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Completed Phase 3 Interventional Results available

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.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 9:23 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)

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

Conditions and interventions

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
Mar 6, 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 6, 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 NCT00915551 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →