Study to Evaluate the Safety and Efficacy of PEP005 (Ingenol Mebutate) Gel, 0.015%, in Patients With Photo-damaged Skin

Study Overview
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Brief Summary
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This study is primarily designed to evaluate the safety and tolerability of PEP005 Gel, 0.015% when administered for up to three consecutive days to photo-damaged skin on the face. The secondary endpoint is to determine the efficacy of PEP005 Gel, 0.015% when administered for up to three consecutive days in patients with photo-damaged skin on the face.

Official Title
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A Phase 2a, Multi-Centre, Single Arm Study to Evaluate the Safety and Efficacy of PEP005(Ingenol Mebutate) Gel, 0.015%, in Patients With Photo-damaged Skin on the Face

Conditions
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Photo-damage

Intervention / Treatment
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* Drug: PEP005 (ingenol mebutate) Gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Male and female patients aged 30 to 65 years. Female patients must be of either: Non-childbearing potential, provided there is a laboratory confirmed serum follicle stimulating hormone (FSH) level ≥ 40mIU/ml or there is a confirmed clinical history of sterility (e.g., the patient is without a uterus); or Childbearing potential, provided there are negative urine pregnancy test results prior to study treatment, to rule out pregnancy. Patient has provided informed consent documented by signing the Informed Consent Form (ICF) prior to any study-related procedures, including any alteration of medications in preparation for study entry. Patient has agreed to allow photographs of the selected treatment area to be taken and used as part of the study data package. Exclusion Criteria Known sensitivity or allergy to any of the ingredients in PEP005 (ingenol mebutate) Gel. Current enrolment or participation in a clinical research study within 30 days of entry into this study.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Up to three days of treatment | Drug: PEP005 (ingenol mebutate) Gel<br>* 0.015%<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety of PEP005 Gel, 0.015% when administered for up to three consecutive days to photo-damaged skin on the face. |  | Day 43 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the efficacy of PEP005 Gel, 0.015% when administered for up to three consecutive days in patients with photo-damaged skin on the face. |  | Day 43 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PEP005, Peplin, Photo-damage