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

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

Official Title
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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

Conditions
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Actinic Keratosis

Intervention / Treatment
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* Drug: PEP005
* Drug: PEP005
* Drug: PEP005
* Drug: PEP005
* Drug: PEP005
* Drug: PEP005
* Drug: PEP005
* Drug: PEP005


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: PEP005<br>* 0.0025% PEP005 Topical Gel (Day 1,2 application)<br>|
| Experimental: 2<br> | Drug: PEP005<br>* 0.01% PEP005 Topical Gel (Day 1,2 application)<br>|
| Experimental: 3<br> | Drug: PEP005<br>* 0.05% PEP005 Topical Gel (Day 1,2 application)<br>|
| Placebo Comparator: 4<br> | Drug: PEP005<br>* Vehicle Gel (Day 1,2 application)<br>|
| Experimental: 5<br> | Drug: PEP005<br>* 0.0025% PEP005 Topical Gel (Day 1,8 application)<br>|
| Experimental: 6<br> | Drug: PEP005<br>* 0.01% PEP005 Topical Gel (Day 1,8 application)<br>|
| Experimental: 7<br> | Drug: PEP005<br>* 0.05% PEP005 Topical Gel (Day 1,8 application)<br>|
| Placebo Comparator: 8<br> | Drug: PEP005<br>* Vehicle Gel (Day 1,8 application)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the efficacy of PEP005 0.0025%, 0.01% and 0.05% Topical Gel in treating Actinic Keratoses |  | 85 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Actinic Keratosis, Solar Keratosis, AK, Sun spots, PEP005, Topical, Dermatology