A Study to Determine the Optimal Tolerated Regime and Safety of PEP005 Topical Gel

Peplin

Status and phase: Completed; Phase 2

Conditions: Actinic Keratoses

Treatments: Drug: PEP005

Study type: Interventional

Funder types: Industry

Identifiers

NCT00427050

PEP005-007

Details and patient eligibility

About

The purpose of this study is to determine the optimal tolerated regime of PEP005 for the treatment of actinic keratoses of the face or face and scalp.

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: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

1. Male patients at least 18 years of age.

2. Post-menopausal female patients i.e., no menses for at least 12 consecutive months, or without a uterus.

3. Four to eight clinically typical, visible and discrete AK lesions within a contiguous 25 cm2 treatment area on the face or face and scalp.

4. Ability to follow study instructions and likely to complete all study requirements.

5. Written informed consent has been obtained. 7. 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)