NCT00375739

Study to Determine the Safety of PEP005 0.025% and 0.05% Topical Gel in Patients With Actinic Keratoses

A Multi-center, Randomized, Double-blind, Double-dummy, Vehicle-controlled Sequential Cohort Study to Determine the Safety PEP005 0.025% and 0.05% Topical Gel in Patients With Actinic Keratoses.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (planned)
• Sponsor: Peplin · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether topical application of PEP005 is safe for the treatment of actinic keratoses.

Detailed description

Actinic keratoses (AK) is a common skin condition characterized by rough, scaly patches or sores on the top layer of the skin which if left untreated can progress to skin cancer. Current treatments can cause scarring and hypopigmentation, be inconvenient, or require long treatment duration. Non-invasive alternative therapy for treatment of AK lesions is thus being researched.

Conditions

• Actinic Keratosis

Interventions

Type	Name	Description
DRUG	PEP005

Timeline

• Start date: 2006-09-01
• Primary completion: 2007-06-01
• Completion: 2007-06-01
• First posted: 2006-09-13
• Last updated: 2016-01-28

Locations

24 sites across 1 country: United States