Format

Send to

Choose Destination
See comment in PubMed Commons below
Arch Dermatol. 2005 Apr;141(4):467-73.

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 information

1
Department of Dermatology, University Hospitals of Cleveland, Case Western Reserve University, Cleveland, Ohio, USA.

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.

PMID:
15837864
DOI:
10.1001/archderm.141.4.467
[Indexed for MEDLINE]
PubMed Commons home

PubMed Commons

0 comments
How to join PubMed Commons

    Supplemental Content

    Full text links

    Icon for Silverchair Information Systems
    Loading ...
    Support Center