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

January 23, 2011 updated by: Peplin

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Kogarah, New South Wales, Australia, 2217
        • Southderm Pty Ltd
    • Queensland
      • Woolloongabba, Queensland, Australia, 4102
        • Specialist Connect

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Up to three days of treatment
Drug: PEP005 (ingenol mebutate) Gel
0.05%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
Time Frame: Day 43
Day 43

Secondary Outcome Measures

Outcome Measure
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.
Time Frame: Day 43
Day 43

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peplin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

October 3, 2010

First Submitted That Met QC Criteria

October 3, 2010

First Posted (Estimate)

October 5, 2010

Study Record Updates

Last Update Posted (Estimate)

January 25, 2011

Last Update Submitted That Met QC Criteria

January 23, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PEP005-033

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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