Pharmacokinetic Study to Evaluate the Extent of Systemic Absorption of PEP005

Phase 1

Completed

• Conditions: Actinic Keratoses
• Interventions: Drug: PEP005

• Registration Number: NCT00544258
• Lead Sponsor: Peplin

Brief 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.

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-10-14
• Study First Submitted QC: 2007-10-15
• Study First Posted: 2007-10-16
• Status Verified: 2008-05
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Last Update Submitted: 2015-02-11
• Last Update Posted: 2015-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 8

Inclusion Criteria

1. Male patients at least 18 years of age.
2. A contiguous 100 cm2 treatment area containing at least 5 AK lesions, on the either the right or left extensor (dorsal aspect) forearm.
3. Written informed consent has been obtained.
4. Agreement from the patient to allow photographs of the selected AK treatment area to be taken and used as part of the study package.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	PEP005	Two days consecutive days of application of 0.05% PEP005 Topical Gel to a 100cm2 contiguous AK treatment area of the arm.

Primary Outcome Measures

Name	Time	Method
To evaluate the extent of systemic absorption of PEP005 when applied as 0.05% Topical Gel on two consecutive days (Day 1 and Day 2) to a 100 cm2 (5 cm x 20 cm) contiguous AK treatment area on the extensor (dorsal aspect) forearm.

Secondary Outcome Measures

Name	Time	Method
To evaluate the safety and tolerability of two consecutive days of application of 0.05% PEP005 Topical Gel, when applied to a 100 cm2 (5 cm x 20 cm) contiguous AK treatment area on the extensor (dorsal aspect) forearm.

Trial Locations

Locations (1)

Siller Medical; 🇦🇺 Silverton Place, 101 Wickham Terrace, Brisbane, Queensland, Australia