Study to Evaluate the Safety and Efficacy of PEP005(Ingenol Mebutate) Gel, 0.05%, in Patients With Seborrhoeic Keratosis

Study Overview
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Brief Summary
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This study is primarily designed to investigate whether treatment, once daily for up to three consecutive days, with PEP005 (ingenol mebutate) Gel, 0.05% will be safe and tolerable in patients with Seborrhoeic Keratosis on non-head locations. The secondary endpoint is to investigate the efficacy of PEP005 Gel, 0.05% when administered for up to three consecutive days to Seborrhoeic Keratosis on non-head locations.

Official Title
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A Phase 2a, Multi-Centre, Open-Label Study to Evaluate the Safety and Efficacy of PEP005(Ingenol Mebutate) Gel, 0.05%, in Patients With Seborrhoeic Keratosis on Non-head Locations

Conditions
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Seborrheic Keratosis

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 Patient is male or female and at least 18 years of age. 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 lesions 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: 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
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>* 0.05%<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, 0.05% when administered for up to three consecutive days to Seborrhoeic Keratosis on non-head locations. |  | Day 43 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the efficacy of PEP005 Gel, 0.05% when administered for up to three consecutive days to Seborrhoeic Keratosis on non-head locations. |  | Day 43 | 

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