NCT00544258

Pharmacokinetic Study to Evaluate the Extent of Systemic Absorption of PEP005

A Phase I, Pharmacokinetic Study to Evaluate the Extent of Systemic Absorption of PEP005, When Applied as 0.05% PEP005 Topical Gel to a 100 cm2 (5 cm x 20 cm) Contiguous Actinic Keratosis(AK) Treatment Area on the Extensor (Dorsal Aspect) Forearm.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Peplin · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the extent of systemic absorption of PEP005 when applied topically 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 Keratoses

Interventions

Type	Name	Description
DRUG	PEP005

Timeline

• Start date: 2007-10-01
• Primary completion: 2008-05-01
• Completion: 2008-05-01
• First posted: 2007-10-16
• Last updated: 2015-02-12

Locations

1 site across 1 country: Australia