Know Cancer

forgot password

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

Phase 3
18 Years
Not Enrolling
Actinic Keratoses

Thank you

Trial Information

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

This was a randomized, double-blind, multicenter, placebo-controlled study 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 AKs of the face or balding scalp. Subjects
were scheduled for a total of 9 visits (1 prestudy screening visit and 8 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 2 weeks of
daily treatment followed by 2 weeks of no treatment, and the second treatment cycle
consisted of an additional 2 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 investigator.

The duration of each subject's study participation was approximately 18 weeks, including a
4-week maximum screening period and a 14-week study period.

Inclusion Criteria:

- In good general health

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

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

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

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 (e.g., 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, Caregiver, 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 14 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 14 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:

GW01-0702 / 0704



Start Date:

January 2008

Completion Date:

July 2008

Related Keywords:

  • Actinic Keratoses
  • Actinic keratosis
  • Skin disease
  • Keratosis
  • Keratosis, Actinic



Hinsdale, Illinois  60521
Bettendorf, Iowa  52722
Albany, Georgia  31701
Fountain Valley, California  92708
Miami, Florida  33176
Albany, New York  12208
Nashville, Tennessee  37203-1632
Austin, Texas  78705
McLean, Virginia  22101
Kansas City, Kansas  66160
Metairie, Louisiana  70006
Charlotte, North Carolina  
Eugene, Oregon  
Las Vegas, Nevada  89109
Salt Lake City, Utah  84112
Coeur D'alene, Idaho  83814