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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00916006
The ClinicalTrials.gov registry entry for NCT00916006 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 269 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 172-participant average among 16 other Actinic Keratosis trials with a reported enrollment target (56% higher). The listed sponsor is Peplin, which has 19 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 14 distinct geographic areas - top geographies include 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
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-
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-
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-
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-
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Read our methodology - how this data is sourced, computed, and verified.
Related
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