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Open-Label Safety and Pharmacokinetic Study of AldaraTM (Imiquimod) Cream, 5% for One, Two, or Three Treatment Cycles to Surface Areas Greater Than 25 cm2 With Actinic Keratosis

Phase 4
18 Years
Not Enrolling

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Trial Information

Open-Label Safety and Pharmacokinetic Study of AldaraTM (Imiquimod) Cream, 5% for One, Two, or Three Treatment Cycles to Surface Areas Greater Than 25 cm2 With Actinic Keratosis

This was a Phase 4, open-label, single-arm, multicenter study in male and female subjects
aged 18 years or older with clinically diagnosed AK lesions, conducted at 31 investigational
sites in the United States.

This study assessed the safety of imiquimod as a treatment for AK applied in doses ranging
from one packet 12.5 mg) to 6 packets (75 mg) to either single or multiple body regions for
up to 3 cycles, depending upon treatment success and AK lesion recurrence. Eligible subjects
applied imiquimod 5% cream prior to normal sleeping hours 2 days per week to at least 4
clinically typical, visible, discrete, nonhypertrophic AK lesions in contiguous or
noncontiguous treatment areas totaling greater than 25 cm2 at baseline. Multiple treatment
areas could be exposed (i.e., head, torso and/or extremities), with the number of packets
determined by the investigator but not to exceed one packet for each 25 cm2 treatment area,
up to a maximum of 6 packets per dose. In each treatment cycle, dosing was to continue for
16 weeks (approximately 4 months), as instructed by the investigator, followed by a 2-month,
treatment-free follow-up period.

Inclusion Criteria:

- Are at least 18 years of age.

- Have greater than 25 cm2 total treatment area(s) containing at least 4 actinic
keratosis lesions.

Exclusion Criteria:

- 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: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants Who Experienced an Adverse Event

Outcome Description:

Adverse events that occurred between the first day of exposure to the study cream and study discharge were summarized. Adverse events - any untoward medical occurrence in a subject that is temporally related to protocol procedures, including the administration of a pharmaceutical product at any dose, but which does not necessarily have a causal relationship with the treatment.

Outcome Time Frame:

from first dose up to 18 months

Safety Issue:


Principal Investigator

Sharon Levy, MD

Investigator Role:

Study Director

Investigator Affiliation:

Graceway Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

June 2005

Completion Date:

May 2007

Related Keywords:

  • Keratosis
  • actinic keratosis lesions large head torso extremities
  • actinic keratosis
  • Keratosis
  • Keratosis, Actinic
  • Ichthyosis
  • Keratoacanthoma



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