Dosing with 5% imiquimod cream 3 times per week for the treatment of actinic keratosis: results of two phase 3, randomized, double-blind, parallel-group, vehicle-controlled trials. Archives of dermatology. [Arch Dermatol] Journal article | | Title | Dosing with 5% imiquimod cream 3 times per week for the treatment of actinic keratosis: results of two phase 3, randomized, double-blind, parallel-group, vehicle-controlled trials. | | Author(s) | Korman N, Moy R, Ling M, Matheson R, Smith S, McKane S, Lee JH | | Institution | Department of Dermatology, University Hospitals of Cleveland, Case Western Reserve University, Cleveland, Ohio, USA. | | Source | Arch Dermatol 2005 Apr; 141(4):467-73. | | MeSH | Administration, Topical
Adult
Aged
Aged, 80 and over
Aminoquinolines
Comparative Study
Confidence Intervals
Dose-Response Relationship, Drug
Double-Blind Method
Drug Administration Schedule
Female
Follow-Up Studies
Humans
Keratosis
Male
Middle Aged
Ointments
Precancerous Conditions
Probability
Reference Values
Research Support, Non-U.S. Gov't
Risk Assessment
Severity of Illness Index
Skin Neoplasms
Statistics, Nonparametric
Treatment Outcome
| | Abstract | OBJECTIVE: To evaluate the efficacy and safety of 5% imiquimod cream compared with vehicle in the treatment of actinic keratosis (AK).
DESIGN: Two phase 3 randomized, double-blind, parallel-group, vehicle-controlled studies.
SETTING: Twenty-six ambulatory care offices, including dermatologists in private practice or research centers.
PATIENTS: Four hundred ninety-two patients, 18 years and older, with 4 to 8 AK lesions in a 25-cm(2) treatment area on the face or the balding scalp were randomized; an additional 162 patients underwent screening but were ineligible.
INTERVENTIONS: Patients applied 5% imiquimod (Aldara) or vehicle cream to the treatment area once daily, 3 times per week, for 16 weeks, followed by an 8-week posttreatment period. MAIN OUTCOME
MEASUREMENTS: Complete clearance rate (proportion of patients at the 8-week posttreatment visit with no clinically visible AK lesions in the treatment area), partial clearance rate (proportion of patients at the 8-week posttreatment visit with a >/=75% reduction in the number of baseline AK lesions in the treatment area), and frequency and severity of adverse events and local skin reactions were measured.
RESULTS: Complete and partial clearance rates for imiquimod-treated patients (48.3% and 64.0%, respectively) were clinically and statistically significantly higher than for vehicle-treated patients (7.2% and 13.6%, respectively). The median percentage reduction of baseline lesions was 86.6% for the imiquimod-treated group and 14.3% for the vehicle-treated group.
CONCLUSION: The 5% imiquimod cream dosed 3 times weekly for 16 weeks is safe and effective for the treatment of AK. | | Language | eng | | Pub Type(s) | Clinical Trial
Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
| | PubMed ID | 15837864 |
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