Open-Label Safety Study to Evaluate Imiquimod Cream, 5% for Large Areas of Actinic Keratosis

Completed · Phase 4

Conditions studied: Keratosis

In brief

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 purpose of this study is to evaluate the safety of one, two, or three cycles of imiquimod for the treatment of AK. The AK lesions treated can be in adjacent and nonadjacent areas of the head, torso, and extremities. The total surface area for the AK lesions must be greater than 25 cm2. The secondary objective is to evaluate the effectiveness of treatment with imiquimod in people with large surface areas of AK.

Key facts

Study ID

NCT00116649

Run by

Graceway Pharmaceuticals, LLC

People needed

551

Starts

2005-06-01

Expected to finish

2007-05-01

Last updated by the study team

2010-07-20

Who can join

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

You may qualify if…

• Are at least 18 years of age.
• Have greater than 25 cm2 total treatment area(s) containing at least 4 actinic keratosis lesions.

You may not qualify if…

• 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.

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — Encino, California, United States
• Study site — Los Angeles, California, United States
• Study site — Riverside, California, United States
• Study site — San Diego, California, United States
• Study site — Santa Monica, California, United States
• Study site — Denver, Colorado, United States
• Study site — New Britain, Connecticut, United States
• Study site — Coral Gables, Florida, United States
• Study site — Hollywood, Florida, United States
• Study site — Miami, Florida, United States
• Study site — West Palm Beach, Florida, United States
• Study site — Arlington Heights, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Metairie, Louisiana, United States
• Study site — Boston, Massachusetts, United States
• Study site — Chaska, Minnesota, United States
• Study site — Henderson, Nevada, United States
• Study site — Henderson, Nevada, United States
• Study site — Reno, Nevada, United States
• Study site — Reno, Nevada, United States
• Study site — New York, New York, United States
• Study site — High Point, North Carolina, United States
• Study site — Raleigh, North Carolina, United States
• Study site — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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