Study to Assess the Safety and Efficacy of Imiquimod 5% Cream for the Treatment of Actinic Keratosis on the Arms and Hands
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00115154 |
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Recruitment Status :
Completed
First Posted : June 22, 2005
Last Update Posted : February 19, 2007
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Sponsor:
Graceway Pharmaceuticals, LLC
Information provided by:
Graceway Pharmaceuticals, LLC
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Keratosis | Drug: Aldara (imiquimod) cream, 5% | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Enrollment : | 270 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double |
| 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 |
| Study Start Date : | May 2005 |
| Study Completion Date : | September 2006 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Imiquimod
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.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
| ClinicalTrials.gov Identifier: | NCT00115154 |
| Other Study ID Numbers: |
1516-IMIQ |
| First Posted: | June 22, 2005 Key Record Dates |
| Last Update Posted: | February 19, 2007 |
| Last Verified: | February 2007 |
Keywords provided by Graceway Pharmaceuticals, LLC:
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Actinic Keratosis AK 3M Pharmaceuticals |
Aldara Imiquimod Actinic Keratosis (AK) |
Additional relevant MeSH terms:
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Keratosis, Actinic Keratosis Skin Diseases Precancerous Conditions Neoplasms Imiquimod |
Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents Interferon Inducers |