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)

ClinicalTrials.gov ID: NCT00915551

Public ClinicalTrials.gov record NCT00915551. 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.

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ClinicalTrials.gov public records Last synced Jul 22, 2026, 11:03 PM EDT

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-IIb)

Study identification

NCT ID: NCT00915551
Recruitment status: Completed
Study type: Interventional
Phase: Phase 3
Lead sponsor: Peplin; Industry
Enrollment: 278 participants

Conditions and interventions

Conditions

Actinic Keratosis

Interventions

PEP005 (Ingenol Mebutate) gel, 0.015% 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: May 31, 2009
Primary completion: Aug 31, 2009
Completion: Aug 31, 2009
Last update posted: Mar 5, 2015

2009

United States locations

U.S. sites: 19
U.S. states: 14
U.S. cities: 19

Facility	City	State	ZIP	Site status
Burke Pharmaceutical Research	Hot Springs	Arizona	71913	—
Center for Dermatology	Fremont	California	94538	—
North Florida Dermatology Associates, PA	Jacksonville	Florida	32204	—
Altman Dermatology Associates	Arlington Heights	Illinois	60005	—
Laser Skin Surgery Center of Indiana	Carmel	Indiana	46032	—
Deaconess Clinic, Inc	Evansville	Indiana	47713	—
The Indiana Clinical Trials Center, PC	Plainfield	Indiana	46168	—
Skin Specialists, PC	Omaha	Nebraska	—	—
Karl G. Heine Dermatology	Henderson	Nevada	89002	—
Academic Dermatology Associates	Albuquerque	New Mexico	87106	—
Mount Sinai School of Medicine	New York	New York	10029-6574	—
Dermatology Associates of Rochester, PC	Rochester	New York	14623	—
Dermatology, Laser Vein Specialists of the Carolinas	Charlotte	North Carolina	28207	—
Oregon Medical Research Center, PC	Portland	Oregon	97223	—
DermResearch, Inc.	Austin	Texas	78759	—
Suzanne Bruce and Associates, PA, The Center for Skin Research	Houston	Texas	77056	—
Progressive Clinical Research	San Antonio	Texas	78229	—
The Education and Research Foundation	Lynchburg	Virginia	24501	—
Premier Clinical Research	Spokane	Washington	99204	—

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 NCT00915551, 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

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The complete protocol, eligibility criteria, and contact information for NCT00915551 live on ClinicalTrials.gov.

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