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

Peplin

Status and phase

Completed

Phase 2

Conditions

Actinic Keratosis

Treatments

Drug: PEP005 gel

Study type

Interventional

Funder types

Industry

Identifiers

NCT00544297

PEP005-018

Details and patient eligibility

About

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.

Full 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.

Enrollment

12 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.