Actinic Keratosis 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, 0.015% In Patients With Actinic Keratoses ON the Head (Face or Scalp) (REGION-IIa)
This Phase III study is designed to assess the efficacy and safety of PEP005 Gel, 0.015% when applied to an area of skin containing 4-8 AK lesions on the face or scalp.
Status | Completed |
Enrollment | 269 |
Est. completion date | September 2009 |
Est. primary completion date | September 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patient is male or female and at least 18 years of age - Female patients must be of either: - Non-childbearing potential, post-menopausal - Childbearing potential, provided there are negative serum and urine pregnancy test results prior to study treatment, to rule out pregnancy Exclusion Criteria: - Cosmetic or therapeutic procedures within 2 weeks and 2cm 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 the selected treatment area |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | Southderm Pty Ltd | Kogarah | New South Wales |
Australia | St George Dematology and Skin Cancer Centre | Kogarah | New South Wales |
United States | Atlanta Dermatology, Vein & Research Center, LLC | Alpharetta | Georgia |
United States | Glazer Dermatology | Buffalo Grove | Illinois |
United States | J & S Studies, Inc. | College Station | Texas |
United States | Hamzavi Dermatology | Fort Gratiot | Michigan |
United States | Minnesota Clinical Study Center | Fridley | Minnesota |
United States | Dawes Fretein Clinical Research Group, LLC | Indianapolis | Indiana |
United States | Dermatology Research Associates | Los Angeles | California |
United States | University of Miami, Skin Research Camp | Miami | Florida |
United States | Dermatology Research Associates | Nashville | Tennessee |
United States | Medaphase Inc | Newnan | Georgia |
United States | Virginia Clinical Research, Inc | Norfolk | Virginia |
United States | Dermatology Specialists Inc | Oceanside | California |
United States | Pedia Research LLC | Owensboro | Kentucky |
United States | Wake Research Associates | Raleigh | North Carolina |
United States | Dermatology Research Center, Inc. | Salt Lake City | Utah |
United States | Skin Surgery Medical Group Inc. | San Diego | California |
United States | Conant Medical Group | San Francisco | California |
United States | Dermatology Associates of Tyler | Tyler | Texas |
United States | Center for Clinical Studies | Webster | Texas |
Lead Sponsor | Collaborator |
---|---|
Peplin |
United States, Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patients With Complete Clearance of Actinic Keratosis (AK) Lesions. | Complete clearance rate of actinic keratosis (AK) lesions, defined as the proportion of patients with no clinically visible AK lesions in the selected treatment area. | 57 days | No |
Secondary | Patients With Partial Clearance of Actinic Keratosis (AK) | Patients with partial clearance defined as = 75% reduction in the number of actinic keratosis (AK) lesions identified at baseline in the treatment area | baseline and 57 days | No |
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