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

Phase 4

Completed

• Conditions: Keratosis

• Registration Number: NCT00115154
• Lead Sponsor: Graceway Pharmaceuticals, LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2005-06-21
• Study First Submitted QC: 2005-06-21
• Study First Posted: 2005-06-22
• Study Completion: 2006-09
• Status Verified: 2007-02
• Last Update Submitted: 2007-02-16
• Last Update Posted: 2007-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 270

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 non-study 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
The secondary objective is to evaluate the safety of treatment with imiquimod 5% cream in subjects with AK lesions on the upper extremities.