Safety and Effectiveness Study of Imiquimod Creams for Treatment of Actinic Keratoses (AKs)

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Graceway Pharmaceuticals, LLC
• Treatments: Imiquimod

Criteria

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.