A Multicenter Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel When Used to Treat Actinic Keratoses (AKs) on the Non Head Locations
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)
1 other identifier
interventional
203
1 country
17
Brief Summary
The purpose of this study is to determine whether topical application of PEP005 is effective for the treatment of actinic keratoses.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jul 2009
Shorter than P25 for phase_3
17 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
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 19, 2009
CompletedFirst Posted
Study publicly available on registry
July 21, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedResults Posted
Study results publicly available
March 19, 2012
CompletedMarch 6, 2015
November 1, 2013
3 months
July 19, 2009
February 21, 2012
February 18, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Proportion of Patients With Partial Clearance of Actinic Keratoses (AK) Lesions
57 days
Study Arms (2)
PEP005 (ingenol mebutate) Gel
ACTIVE COMPARATORPEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
Vehicle gel
PLACEBO COMPARATORVehicle gel once daily for 2 consecutive days
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- to 8 AK lesions on non-head locations.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Peplinlead
Study Sites (17)
Burke Pharmaceutical Research
Hot Springs, Arizona, 71913, United States
Skin Surgery Medical Group Inc.
San Diego, California, 92117, United States
Atlanta Dermatology, Vein & Research Center, LLC
Alpharetta, Georgia, 30022, United States
Altman Dermatology Associates
Arlington Heights, Illinois, 60005, United States
Glazer Dermatology
Buffalo Grove, Illinois, 60089, United States
Deaconess Clinic Downtown
Evansville, Indiana, 47713, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46256, United States
Skin Specialists, PC
Omaha, Nebraska, 68144, United States
Karl G. Heine Dermatology
Henderson, Nevada, 89002, United States
Group Health Associates
Cincinnati, Ohio, 45220, United States
DermResearch, Inc.
Austin, Texas, 78759, United States
Suzanne Bruce and Associates, PA, The Center for Skin Research
Houston, Texas, 77056, United States
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, 78229, United States
Dermatology Associates of Tyler
Tyler, Texas, 75703, United States
Dermatology Research Center, Inc.
Salt Lake City, Utah, 84124, United States
The Education and Research Foundation
Lynchburg, Virginia, 24501, United States
Virginia Clinical Research, Inc
Norfolk, Virginia, 23507, United States
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
July 19, 2009
First Posted
July 21, 2009
Study Start
July 1, 2009
Primary Completion
October 1, 2009
Study Completion
October 1, 2009
Last Updated
March 6, 2015
Results First Posted
March 19, 2012
Record last verified: 2013-11