A Multi-center Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel, When Used to Treat Actinic Keratoses on the Head (Face or Scalp)
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)
1 other identifier
interventional
269
2 countries
21
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2009
Shorter than P25 for phase_3
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 4, 2009
CompletedFirst Posted
Study publicly available on registry
June 8, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedResults Posted
Study results publicly available
March 21, 2012
CompletedApril 2, 2015
March 1, 2015
3 months
June 4, 2009
February 21, 2012
March 13, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Patients With Partial Clearance of Actinic Keratosis (AK)
baseline and 57 days
Study Arms (2)
PEP005 gel
EXPERIMENTALPEP005 gel, 0.015% applied once daily for three consecutive days
Vehicle gel
PLACEBO COMPARATORVehicle gel applied once daily for three consecutive days
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Peplinlead
Study Sites (21)
Dermatology Research Associates
Los Angeles, California, 90045, United States
Dermatology Specialists Inc
Oceanside, California, 92056, United States
Skin Surgery Medical Group Inc.
San Diego, California, 92117, United States
Conant Medical Group
San Francisco, California, 94114, United States
University of Miami, Skin Research Camp
Miami, Florida, 33136, United States
Atlanta Dermatology, Vein & Research Center, LLC
Alpharetta, Georgia, 30022, United States
Medaphase Inc
Newnan, Georgia, 30263, United States
Glazer Dermatology
Buffalo Grove, Illinois, 60089, United States
Dawes Fretein Clinical Research Group, LLC
Indianapolis, Indiana, 46256, United States
Pedia Research LLC
Owensboro, Kentucky, 42301, United States
Hamzavi Dermatology
Fort Gratiot, Michigan, 48059, United States
Minnesota Clinical Study Center
Fridley, Minnesota, 55432, United States
Wake Research Associates
Raleigh, North Carolina, 27612, United States
Dermatology Research Associates
Nashville, Tennessee, 37203, United States
J & S Studies, Inc.
College Station, Texas, 77845, United States
Dermatology Associates of Tyler
Tyler, Texas, 75703, United States
Center for Clinical Studies
Webster, Texas, 77598, United States
Dermatology Research Center, Inc.
Salt Lake City, Utah, 84124, United States
Virginia Clinical Research, Inc
Norfolk, Virginia, 23507, United States
Southderm Pty Ltd
Kogarah, New South Wales, 2217, Australia
St George Dematology and Skin Cancer Centre
Kogarah, New South Wales, 2217, Australia
Related Publications (1)
Lebwohl M, Swanson N, Anderson LL, Melgaard A, Xu Z, Berman B. Ingenol mebutate gel for actinic keratosis. N Engl J Med. 2012 Mar 15;366(11):1010-9. doi: 10.1056/NEJMoa1111170.
PMID: 22417254DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Torsten Skov
- Organization
- LEO Pharma
Study Officials
- STUDY DIRECTOR
Eugene Bauer, MD
Chief Medical Officer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 4, 2009
First Posted
June 8, 2009
Study Start
June 1, 2009
Primary Completion
September 1, 2009
Study Completion
September 1, 2009
Last Updated
April 2, 2015
Results First Posted
March 21, 2012
Record last verified: 2015-03