Pharmacokinetic Study to Evaluate the Extent of Systemic Absorption of PEP005

Peplin

Status and phase: Completed; Phase 1

Conditions: Actinic Keratoses

Treatments: Drug: PEP005

Study type: Interventional

Funder types: Industry

Identifiers

NCT00544258

PEP005-013

Details and patient eligibility

About

The purpose of this study is to determine the extent of systemic absorption of PEP005 when applied topically for the treatment of actinic keratoses.

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: 8 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

1

Experimental group

Description:

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

Treatment:

Drug: PEP005