Actinic Keratoses Clinical Trial
Official title:
A Multi-center, Randomized, Parallel Group, Double-blind, Vehicle-controlled Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel, 0.05%, In Patients With Actinic Keratoses on Non-head Locations (REGION-Ib)
Verified date | November 2013 |
Source | Peplin |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The purpose of this study is to determine whether topical application of PEP005 is effective for the treatment of actinic keratoses.
Status | Completed |
Enrollment | 203 |
Est. completion date | October 2009 |
Est. primary completion date | October 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Must be male or female and at least 18 years of age. - Female patients must be of: - Non-childbearing potential; - Childbearing potential, provided negative serum and urine pregnancy test and using effective contraception. - 4 to 8 AK lesions on non-head locations. Exclusion Criteria: - Cosmetic or therapeutic procedures within 2 weeks and within 2 cm of the selected treatment area. - Treatment with immunomodulators, or interferon/ interferon inducers or systemic medications that suppress the immune system within 4 weeks. - Treatment with 5-FU, imiquimod, diclofenac, or photodynamic therapy within 8 weeks and 2 cm of treatment area |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Atlanta Dermatology, Vein & Research Center, LLC | Alpharetta | Georgia |
United States | Altman Dermatology Associates | Arlington Heights | Illinois |
United States | DermResearch, Inc. | Austin | Texas |
United States | Glazer Dermatology | Buffalo Grove | Illinois |
United States | Group Health Associates | Cincinnati | Ohio |
United States | Deaconess Clinic Downtown | Evansville | Indiana |
United States | Karl G. Heine Dermatology | Henderson | Nevada |
United States | Burke Pharmaceutical Research | Hot Springs | Arizona |
United States | Suzanne Bruce and Associates, PA, The Center for Skin Research | Houston | Texas |
United States | Dawes Fretzin Clinical Research Group, LLC | Indianapolis | Indiana |
United States | The Education and Research Foundation | Lynchburg | Virginia |
United States | Virginia Clinical Research, Inc | Norfolk | Virginia |
United States | Skin Specialists, PC | Omaha | Nebraska |
United States | Dermatology Research Center, Inc. | Salt Lake City | Utah |
United States | Dermatology Clinical Research Center of San Antonio | San Antonio | Texas |
United States | Skin Surgery Medical Group Inc. | San Diego | California |
United States | Dermatology Associates of Tyler | Tyler | Texas |
Lead Sponsor | Collaborator |
---|---|
Peplin |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of Patients With Complete Clearance of Actinic Keratoses (AK) Lesions | Proportion of Patients with Complete Clearance of the treatment field defined as no clinically visible Actinic Keratoses (AK) lesions in the selected treatment area | 57 days | No |
Secondary | Proportion of Patients With Partial Clearance of Actinic Keratoses (AK) Lesions | Proportion of patients with Partial Clearance defined as = 75 % reduction in the number of Actinic Keratoses (AK) lesions identified at baseline in the treatment area | 57 days | No |
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