:pharmacokinetics / Q000627:therapeutic use*; D016001:Confidence Intervals; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D000077271:Imiquimod; D007642:Keratosis / Q000150:complications / Q000188:drug therapy*; D008297:Male; D010787:Photosensitivity Disorders / Q000150:complications / Q000188:drug therapy*
D000634:Aminoquinolines; D000077271:Imiquimod