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

Graceway Pharmaceuticals

Status and phase

Completed

Phase 4

Conditions

Keratosis

Treatments

Drug: Aldara (imiquimod) cream, 5%

Study type

Interventional

Funder types

Industry

Identifiers

NCT00115154

1516-IMIQ

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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