NCT00427050

A Study to Determine the Optimal Tolerated Regime and Safety of PEP005 Topical Gel

An Open-label, Multi-centre, Dose-escalation, Cohort Study to Determine the Optimal Tolerated Regime and Safety of PEP005 Topical Gel When Applied to a 25 cm2 Contiguous Actinic Keratoses Treatment Area on the Face or Face and Scalp.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Peplin · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the optimal tolerated regime of PEP005 for the treatment of actinic keratoses of the face or face and scalp.

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 Keratoses

Interventions

Type	Name	Description
DRUG	PEP005

Timeline

• Start date: 2007-01-01
• Primary completion: 2007-11-01
• Completion: 2007-11-01
• First posted: 2007-01-26
• Last updated: 2015-09-14

Locations

9 sites across 2 countries: Australia, New Zealand