Trials / Completed
CompletedNCT00916006
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 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)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 269 (actual)
- Sponsor
- Peplin · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PEP005 Gel | 0.015%, three day treatment |
| DRUG | Vehicle gel | Vehicle gel, three day treatment |
Timeline
- Start date
- 2009-06-01
- Primary completion
- 2009-09-01
- Completion
- 2009-09-01
- First posted
- 2009-06-08
- Last updated
- 2015-04-02
- Results posted
- 2012-03-21
Locations
21 sites across 2 countries: United States, Australia
Source: ClinicalTrials.gov record NCT00916006. Inclusion in this directory is not an endorsement.