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
Public ClinicalTrials.gov record NCT00742391. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multi-center, Randomized, Parallel Group, Double-blind, Vehicle-controlled Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel, 0.05% In Patients With Actinic Keratoses ON Non-head Locations (REGION-I)
Study identification
- NCT ID
- NCT00742391
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Peplin
- Industry
- Enrollment
- 255 participants
Conditions and interventions
Conditions
Interventions
- PEP005 (ingenol mebutate) Gel Drug
- Vehicle gel Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 31, 2008
- Primary completion
- Jan 31, 2009
- Completion
- Jan 31, 2009
- Last update posted
- Mar 5, 2015
2008 – 2009
United States locations
- U.S. sites
- 18
- U.S. states
- 13
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Omni Dermatology Research | Mesa | Arizona | 85206 | — |
| Colorado Medical Research Center | Denver | Colorado | 80210 | — |
| Advanced Dermatology and Cosmetic Research | Kissimmee | Florida | 34741 | — |
| Park Avenue Dermatology | Orange Park | Florida | 32073 | — |
| Advanced Dermatology & Cosmetic Surgery | Ormond Beach | Florida | 32174 | — |
| Medaphase Inc | Newnan | Georgia | 30263 | — |
| Gwinnett Clinical Research Centre | Snellville | Georgia | 30078-3250 | — |
| Dermatology Center of Indiana/Indiana Clinical Trials Center | Plainfield | Indiana | 46168 | — |
| Henry Ford Health Systems | Detroit | Michigan | 48202 | — |
| Karen S. Harkaway, MD. LLC | South Delran | New Jersey | 08075 | — |
| Academic Dermatology Associates | Albuquerque | New Mexico | 87106 | — |
| Dermatology Associates of Rochester | Rochester | New York | 14623 | — |
| University Hospitals Case Medical Center | Cleveland | Ohio | 44121 | — |
| Oregon Medical Research | Portland | Oregon | 97223 | — |
| Oregon Health and Science University | Portland | Oregon | 97239-4501 | — |
| Dermatology East | Germantown | Tennessee | 38138 | — |
| Rivergate Dermatology and Skin Care Center | Goodlettsville | Tennessee | 37072 | — |
| J & S Studies, Inc. | College Station | Texas | 77845 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00742391, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 5, 2015 · Synced Jul 22, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00742391 live on ClinicalTrials.gov.