Study to Assess the Safety and Efficacy of Imiquimod 5% Cream for the Treatment of Actinic Keratosis on the Arms and Hands

Completed · Phase 4

Conditions studied: Keratosis

In brief

The purpose of this study is to evaluate the safety and efficacy of imiquimod 5% cream compared to vehicle cream in the treatment of Actinic Keratosis (AK) on the arm and/or hand when the cream is applied once daily 2 days per week for 16 weeks.

Key facts

Study ID

NCT00115154

Run by

Graceway Pharmaceuticals, LLC

People needed

270

Starts

2005-05-01

Expected to finish

2006-09-01

Last updated by the study team

2007-02-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 18 years of age
• Have AK on arm or hand
• Discontinuation of sun tanning and the use of tanning beds
• Discontinuation of the use of moisturizers, body oils, over-the-counter retinol products and products containing alpha or beta hydroxy acid in the treatment and surrounding area
• Withholding of the use of sunscreen in the treatment area for 24 hours prior to all study visits and for 8 hours before applying study cream
• Postponement of the treatment of non-study AK lesions anywhere on the arm being treated until study participation is complete

You may not qualify if…

• Subjects must not have any evidence of systemic cancer or immunosuppression or other unstable health conditions
• Participation in another clinical study
• Have previously received treatment with imiquimod within the treatment area
• Have squamous cell carcinoma (SCC), basal cell carcinoma (BCC), or other malignancy in the treatment or surrounding area that requires treatment

Where it is running

• Study site — Tucson, Arizona, United States
• Study site — Vista, California, United States
• Study site — Atlanta, Georgia, United States
• Study site — Newnan, Georgia, United States
• Study site — Buffalo Grove, Illinois, United States
• Study site — Evansville, Indiana, United States
• Study site — Riverside Park, New Jersey, United States
• Study site — New York, New York, United States
• Study site — Rochester, New York, United States
• Study site — Greenville, North Carolina, United States
• Study site — Portland, Oregon, United States
• Study site — Providence, Rhode Island, United States
• Study site — Knoxville, Tennessee, United States
• Study site — Dallas, Texas, United States
• Study site — Houston, Texas, United States
• Study site — Virginia Beach, Virginia, United States
• Study site — Wenatchee, Washington, United States
• Study site — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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