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Sponsored by: |
Graceway Pharmaceuticals, LLC |
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Information provided by: | Graceway Pharmaceuticals, LLC |
ClinicalTrials.gov Identifier: | NCT00605176 |
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.
Condition | Intervention | Phase |
---|---|---|
Actinic Keratoses |
Drug: Imiquimod A Drug: Imiquimod B Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 480 |
Study Start Date: | January 2008 |
Study Completion Date: | July 2008 |
Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator |
Drug: Imiquimod A
cream, 250 mg/packet, applied daily
|
2: Active Comparator |
Drug: Imiquimod B
cream, 250 mg/packet, applied daily
|
3: Placebo Comparator |
Drug: Placebo
cream, 250 mg/packet, applied daily
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Sharon F Levy, MD | Graceway Pharmaceuticals, LLC |
Responsible Party: | Graceway Pharmaceuticals ( Vice President, Product Development, Clinical ) |
Study ID Numbers: | GW01-0702 / 0704 |
Study First Received: | January 16, 2008 |
Last Updated: | October 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00605176 |
Health Authority: | United States: Food and Drug Administration |
Actinic keratosis Skin disease |
Keratosis Skin Diseases Interferons Imiquimod Tylosis |
Interferon Inducers Immunologic Factors Antineoplastic Agents Therapeutic Uses |
Physiological Effects of Drugs Adjuvants, Immunologic Pharmacologic Actions |