Skip to main content
OpenTrials
Completed

NCT Number: NCT00544297

A Study to Examine the Safety and Toleration of PEP005 Topical Gel in Patients With Actinic Keratoses on the Top of the Hand

The purpose of this study is to examine the safety and toleration of PEP005 Topical Gel, administered on an actinic keratosis (AK) treatment area on the top of a hand.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Actinic Keratosis Keratosis Keratosis, Actinic Neoplasms Precancerous Conditions Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Skin Surgery Medical Group Inc, San Diego, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male patients at least 18 years of age.
  • Post-menopausal female patients
  • 4 to 8 clinically typical, visible and discrete AK lesions within an area on the dorsum of one hand.
  • 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 data package.

Treatment and study plan

PEP005 Gel

Drug

Two day application, 0.05%

Other names: PEP005

Primary outcomes

  1. Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs); and Local Skin Responses (LSR)

    Time frame: 57 days

Secondary outcomes

  1. The complete clearance rate of AK lesions; partial clearance rate of AK lesions and baseline clearance rate of AK lesions.

    Time frame: 57 days

Sponsors and collaborators

Lead sponsor

Peplin

Industry

Collaborators

  • Omnicare Clinical Research

Registry information

Official study title

A Multi-center, Open-label Study to Examine the Safety and Toleration of 0.05% PEP005 Topical Gel in Patients With Actinic Keratoses on the Dorsum of the Hand

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Oct 16, 2007
Registry last updated
Apr 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.