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

Peplin

Status and phase: Completed; Phase 2

Conditions: Photo-damage

Treatments: Drug: PEP005 (ingenol mebutate) Gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT01214577

PEP005-036

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

1. Male and female patients aged 30 to 65 years.

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 area 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