Study to Assess the Safety and Efficacy of Imiquimod 5% Cream for the Treatment of Actinic Keratosis on the Arms and Hands
This study has been completed.
Sponsor:
Graceway Pharmaceuticals, LLC
Information provided by:
Graceway Pharmaceuticals, LLC
ClinicalTrials.gov Identifier:
NCT00115154
First received: June 21, 2005
Last updated: February 16, 2007
Last verified: February 2007
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Purpose
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 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
hystrix-like ichthyosis with deafness
lamellar ichthyosis
nonbullous congenital ichthyosiform erythroderma
Drug Information available for:
Imiquimod
U.S. FDA Resources
Further study details as provided by Graceway Pharmaceuticals, LLC:
Primary Outcome Measures:
- 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:
- The secondary objective is to evaluate the safety of treatment with imiquimod 5% cream in subjects with AK lesions on the upper extremities.
| Estimated Enrollment: | 270 |
| Study Start Date: | May 2005 |
| Estimated Study Completion Date: | September 2006 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00115154
Locations
| United States, Arizona | |
| Tucson, Arizona, United States, 85710 | |
| United States, California | |
| Vista, California, United States, 92083 | |
| United States, Georgia | |
| Atlanta, Georgia, United States, 30263 | |
| Newnan, Georgia, United States, 30263 | |
| United States, Illinois | |
| Buffalo Grove, Illinois, United States, 60089 | |
| United States, Indiana | |
| Evansville, Indiana, United States, 47713 | |
| United States, New Jersey | |
| Delran, New Jersey, United States, 08075 | |
| United States, New York | |
| New York, New York, United States, 10025 | |
| Rochester, New York, United States, 14623 | |
| United States, North Carolina | |
| Greenville, North Carolina, United States, 27834 | |
| United States, Oregon | |
| Portland, Oregon, United States, 97223 | |
| United States, Rhode Island | |
| Providence, Rhode Island, United States, 02903 | |
| United States, Tennessee | |
| Knoxville, Tennessee, United States, 37922 | |
| United States, Texas | |
| Dallas, Texas, United States, 75246 | |
| Houston, Texas, United States, 77030 | |
| United States, Virginia | |
| Virginia Beach, Virginia, United States, 23454 | |
| United States, Washington | |
| Wenatchee, Washington, United States, 98801 | |
| United States, Wisconsin | |
| Milwaukee, Wisconsin, United States, 53209 | |
Sponsors and Collaborators
Graceway Pharmaceuticals, LLC
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00115154 History of Changes |
| Other Study ID Numbers: | 1516-IMIQ |
| Study First Received: | June 21, 2005 |
| Last Updated: | February 16, 2007 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Graceway Pharmaceuticals, LLC:
|
Actinic Keratosis AK 3M Pharmaceuticals |
Aldara Imiquimod Actinic Keratosis (AK) |
Additional relevant MeSH terms:
|
Keratosis Keratosis, Actinic Ichthyosis Keratoacanthoma Skin Diseases Precancerous Conditions Neoplasms Skin Abnormalities Congenital Abnormalities |
Infant, Newborn, Diseases Imiquimod Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Interferon Inducers |
ClinicalTrials.gov processed this record on May 19, 2013