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

Completed · Phase 3 · Has a placebo group

Conditions studied: Actinic Keratosis

In brief

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.

Key facts

Study ID

NCT00603798

Run by

Graceway Pharmaceuticals, LLC

People needed

490

Starts

2008-01-01

Expected to finish

2008-07-01

Last updated by the study team

2010-06-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Encino, California, United States
• Study site — Vista, California, United States
• Study site — New Britain, Connecticut, United States
• Study site — New Haven, Connecticut, United States
• Study site — Coral Gables, Florida, United States
• Study site — West Palm Beach, Florida, United States
• Study site — Arlington Heights, Illinois, United States
• Study site — Champaign, Illinois, United States
• Study site — Carmel, Indiana, United States
• Study site — Evansville, Indiana, United States
• Study site — South Bend, Indiana, United States
• Study site — Louisville, Kentucky, United States
• Study site — Omaha, Nebraska, United States
• Study site — Reno, Nevada, United States
• Study site — Albuquerque, New Mexico, United States
• Study site — Portland, Oregon, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Nashville, Tennessee, United States
• Study site — Dallas, Texas, United States
• Study site — Houston, Texas, United States
• Study site — Houston, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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