NCT00107965

Study to Determine the Safety of Two Applications of PEP005 Topical Gel to Actinic Keratoses

A Multi-center, Randomized, Double-blind, Parallel-group, Vehicle-controlled Study to Determine the Safety of PEP005 0.0025%, 0.01% and 0.05% Gel With Two Treatment Schedules, Day 1 & 2 or Day 1 & 8 Applications to Actinic Keratoses

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (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.

Conditions

• Actinic Keratosis

Interventions

Type	Name	Description
DRUG	PEP005	0.0025% PEP005 Topical Gel (Day 1,2 application)
DRUG	PEP005	0.01% PEP005 Topical Gel (Day 1,2 application)
DRUG	PEP005	0.05% PEP005 Topical Gel (Day 1,2 application)
DRUG	PEP005	Vehicle Gel (Day 1,2 application)
DRUG	PEP005	0.0025% PEP005 Topical Gel (Day 1,8 application)
DRUG	PEP005	0.01% PEP005 Topical Gel (Day 1,8 application)
DRUG	PEP005	0.05% PEP005 Topical Gel (Day 1,8 application)
DRUG	PEP005	Vehicle Gel (Day 1,8 application)

Timeline

• Start date: 2005-03-01
• Primary completion: 2005-09-01
• Completion: 2005-09-01
• First posted: 2005-04-12
• Last updated: 2015-03-25

Locations

6 sites across 1 country: Australia