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A Phase 3b Randomized, Double-blinded, Placebo-controlled, Multicenter, Efficacy and Safety Study of Imiquimod Cream Following Cryosurgery for the Treatment of Actinic Keratoses

Phase 3
18 Years
Not Enrolling
Actinic Keratosis

Thank you

Trial Information

A Phase 3b Randomized, Double-blinded, Placebo-controlled, Multicenter, Efficacy and Safety Study of Imiquimod Cream Following Cryosurgery for the Treatment of Actinic Keratoses

In this multicenter, randomized, double-blind, placebo-controlled study, the efficacy and
safety of imiquimod 3.75% cream following cryosurgery to treat clinically typical visible or
palpable AK lesions on the face was compared with that of placebo cream. Based on a 1:1
randomization, approximately 120 subjects applied imiquimod 3.75% cream daily (up to 500 mg
cream daily [18.75 mg imiquimod]) and approximately 120 subjects applied placebo cream
daily during two 2-week periods (Cycle 1 and Cycle 2) separated by 2 weeks of no treatment.
Subjects visited the clinic 9 times—1 screening/cryosurgery visit (additional visits might
be needed during the screening period to assess healing from the cryosurgery), 4 treatment
visits(treatment initiation at Weeks 0 and 4 and treatment follow-up at the end of Weeks 2
and 6), and 4 posttreatment visits (4, 8, 14, and 20 weeks after the last administration of
study treatment at the end of Week 6). The total study duration for a subject, including a
2-week screening period, was up to 28 weeks.

Prior to cryosurgery, subjects had to have ≥10 clinically typical visible or palpable AK
lesions in an area that exceeded 25 cm^2 on the face to be eligible for participation in the
study. At screening, a minimum of 5 visible lesions were not treated with cryosurgery, and 5
to 14 visible lesions were treated with cryosurgery. Subjects had to have at least 5 AK
lesions after the skin healed sufficiently from the cryosurgery to be eligible for
randomization to either imiquimod 3.75% or placebo cream. Subjects applied up to 2 packets
of study cream (500 mg total) as a thin layer to the entire face, avoiding the periocular
areas, lips, and nares; ears were excluded from both assessment and treatment. Study cream
was applied prior to normal sleeping hours and removed approximately 8 hours later with mild
soap and water. Rest periods from daily treatment could be approved by the investigator as
needed, with treatment resumption at the investigator's discretion.

Inclusion Criteria:

- In good general health

- Negative urine pregnancy test (for women of child-bearing potential) and agree to use
an approved method of birth control while enrolled in the study.

- Prior to cryosurgery, have ≥ 10 clinically typical (visible or palpable) AKs in an
area that exceeds 25 cm2 on the face.

- Must have had cryosurgery on 5 to 14 AKs on the face after giving informed consent
and prior to receiving study medication. Lesions previously treated with cryosurgery
must be healed sufficiently prior to randomization to study cream.

- Following cryosurgery, have ≥ 5 clinically typical (visible or palpable) AKs in an
area that exceeds 25 cm2 on the face that are suitable for treatment with the study

Exclusion Criteria:

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

- Had a medical event within 90 days of the visit (e.g., stroke, heart attack, etc.).

- 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 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:

Change From Baseline in Percentage of Lesion Count

Outcome Description:

The primary efficacy endpoint was a comparison between the active and placebo treatment groups of percent change from baseline in the total AK lesion count at Week 26. All AK lesions on the face were included in the analysis—treated and untreated AK lesions at baseline (defined as the AK lesion count just prior to cryosurgery) and new lesions that appeared post-baseline.

Outcome Time Frame:

Week 26

Safety Issue:


Principal Investigator

Sharon Levy, MD

Investigator Role:

Study Director

Investigator Affiliation:

Graceway Pharmaceuticals, LLC


United States: Food and Drug Administration

Study ID:




Start Date:

May 2009

Completion Date:

February 2010

Related Keywords:

  • Actinic Keratosis
  • actinic keratosis
  • skin disease
  • Keratosis
  • Keratosis, Actinic



Evanston Northwestern HealthcareEvanston, Illinois  60201
Wake Forest Univ School of MedicineWinston Salem, North Carolina  27157-1082
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Oregon Medical Research CenterPortland, Oregon  97223
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Palm Beach DermatologyWest Palm Beach, Florida  33401
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Academic Dermatology AssociationAlbuquerque, New Mexico  87106
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DermResearch Inc.Austin, Texas  78759
Dermatology Treatment and Research CenterDallas, Texas  75230