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

Peplin

Status and phase: Completed; Phase 2

Conditions: Seborrheic Keratosis

Treatments: Drug: PEP005 (ingenol mebutate) Gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT01214564

PEP005-033

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

1. Patient is male or female and at least 18 years of age.

2. 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.

3. 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.

4. 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

1. Known sensitivity or allergy to any of the ingredients in PEP005 (ingenol mebutate)Gel.
2. Current enrolment or participation in a clinical research study within 30 days of entry into this study.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

1

Experimental group

Description:

Up to three days of treatment

Treatment:

Drug: PEP005 (ingenol mebutate) Gel