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NCT00916006 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study of Actinic Keratosis, sponsored by Peplin.
- Completed
- Registry status
- Phase 3
- Development phase
- 269
- Enrollment target
- 20
- Study locations
NCT00916006: Completed Phase 3 study of Actinic Keratosis, sponsored by Peplin.
NCT00916006 is a Phase 3 study of Actinic Keratosis that has completed, run by Peplin. The registered enrollment target is 269 participants, above the 172-participant average among 16 other Actinic Keratosis trials with a reported enrollment target (56% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00916006, a Phase 3 study of Actinic Keratosis, has completed, sponsored by Peplin.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 269 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
Complete clearance rate of actinic keratosis (AK) lesions, defined as the proportion of patients with no clinically visible AK lesions in the selected treatment area.
Conditions Studied
Interventions
- DRUG Vehicle gel
- DRUG PEP005 Gel
Study Locations (20)
California
- Dermatology Research Associates - Los Angeles
- Dermatology Specialists Inc - Oceanside
- Skin Surgery Medical Group Inc. - San Diego
- Conant Medical Group - San Francisco
Texas
- J & S Studies, Inc. - College Station
- Dermatology Associates of Tyler - Tyler
- Center for Clinical Studies - Webster
Georgia
- Atlanta Dermatology, Vein & Research Center, LLC - Alpharetta
- Medaphase Inc - Newnan
Florida
- University of Miami, Skin Research Camp - Miami
Illinois
- Glazer Dermatology - Buffalo Grove
Indiana
- Dawes Fretein Clinical Research Group, LLC - Indianapolis
Kentucky
- Pedia Research LLC - Owensboro
Michigan
- Hamzavi Dermatology - Fort Gratiot
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 269 participants |
| Start Date | 2009-06 |
| Est. Completion | 2009-09 |
| Phase | Phase 3 |
What the finished NCT00916006 record still lists
NCT00916006 is an interventional study that assigns participants to a tested intervention. The registered 269 participants enrollment target is mid-sized for trials with a published cap, above the 172-participant average among 16 other Actinic Keratosis trials with a reported enrollment target (56% higher).
The record links to 1 condition, with Actinic Keratosis appearing as the primary indexed condition, and to 2 interventions - of which Vehicle gel is the first listed.
NCT00916006 names 20 study sites across 14 states, led by California, Texas, Georgia.
Frequently Asked Questions
What is clinical trial NCT00916006 about?
NCT00916006 is a clinical study titled "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)". 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.
What is the current status of trial NCT00916006?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 269 participants. The study started on 2009-06. Estimated completion is 2009-09.
What conditions does trial NCT00916006 study?
This clinical trial studies the following conditions: Actinic Keratosis.
What interventions are being tested in trial NCT00916006?
The interventions under investigation include: Vehicle gel (DRUG), PEP005 Gel (DRUG).
Who is sponsoring clinical trial NCT00916006?
This trial is sponsored by Peplin, which has 19 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00916006 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Actinic Keratosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00916006's enrollment target sits among peer trials
269 4th of 16 higher than 13 of 16 other Actinic Keratosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Actinic Keratosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Face and Scalp
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-
Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Upper Extremities
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-
Metvix PDT Versus Vehicle PDT With Aktilite CL128 Lamp in Patients With Actinic Keratosis on the Face and Scalp
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-
Efficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis on Face or Chest Including 12-month Follow-up
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-
Efficacy and Safety of Ingenol Mebutate Gel for Actinic Keratosis Applied on Large Area on Face, Scalp or Chest
COMPLETED · Phase 3
-
A Study of Equivalence of Generic Ingenol Mebutate Gel 0.05% and Picato Gel 0.05% in Subjects With Actinic Keratosis
COMPLETED · Phase 3
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