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)
NCT ID: NCT00916006
Last Updated: 2015-04-02
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
269 participants
INTERVENTIONAL
2009-06-30
2009-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
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)
NCT00915551
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
NCT00942604
A Multi-center Study to Evaluate the Safety and Efficacy of PEP005 (Ingenol Mebutate) Gel, When Used to Treat Actinic Keratoses on Non-head Locations (Trunk and Extremities)
NCT00917306
A Multicenter Study to Evaluate the Safety and Efficacy of PEP005 Topical Gel When Used to Treat Actinic Keratoses on the Head (Face or Scalp)
NCT00700063
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
NCT00742391
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
PEP005 gel
PEP005 gel, 0.015% applied once daily for three consecutive days
PEP005 Gel
0.015%, three day treatment
Vehicle gel
Vehicle gel applied once daily for three consecutive days
Vehicle gel
Vehicle gel, three day treatment
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
PEP005 Gel
0.015%, three day treatment
Vehicle gel
Vehicle gel, three day treatment
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Peplin
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Eugene Bauer, MD
Role: STUDY_DIRECTOR
Chief Medical Officer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Dermatology Research Associates
Los Angeles, California, United States
Dermatology Specialists Inc
Oceanside, California, United States
Skin Surgery Medical Group Inc.
San Diego, California, United States
Conant Medical Group
San Francisco, California, United States
University of Miami, Skin Research Camp
Miami, Florida, United States
Atlanta Dermatology, Vein & Research Center, LLC
Alpharetta, Georgia, United States
Medaphase Inc
Newnan, Georgia, United States
Glazer Dermatology
Buffalo Grove, Illinois, United States
Dawes Fretein Clinical Research Group, LLC
Indianapolis, Indiana, United States
Pedia Research LLC
Owensboro, Kentucky, United States
Hamzavi Dermatology
Fort Gratiot, Michigan, United States
Minnesota Clinical Study Center
Fridley, Minnesota, United States
Wake Research Associates
Raleigh, North Carolina, United States
Dermatology Research Associates
Nashville, Tennessee, United States
J & S Studies, Inc.
College Station, Texas, United States
Dermatology Associates of Tyler
Tyler, Texas, United States
Center for Clinical Studies
Webster, Texas, United States
Dermatology Research Center, Inc.
Salt Lake City, Utah, United States
Virginia Clinical Research, Inc
Norfolk, Virginia, United States
Southderm Pty Ltd
Kogarah, New South Wales, Australia
St George Dematology and Skin Cancer Centre
Kogarah, New South Wales, Australia
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Related Links
Access external resources that provide additional context or updates about the study.
Food and Drug Authority
Therapeutic Goods Administration
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PEP005-016
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.