Safety and Toleration of PEP005 Topical Gel When Applied to a Treatment Area of up to 100cm2

Study Overview
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Brief Summary
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Study Hypothesis: Safety and Tolerability will differ when treating multiple contiguous 25 cm2 treatment areas, as compared to individual 25 cm2 treatment areas.

Official Title
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A Multi-center, Open Label, Dose-area Escalation, Cohort Study to Evaluate the Safety and Tolerability of 0.05% PEP005 Topical Gel Applied for Two Consecutive Days to Treatment Area(s) of up to a Total of 100 cm2 in Patients With Actinic Keratoses on the Extensor (Dorsal Aspect) Forearm(s)

Conditions
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Actinic Keratosis

Intervention / Treatment
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* Drug: PEP005 Topical gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be male and at least 18 years of age. A 100 cm2 contiguous treatment area on each of the right and left extensor (dorsal aspect) forearms, each containing a minimum of 5 AK lesions. Exclusion Criteria: Cosmetic or therapeutic procedures (e.g., use of liquid nitrogen, surgical excision, curettage, dermabrasion, medium or greater depth chemical peel, laser resurfacing): within 2 weeks and within 2 cm of the selected treatment area(s). Treatment with immunomodulators, or interferon/ interferon inducers or systemic medications that suppress the immune system: within 4 weeks. Treatment with 5-FU, imiquimod, diclofenac, or photodynamic therapy: within 8 weeks and within 2 cm of the selected treatment area(s).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

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: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Cohort 1 One 25 cm2 treatment area; on one arm | Drug: PEP005 Topical gel<br>* 0.05%, two day dose<br>|
| Experimental: 2<br>Cohort 2 One 50cm2 contiguous treatment area; on one arm | Drug: PEP005 Topical gel<br>* 0.05%, two day dose<br>|
| Experimental: 3<br>Cohort 3 Two 25cm2 treatment areas; one on each arm | Drug: PEP005 Topical gel<br>* 0.05%, two day dose<br>|
| Experimental: 4<br>Cohort 4 One 25cm2 treatment area; and one 50cm2 contiguous treatment area; one on each arm | Drug: PEP005 Topical gel<br>* 0.05%, two day dose<br>|
| Experimental: 5<br>Cohort 5 One 75cm2 contiguous treatment area; on one arm | Drug: PEP005 Topical gel<br>* 0.05%, two day dose<br>|
| Experimental: 6<br>Cohort 6 Two 50cm2 contiguous treatment area; one on each arm | Drug: PEP005 Topical gel<br>* 0.05%, two day dose<br>|
| Experimental: 7<br>Cohort 7 One 25cm2 treatment area; and one 75cm2 contiguous treatment area; one on each arm | Drug: PEP005 Topical gel<br>* 0.05%, two day dose<br>|
| Experimental: 8<br>Cohort 8 One 100cm2 contiguous treatment area; on one arm | Drug: PEP005 Topical gel<br>* 0.05%, two day dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability (incidence of AEs, SAEs and skin responses) |  | Screening to End of Study (Day 57) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peplin, PEP005, Actinic Keratosis