NCT00915551

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-IIb)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 278 (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

• Actinic Keratosis

Interventions

Type	Name	Description
DRUG	PEP005 (Ingenol Mebutate) gel, 0.015%	once daily for 3 consecutive days
DRUG	Vehicle Gel	once daily for 3 consecutive days

Timeline

• Start date: 2009-06-01
• Primary completion: 2009-09-01
• Completion: 2009-09-01
• First posted: 2009-06-08
• Last updated: 2015-03-06
• Results posted: 2012-03-16

Locations

21 sites across 2 countries: United States, Australia