Vehicle-Controlled, Double-Blind Study to Assess the Safety and Efficacy of Imiquimod 5% Cream for the Treatment of Actinic Keratosis on the Upper Extremities
Phase 4
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Keratosis
Both
Keratosis
Trial Information
Vehicle-Controlled, Double-Blind Study to Assess the Safety and Efficacy of Imiquimod 5% Cream for the Treatment of Actinic Keratosis on the Upper Extremities
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Outcome Measure:
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.
Authority:
United States: Food and Drug Administration
Study ID:
1516-IMIQ
NCT ID:
NCT00115154
Start Date:
May 2005
Completion Date:
September 2006
Related Keywords:
- Keratosis
- Actinic Keratosis
- AK
- 3M Pharmaceuticals
- Aldara
- Imiquimod
- Actinic Keratosis (AK)
- Keratosis
- Keratosis, Actinic
- Ichthyosis
- Keratoacanthoma
Name | Location |
|---|---|
| Hinsdale, Illinois 60521 | |
| Albany, Georgia 31701 | |
| Phoenix, Arizona 85012 | |
| Fountain Valley, California 92708 | |
| Albany, New York 12208 | |
| Nashville, Tennessee 37203-1632 | |
| Austin, Texas 78705 | |
| Seattle, Washington 98195 | |
| McLean, Virginia 22101 | |
| Hackensack, New Jersey 07601 | |
| Charlotte, North Carolina | |
| Eugene, Oregon | |
| Milwaukee, Wisconsin | |
| Indianapolis, Indiana | |
| Providence, Rhode Island 02908 |
