NCT00917306

A Multi-center Study to Evaluate the Safety and Efficacy of PEP005 (Ingenol Mebutate) Gel, When Used to Treat Actinic Keratoses on Non-head Locations (Trunk and Extremities)

A Multi-center, Open-label Study to Evaluate the Safety and Efficacy of PEP005 (Ingenol Mebutate) Gel, 0.05% in Patients With Actinic Keratoses on Non-head Locations (Trunk and Extremities)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Peplin · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The open label study is designed to assess the safety and efficacy of 0.05% PEP005 Gel when applied to an area of skin containing 4-8 AK lesions on non-head locations.

Conditions

• Actinic Keratosis

Interventions

Type	Name	Description
DRUG	PEP005 Gel	0.05% two day treatment

Timeline

• Start date: 2009-06-01
• Primary completion: 2009-09-01
• Completion: 2009-09-01
• First posted: 2009-06-10
• Last updated: 2015-04-15

Locations

11 sites across 2 countries: United States, Australia