Study to Determine the Safety of Two Applications of PEP005 Topical Gel to Actinic Keratoses

A Multi-center, Randomized, Double-blind, Parallel-group, Vehicle-controlled Study to Determine the Safety of PEP005 0.0025%, 0.01% and 0.05% Gel With Two Treatment Schedules, Day 1 & 2 or Day 1 & 8 Applications to Actinic Keratoses

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00107965

Enrollment

Registered

2005-04-12

Start date

2005-03-31

Completion date

2005-09-30

Last updated

2015-03-25

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, Solar Keratosis, AK, Sun spots, PEP005, Topical, Dermatology

Brief summary

The purpose of this study is to determine whether topical application of PEP005 is safe for the treatment of actinic keratoses.

Interventions

DRUGPEP005

0.0025% PEP005 Topical Gel (Day 1,2 application)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Male or female patients * At least five individual AK lesions on the arms, shoulders, chest, face and/or scalp

Exclusion criteria

* A cosmetic or therapeutic procedure: * within 10 cm of the selected AK lesions during the 3 months prior to study entry or * anywhere during the 4 weeks prior to study entry or anticipated treatment during the study * Treatment with 5-fluorouracil, imiquimod, diclofenac or photodynamic therapy: * of lesions located within 10 cm of the selected AK lesions during the 3 months prior to study entry or * anywhere during the 4 weeks prior to study entry or anticipated treatment during the study * Use of acid-containing products, topical retinoids or light chemical peels within 10 cm of the selected AK lesions during the 3 months prior to study entry, or anticipated treatment in this same area during the study * Treatment with immuno-modulators, cytotoxic drugs, or interferon/interferon inducers during the 4 weeks prior to study entry or anticipated treatment during the study * Treatment with psoralen plus UVA or use of UVB therapy during the 6 months prior to study entry or anticipated treatment during the study * Use of systemic retinoids during the 6 months prior to study entry or anticipated treatment during the study * Anticipated excessive or prolonged exposure to ultraviolet light or use of topical salves, creams or ointments to the selected AK lesions during the study * Females of childbearing potential

Design outcomes

Primary

Measure	Time frame
To determine the safety of PEP005 Topical Gel at 0.0025%, 0.01%, and 0.05% administered as two applications to patients with actinic keratosis (AKs) on the arms, shoulders, chest, face, and/or scalp	85 days

Secondary

Measure	Time frame
To evaluate the efficacy of PEP005 0.0025%, 0.01% and 0.05% Topical Gel in treating Actinic Keratoses	85 days

Countries

Australia

Outcome results

None listed

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