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-IIb)
1 other identifier
interventional
278
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 16, 2012
CompletedMarch 6, 2015
November 1, 2013
3 months
June 4, 2009
February 21, 2012
February 18, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Complete Clearance of Actinic Keratoses (AK) Lesions
Complete clearance of the treatment field
baseline and 57 days
Secondary Outcomes (1)
Partial Clearance of Actinic Keratoses (AK)
baseline and 57 days
Study Arms (2)
PEP005 (Ingenol Mebutate) gel
EXPERIMENTALVehicle gel
PLACEBO COMPARATORInterventions
once daily for 3 consecutive days
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)
Burke Pharmaceutical Research
Hot Springs, Arizona, 71913, United States
Center for Dermatology
Fremont, California, 94538, United States
North Florida Dermatology Associates, PA
Jacksonville, Florida, 32204, United States
Altman Dermatology Associates
Arlington Heights, Illinois, 60005, United States
Laser Skin Surgery Center of Indiana
Carmel, Indiana, 46032, United States
Deaconess Clinic, Inc
Evansville, Indiana, 47713, United States
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, 46168, United States
Skin Specialists, PC
Omaha, Nebraska, United States
Karl G. Heine Dermatology
Henderson, Nevada, 89002, United States
Academic Dermatology Associates
Albuquerque, New Mexico, 87106, United States
Mount Sinai School of Medicine
New York, New York, 10029-6574, United States
Dermatology Associates of Rochester, PC
Rochester, New York, 14623, United States
Dermatology, Laser Vein Specialists of the Carolinas
Charlotte, North Carolina, 28207, United States
Oregon Medical Research Center, PC
Portland, Oregon, 97223, United States
DermResearch, Inc.
Austin, Texas, 78759, United States
Suzanne Bruce and Associates, PA, The Center for Skin Research
Houston, Texas, 77056, United States
Progressive Clinical Research
San Antonio, Texas, 78229, United States
The Education and Research Foundation
Lynchburg, Virginia, 24501, United States
Premier Clinical Research
Spokane, Washington, 99204, United States
The Skin Centre
Benowa, Queensland, 4217, Australia
South East Dermatology, Belmont Specialist Centre
Carina Heights, Queensland, 4152, 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)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Torsten Skov
- Organization
- LEO Pharma
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
March 6, 2015
Results First Posted
March 16, 2012
Record last verified: 2013-11