PEP005 Gel - Evaluation of the Safety and Efficacy of Ingenol Mebutate Gel on a Superficial Basal Cell Carcinoma on the Trunk or Extremities

January 27, 2016 updated by: Peplin

A Phase 2 Multi-centre, Parallel Group, Open Label Study to Evaluate the Safety and Efficacy of PEP005 (Ingenol Mebutate) Gel, 0.05%, When Administered for up to Three Consecutive Days to a Superficial Basal Cell Carcinoma (sBCC) on the Trunk or Extremities

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 superficial Basal Cell Carcinoma (sBCC) lesions on the trunk and extremities.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

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
      • Kogarah, New South Wales, Australia, 2217
        • St George Dermatology
    • Queensland
      • Benowa, Queensland, Australia, 4217
        • The Skin Centre
      • Woolloongabba, Queensland, Australia, 4102
        • Specialist Connect
    • Victoria
      • South Yarra, Victoria, Australia, 3141
        • Dermatology Institute of Victoria
    • Western Australia
      • Subiaco, Western Australia, Australia, 6008
        • St John of God Dermatology
      • Victoria Park, Western Australia, Australia, 6100
        • Burswood Dermatology

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:

  • Must be male or female and at least 18 years of age
  • Female patients must be of: non-childbearing potential or if of childbearing potential then have a negative serum and urine pregnancy test and using effective contraception
  • Ability to provide informed consent
  • primary diagnosed and histologically confirmed sBCC located on the trunk or extremities which is suitable for excision

Exclusion Criteria:

  • location of the sBCC lesion within 10cm of an incompletely healed wound, on the hand or foot, on the breast of women, on the anogenital area.
  • Undergone cosmetic or therapeutic procedures within 2cm of the selected treatment area in the 2 weeks prior to the screening visit.
  • Use of acid-containing therapeutic products within 2 cm of the selected treatment area in the 2 weeks prior to the screening visit
  • Use of topical moisturisers/creams/lotions (non-medicated/non-irritant salves are acceptable), artificial tanners or topical steroids: within 2 cm of the selected treatment area.
  • Have received treatment with immunomodulators, or interferon/interferon inducers, systematic medications that suppress the immune system or UVB in the last 4 weeks
  • Have undergone treatment with 5-FU, imiquimod, diclofenac or photodynamic therapy within 2 cm of the selected treatment area within 8 weeks prior to any screening visit.
  • Use of systemic retinoids.
  • Those who are currently participating in any other clinical trial
  • Those known or suspected of not being able to comply with the requirements of the protocol
  • Females who are pregnant or are breastfeeding

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
PEP005 0.05% gel applied and occluded with an aluminium disk for up to three consecutive days
Drug: PEP005 (ingenol mebutate) Gel, 0.05%
PEP005 (ingenol mebutate) Gel, 0.05% for up to three consecutive days
Device: Aluminium disk
Experimental: Group 2
PEP005 0.05% Gel applied and occluded with an OpSite(TM) disk up to three consecutive days
Drug: PEP005 (ingenol mebutate) Gel, 0.05%
PEP005 (ingenol mebutate) Gel, 0.05% for up to three consecutive days
Device: OpSite(TM) disk
Experimental: Group 3
PEP005 0.05% applied with no occlusion for up to three consecutive days
Drug: PEP005 (ingenol mebutate) Gel, 0.05%
PEP005 (ingenol mebutate) Gel, 0.05% for up to three consecutive days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment related Adverse Events, Local Skin Responses; Pigmentation and scarring
Time Frame: 120 days
Number of participants with treatment related Adverse Events, change from baseline in LSR and pigmentation and scarring.
120 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Histological and clinical clearance of sBCC lesions.
Time Frame: 120 days
Number of participants with histological and clinical clearance of sBCC lesions.
120 days

Collaborators and Investigators

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

Sponsor

Peplin

Investigators

  • Study Director: Jacqueline Morley, Peplin Operations

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

April 1, 2011

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

March 25, 2011

First Submitted That Met QC Criteria

March 28, 2011

First Posted (Estimate)

March 30, 2011

Study Record Updates

Last Update Posted (Estimate)

February 26, 2016

Last Update Submitted That Met QC Criteria

January 27, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PEP005-037

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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