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.

Condition	Intervention	Phase
Keratosis	Drug: Aldara (imiquimod) cream, 5%	Phase IV

Further Study Details: 

Primary Outcomes: The primary objective of this study is to evaluate the efficacy of imiquimod 5% cream compared to vehicle cream in the treatment of AK on the upper extremities when the cream is applied once daily 2 days per week for 16 weeks.
Secondary Outcomes: The secondary objective is to evaluate the safety of treatment with imiquimod 5% cream in subjects with AK lesions on the upper extremities.
Expected Total Enrollment:  270

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

• 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 nonstudy AK lesions anywhere on the arm being treated until study participation is complete

Exclusion Criteria:

• 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

Please refer to this study by ClinicalTrials.gov identifier  NCT00115154

North Carolina
      Charles Philips, MD, Greenville,  North Carolina,  27834,  United States; Recruiting

Study ID Numbers:  1516-IMIQ
Record last reviewed:  June 2005
Last Updated:  June 30, 2005
Record first received:  June 21, 2005
ClinicalTrials.gov Identifier:  NCT00115154
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-07-05