Official Title: “A Phase 3, Randomized, Double-Blinded, Placebo-Controlled, Multicenter, Efficacy and Safety Study of Four Weeks of Treatment With Imiquimod Creams for Actinic Keratoses”

The purpose of this study is to determine whether imiquimod creams are effective in treating Actinic Keratoses when applied to the face or balding scalp.

Actinic keratosis (AK) is a skin condition that shows up on skin routinely exposed to the sun, such as the face, scalp, shoulders, chest, back, arms, and hands. The active ingredient contained in the study cream for this study is the same as that of the approved product Aldara, which has been shown to be safe and effective for the treatment of AKs.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: July 2008

Intervention(s) in this Clinical Trial

• Drug: Imiquimod A
  • cream, 250 mg/packet, applied daily
• Drug: Imiquimod B
  • cream, 250 mg/packet, applied daily
• Drug: Placebo
  • cream, 250 mg/packet, applied daily

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
• Active Comparator: 2
• Placebo Comparator: 3

Primary Measures

• Complete clearance rate
  • Time Frame: End of Study
    Safety Issue?: No

Secondary Measures

• Partial clearance rate
  • Time Frame: End of Study
    Safety Issue?: No
• AK counts and change from baseline
  • Time Frame: At all visits
    Safety Issue?: No
• Safety variables: adverse events and local skin reactions
  • Time Frame: At all visits
    Safety Issue?: Yes

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 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 attack).
• 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Graceway Pharmaceuticals, LLC

Overall Clinical Trial Officials and Contacts

Sharon F Levy, MD Study Director Graceway Pharmaceuticals  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00605176

Study ID Number: GW01-0702 / 0704

ClinicalTrials.gov Identifier: NCT00605176

Health Authority: United States: Food and Drug Administration