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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00544297

Enrollment

Registered

2007-10-16

Start date

2007-10-31

Completion date

2008-01-31

Last updated

2015-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Actinic Keratosis

Keywords

Actinic Keratosis, Topical, Dermatology, Hand

Brief summary

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.

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.

Interventions

DRUGPEP005 gel

Two day application, 0.05%

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs); and Local Skin Responses (LSR)	57 days

Secondary

Measure	Time frame
The complete clearance rate of AK lesions; partial clearance rate of AK lesions and baseline clearance rate of AK lesions.	57 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026