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A Phase 3, Randomized, Double-blinded, Placebo-controlled, Multicenter, Efficacy and Safety Study of Six Weeks of Treatment With Imiquimod Creams for Actinic Keratoses

Phase 3
18 Years
Not Enrolling
Actinic Keratosis

Thank you

Trial Information

A Phase 3, Randomized, Double-blinded, Placebo-controlled, Multicenter, Efficacy and Safety Study of Six Weeks of Treatment With Imiquimod Creams for Actinic Keratoses

These were a randomized, double-blind, multicenter, placebo-controlled studies that compared
the efficacy and safety of 2.5% imiquimod cream and 3.75% imiquimod cream with that of
placebo in the treatment of typical visible or palpable AK of the face or balding scalp.
Subjects were scheduled for a total of 11 visits (1 prestudy screening visit and 10 on-study
visits). Subjects determined to be eligible during the screening phase were randomized in a
1:1:1 ratio to 2.5% imiquimod cream, 3.75% imiquimod cream, or placebo cream. The creams
were applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks
of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle
consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
The investigator selected the treatment area for the study (either the entire face or the
entire balding scalp, but not both). Subjects applied a thin layer of cream to the
treatment area (up to 2 packets, or 500 mg of product, per application), avoiding the
periocular areas, lips, and nares. Study medication was applied prior to normal sleeping
hours and removed approximately 8 hours later with mild soap and water. Ears were excluded
from both assessment and treatment. Rest periods from daily treatment were instituted by
the investigator as needed to manage local skin reactions (LSRs) or application site
reactions, with resumption of treatment upon adequate resolution as determined by the

The duration of each subject's study participation was approximately 21 weeks, including a
4-week maximum screening period and a 17-week study period. At the End of Study (EOS)
visit, eligible subjects may have been invited to participate in a separate study evaluating
AK recurrence.

Inclusion Criteria:

- In good general health.

- Have 5 to 20 AKs on the face or balding scalp.

- Negative pregnancy test (for women who are able to become pregnant).

- Willing to make frequent visits to the study center during the treatment and
follow-up periods.

Exclusion Criteria:

- Women who are pregnant, lactating or planning to become pregnant during the study.

- Have had a medical event within 90 days of the first visit (such as: stroke, heart

- Have any skin condition in the treatment area that may be made worse by treatment
with imiquimod (such as: rosacea, psoriasis, atopic dermatitis, eczema).

- Have received specific treatments/medications in the treatment area(s) within the
designated time period prior to study treatment initiation.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Number of Participants With Complete Clearance of AK Lesions

Outcome Description:

Subject status with respect to complete clearance of AK lesions at End of Study (EOS), ie, the Week 17 visit. Complete clearance was defined as the absence of clinically visible or palpable AK lesions in the treatment area. All lesions within the identified treatment area were included in the count, even if the lesion was a new lesion or "subclinical" lesion that had not been identified at Baseline.

Outcome Time Frame:

End of Study the Week 17 visit

Safety Issue:


Principal Investigator

Sharon F Levy, MD

Investigator Role:

Study Director

Investigator Affiliation:

Graceway Pharmaceuticals


United States: Food and Drug Administration

Study ID:

GW01-0703 / 0705



Start Date:

January 2008

Completion Date:

July 2008

Related Keywords:

  • Actinic Keratosis
  • Actinic keratosis
  • Dermatologic disease
  • Keratosis
  • Keratosis, Actinic



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