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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01214577

Enrollment

Registered

2010-10-05

Start date

2010-10-31

Completion date

2011-01-31

Last updated

2011-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Photo-damage

Keywords

PEP005, Peplin, Photo-damage

Brief summary

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.

Interventions

DRUGPEP005 (ingenol mebutate) Gel

0.015%

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

30 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	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

Measure	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

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026