Pharmacokinetic Study to Evaluate the Extent of Systemic Absorption of PEP005

This study has been completed.

Sponsor:

Information provided by:

Peplin

ClinicalTrials.gov Identifier:

NCT00544258

First received: October 14, 2007

Last updated: May 22, 2008

Last verified: May 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

October 14, 2007

Last Updated Date

May 22, 2008

Start Date ^ICMJE

October 2007

Primary Completion Date

May 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00544258 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Pharmacokinetic Study to Evaluate the Extent of Systemic Absorption of PEP005

Official Title ^ICMJE

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.

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 Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Actinic Keratoses

Intervention ^ICMJE

Drug: PEP005

Study Arm (s)

Experimental: 1

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

Intervention: Drug: PEP005

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

May 2008

Primary Completion Date

May 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Gender

Male

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Australia

Administrative Information

NCT Number ^ICMJE

NCT00544258

Other Study ID Numbers ^ICMJE

PEP005-013

Has Data Monitoring Committee

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Peplin

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Janelle Katsamas

Peplin

Information Provided By

Peplin

Verification Date

May 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top