To Determine the Maximum Tolerated Dose Level (MTD) of PEP005 Topical Gel in Patients With sBCC

January 22, 2016 updated by: Peplin

An Open-label, Multi-center, Dose-escalation, Cohort Study to Determine the Maximum Tolerated Dose and Safety of PEP005 Topical Gel Given as Either a Single Application (on Day 1) or as Two Applications (on Day 1 and Day 8) to a Superficial Basal Cell Carcinoma (sBCC) on the Trunk.

The purpose of this study is to determine maximum tolerated dose level (MTD) of PEP005 Topical Gel for the treatment of superficial basal cell carcinoma on the trunk

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Basal cell carcinomas (BCCs) are a common skin problem largely caused by long term sun exposure. Current treatments include surgery, curettage/desiccation and simple excision, which are often cosmetically disfiguring. Non-invasive alternative therapy for treatment of BCC lesions is thus being researched. Sap from the plant Euphorbia peplus has been used for many years in Australia as a "folk" remedy to treat a number of skin conditions. The active component of Euphorbia peplus has been isolated and made into a gel applied directly to the skin by Peplin Opeation Pty Ltd.

The proposed study follows a previously conducted 12 week study in sBCC, PEP005-003. This was a two dose schedule evaluating doses up to 0.05%. Histological clearance rate at the end of study was 71% for the 0.05% concentration on the Day 1, Day 2 schedule compared with 0% in the vehicle group.

The proposed study aims to determine the maximum tolerated dose level (MTD) of PEP005 Topical Gel, in patients, when administered either as a single application or as two applications to a selected superficial basal cell carcinoma lesion with a 3 month follow up.

Study Type

Interventional

Enrollment (Actual)

117

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

  • United States
    • Arizona
      • Mesa, Arizona, United States, 85206
        • Alta Dermatology
    • California
      • Oceanside, California, United States, 92056
        • Dermatology Specialists Inc.
      • San Diego, California, United States, 92117
        • Skin Surgery Medical Group Inc.
    • Colorado
      • Denver, Colorado, United States, 80210
        • Colorado Medical Research Center
    • Florida
      • Clermont, Florida, United States, 34711
        • Advanced Dermatology and Cosmetic Surgery
      • Orange Park, Florida, United States, 32073
        • Park Avenue Dermatology
    • Minnesota
      • Fridley, Minnesota, United States, 55421
        • Minnesota Clinical Studies Center
    • New York
      • Rochester, New York, United States, 14623
        • Dermatology Associates of Rochester
    • Tennessee
      • Goodlettsville, Tennessee, United States, 37072
        • Rivergate Dermatology and Skin Care Center

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

  1. Male or female patients at least 18 years of age.
  2. A primary clinically diagnosed and histologically confirmed sBCC lesion located on the trunk which is suitable for excision the histological diagnosis should be made no more than 60 days prior to the screening visit the biopsy specimen should have removed no more that 20% of the total tumour mass
  3. Ability to follow study instructions and likely to complete all study requirements.
  4. Written informed consent has been obtained.
  5. Agreement from the patient to allow photographs of the selected lesion to be taken and used as part of the study data package.

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
One day treatment
Drug: PEP005
0.25% PEP005 Gel
Active Comparator: 2
Two day treatment
Drug: PEP005
0.25% PEP005 Gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum Tolerated Dose level (MTD) through incidence of treatment related AEs, local skin reactions and pigmentation and scarring.
Time Frame: 85 days
85 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Efficacy (complete sBCC clearance rate and composite sBCC clearance rate)
Time Frame: 85 days
85 days

Collaborators and Investigators

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

Sponsor

Peplin

Investigators

  • Study Director: Angela Smith, 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.

General Publications

  • Gross K. Safety and efficacy of ingenol mebutate (PEP005) gel for topical treatment of superficial basal cell carcinoma. J Am Acad Dermatol 2009; 60(3, Suppl. 1): AB141; P2928
  • Gross K, Schmieder GJ, Tu J. Maximum Tolerated Dose and Safety of PEP005 (ingenol mebutate) Gel for Topical Treatment of Superficial Basal Cell Carcinoma. Summer Academy, American Academy of Dermatology meeting, Boston, MA, 2009. 2009: Poster no. 1902 (31 p.)

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

February 1, 2007

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

February 6, 2007

First Submitted That Met QC Criteria

February 6, 2007

First Posted (Estimate)

February 7, 2007

Study Record Updates

Last Update Posted (Estimate)

February 15, 2016

Last Update Submitted That Met QC Criteria

January 22, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PEP005-009

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.

Clinical Trials on Superficial Basal Cell Carcinoma

Clinical Trials on PEP005

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ukraine

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe