Study to Determine the Safety of Two Applications of PEP005 Topical Gel to Actinic Keratoses
- Registration Number
- NCT00107965
- Lead Sponsor
- Peplin
- Brief Summary
The purpose of this study is to determine whether topical application of PEP005 is safe for the treatment of actinic keratoses.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- Male or female patients
- At least five individual AK lesions on the arms, shoulders, chest, face and/or scalp
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 PEP005 - 8 PEP005 - 1 PEP005 - 6 PEP005 - 4 PEP005 - 7 PEP005 - 3 PEP005 - 5 PEP005 -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method To evaluate the efficacy of PEP005 0.0025%, 0.01% and 0.05% Topical Gel in treating Actinic Keratoses 85 days
Trial Locations
- Locations (6)
Royal Prince Alfred Hospital
🇦🇺Sydney, New South Wales, Australia
Siller Medical
🇦🇺Brisbane, Queensland, Australia
Private Dermaology Clinic
🇦🇺Fremantle, Western Australia, Australia
Fremantle Dermatology
🇦🇺Fremantle, Western Australia, Australia
Monash Medical Centre
🇦🇺Melbourne, Victoria, Australia
Skin and Cancer Foundation
🇦🇺Melbourne, Victoria, Australia