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)
Public ClinicalTrials.gov record NCT00916006. 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, 0.015% In Patients With Actinic Keratoses ON the Head (Face or Scalp) (REGION-IIa)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00916006
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 269 participants
Conditions and interventions
Conditions
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
- Jun 2009 (Type not available)
- Primary completion
- Sep 2009 (Actual)
- Completion
- Sep 2009 (Actual)
- Last update posted
- Apr 2, 2015
2009
United States locations
- U.S. sites
- 19
- U.S. states
- 13
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Dermatology Research Associates | Los Angeles | California | 90045 | — |
| Dermatology Specialists Inc | Oceanside | California | 92056 | — |
| Skin Surgery Medical Group Inc. | San Diego | California | 92117 | — |
| Conant Medical Group | San Francisco | California | 94114 | — |
| University of Miami, Skin Research Camp | Miami | Florida | 33136 | — |
| Atlanta Dermatology, Vein & Research Center, LLC | Alpharetta | Georgia | 30022 | — |
| Medaphase Inc | Newnan | Georgia | 30263 | — |
| Glazer Dermatology | Buffalo Grove | Illinois | 60089 | — |
| Dawes Fretein Clinical Research Group, LLC | Indianapolis | Indiana | 46256 | — |
| Pedia Research LLC | Owensboro | Kentucky | 42301 | — |
| Hamzavi Dermatology | Fort Gratiot | Michigan | 48059 | — |
| Minnesota Clinical Study Center | Fridley | Minnesota | 55432 | — |
| Wake Research Associates | Raleigh | North Carolina | 27612 | — |
| Dermatology Research Associates | Nashville | Tennessee | 37203 | — |
| J & S Studies, Inc. | College Station | Texas | 77845 | — |
| Dermatology Associates of Tyler | Tyler | Texas | 75703 | — |
| Center for Clinical Studies | Webster | Texas | 77598 | — |
| Dermatology Research Center, Inc. | Salt Lake City | Utah | 84124 | — |
| Virginia Clinical Research, Inc | Norfolk | Virginia | 23507 | — |
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 NCT00916006, 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 Apr 2, 2015 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00916006 live on ClinicalTrials.gov.