A Multi-center Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel, When Used to Treat Actinic Keratoses on the Head (Face or Scalp)

Study Overview
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Brief Summary
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This Phase III study is designed to assess the efficacy and safety of PEP005 Gel, 0.015% when applied to an area of skin containing 4-8 AK lesions on the face or scalp.

Official Title
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A Multi-center, Randomized, Parallel Group, Double-blind, Vehicle-controlled Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel, 0.015% In Patients With Actinic Keratoses ON the Head (Face or Scalp) (REGION-IIa)

Conditions
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Actinic Keratosis

Intervention / Treatment
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* Drug: PEP005 Gel
* Drug: Vehicle gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is male or female and at least 18 years of age Female patients must be of either: Non-childbearing potential, post-menopausal Childbearing potential, provided there are negative serum and urine pregnancy test results prior to study treatment, to rule out pregnancy Exclusion Criteria: Cosmetic or therapeutic procedures within 2 weeks and 2cm of the selected treatment area 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 2 cm of the selected treatment area

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: PEP005 gel<br>PEP005 gel, 0.015% applied once daily for three consecutive days | Drug: PEP005 Gel<br>* 0.015%, three day treatment<br>* Other names: PEP005;|
| Placebo Comparator: Vehicle gel<br>Vehicle gel applied once daily for three consecutive days | Drug: Vehicle gel<br>* Vehicle gel, three day treatment<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients With Complete Clearance of Actinic Keratosis (AK) Lesions. | Complete clearance rate of actinic keratosis (AK) lesions, defined as the proportion of patients with no clinically visible AK lesions in the selected treatment area. | 57 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients With Partial Clearance of Actinic Keratosis (AK) | Patients with partial clearance defined as ≥ 75% reduction in the number of actinic keratosis (AK) lesions identified at baseline in the treatment area | baseline and 57 days | 

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