Actinic keratosis (AK) is a skin condition that shows up on skin routinely exposed to the sun, such as the face, scalp, shoulders, chest, back, arms, and hands. The purpose of this study is to evaluate the safety of one, two, or three cycles of imiquimod for the treatment of AK. The AK lesions treated can be in adjacent and nonadjacent areas of the head, torso, and extremities. The total surface...
Date First Received: June 30, 2005
Last Updated: January 4, 2008
Verified by: Graceway Pharmaceuticals, LLC, January 2008
Clinical Trial Phase: Phase 4 | Start Date: June 2005
Overall Status: Completed
Estimated Enrollment: 500
Brief Summary
Official Title: “Open-Label Safety and Pharmacokinetic Study of AldaraTM (Imiquimod) Cream, 5% for One, Two, or Three Treatment Cycles to Surface Areas Greater Than 25 cm2 With Actinic Keratosis”
Condition Keyword(s):
Intervention(s):
Actinic keratosis (AK) is a skin condition that shows up on skin routinely exposed to the sun, such as the face, scalp, shoulders, chest, back, arms, and hands. The purpose of this study is to evaluate the safety of one, two, or three cycles of imiquimod for the treatment of AK. The AK lesions treated can be in adjacent and nonadjacent areas of the head, torso, and extremities. The total surface area for the AK lesions must be greater than 25 cm2. The secondary objective is to evaluate the effectiveness of treatment with imiquimod in people with large surface areas of AK.
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Study Primary Completion Date: June 2007
Intervention(s) in this Clinical Trial
- Drug: imiquimod cream
Outcome Measures for this Clinical Trial
Primary Measures
- To evaluate the safety of 1, 2, or 3 16-week cycles of imiquimod for the treatment of actinic keratosis lesions totaling greater than 25 square centimeters
Secondary Measures
- To evaluate the efficacy of treatment with imiquimod in this population of subjects with actinic keratosis
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Are at least 18 years of age.
- Have greater than 25 cm2 total treatment area(s) containing at least 4 actinic keratosis lesions.
Exclusion Criteria:
- Have any skin condition in the treatment area that may be made worse by treatment with imiquimod (e.g., rosacea, psoriasis, atopic dermatitis, eczema).
- Have received specific treatments/medications in the treatment area(s) within the designated time period prior to study treatment initiation.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Graceway Pharmaceuticals, LLC
Additional Information
Information obtained from ClinicalTrials.gov on September 05, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00116649
Study ID Number: 1520-IMIQ
ClinicalTrials.gov Identifier: NCT00116649
Health Authority: United States: Food and Drug Administration
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