Overview

Safety and Effectiveness Study of Imiquimod Creams for the 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 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 pregnancy test (for women who are able to become pregnant).

- Willing to make frequent visits to the study center during the 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 (such as: 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.