PEP005 in Basal Cell Carcinoma - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Basal Cell Carcinoma

Intervention / Treatment

Drug: PEP005

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 Ltd. To date, only one well-controlled study with PEP005 gel in humans has been completed. Sixteen patients received a single application of PEP005 0.01% or vehicle gel to actinic keratoses on the chest, shoulders, back and/or arms. Results show good tolerance and evidence of activity.

The current study is designed to evaluate the safety of two applications of PEP005 gel in patients with nBCC (nodular basal cell carcinoma) on the arms, shoulders, chest, face and/or scalp, testing three concentrations according to two treatment regimens. Approximately 60 patients are planned to be included from multiple Australian centers.

Efficacy and cosmetic outcome will be assessed and a recommended treatment regimen will be determined. Assignment to treatment is random and patients and medical staff will be blinded as to the treatment.

Patients will have two visits for treatment application and will return for check-up visits the day after the first application and several times thereafter for approximately 3 months.

Study Type

Interventional

Enrollment

60

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
  - Sydney, New South Wales, Australia, 2010
    - Southderm Pty Ltd
  - Sydney, New South Wales, Australia, 2217
    - St George Dermatology & Skin Cancer Centre
- Queensland
  - Brisbane, Queensland, Australia, 4000
    - Siller Medical
  - Brisbane, Queensland, Australia, 4152
    - South East Dermatology
  - Gold Coast, Queensland, Australia, 4217
    - The Skin Centre
- Victoria
  - Footscray, Victoria, Australia, 3011
    - 13 Eleanor St
  - Melbourne, Victoria, Australia, 3168
    - Monash Medical Centre
  - Melbourne, Victoria, Australia, 3052
    - Skin and Cancer Foundation
- Western Australia
  - Fremantle, Western Australia, Australia, 6160
    - Fremantle Dermatology
  - Subiaco, Western Australia, Australia, 6008
    - St John of God 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:

Male or female patients at least 18 years of age
One nBCC on the arm, shoulder, chest, face, neck, abdomen, leg, back or scalp suitable for surgical excision
Histological confirmation of nBCC based on the central dermatopathologist's evaluation of the punch biopsy
Longest pre- and post-biopsy diameter of the nBCC lesion between 4 mm and 15 mm
Maximum thickness of 4 mm of the nBCC lesion
Laboratory values within the reference ranges as defined by the central laboratory or "out of range" test results that are clinically acceptable to the Investigator
Ability to follow study instructions and likely to complete all study requirements
Written informed consent
Male patients with a female partner of childbearing potential must use an approved form of contraception during the study and for 4 weeks after the last visit
Agreement from the patient to allow photographs of all selected lesions (including the face) to be taken and used as part of the study data package

Exclusion Criteria:

Location of the outside margin of the anticipated treatment area of the nBCC selected for treatment:
1. within 10 cm of a malignant lesion that will require treatment during the study
2. within 5 cm of an incompletely healed wound
3. within 2 cm of a pre-malignant lesion (e.g. actinic keratosis lesion)
4. within 2 cm of the open eyelid margins
5. within 1 cm of a scar or an area previously treated with surgical excision
6. on the lips
7. on the breast
8. on the hand or foot
9. in a skin crease
nBCC lesion selected for treatment requiring Mohs micrographic surgery
Presence of known or suspected metastatic disease
Histological evidence of actinic keratoses or sBCC (superficial basal cell carcinoma) in the screening visit biopsy sample
Histological evidence of BCC with micro-nodular features or squamous metaplasia, sclerosing BCC (i.e. desmoplastic or morphoeic), or BCC with perineural involvement in the screening visit biopsy sample
History of recurrence of the nBCC lesion
History or evidence of skin diseases which would interfere with evaluation of the treatment area (e.g. eczema, unstable psoriasis, xeroderma pigmentosa)
Known sensitivity to any of the ingredients in the study medication
A cosmetic or therapeutic procedure (e.g. use of liquid nitrogen, surgical excision, curettage, dermabrasion, medium or greater depth chemical peel, laser resurfacing) within 10 cm of the selected nBCC lesion during the 3 months prior to study entry or anticipated treatment within 10 cm of the selected lesion during the study
Treatment with 5-fluorouracil, imiquimod, diclofenac or photodynamic therapy:
1. of lesions located within 10 cm of the selected nBCC lesion during the 3 months prior to study entry or
2. anywhere during the 4 weeks prior to study entry or anticipated treatment during the study
Use of acid-containing products (e.g. salicylic acids or fruit acids, such as alpha and beta hydroxy acids and glycolic acids), topical retinoids or light chemical peels within 10 cm of the selected nBCC lesion during the 3 months prior to study entry or anticipated treatment in this same area during the study
Treatment with immuno-modulators (e.g. cyclosporine, prednisone, methotrexate, infliximab or other biological agents), cytotoxic drugs (e.g. vinblastine, cyclophosphamide, azathioprine, chlorambucil, methotrexate), or interferon/interferon inducers during the 4 weeks prior to study entry or anticipated treatment during the study
Treatment with psoralen plus UVA or use of UVB therapy during the 6 months prior to study entry or anticipated treatment during the study
Use of systemic retinoids (e.g. isotretinoin, acitretin) during the 6 months prior to study entry or anticipated treatment during the study
Anticipated excessive or prolonged exposure to ultraviolet light (e.g. sunlight, tanning beds) or use of topical salves, creams or ointments to the selected lesion during the study
Anticipated need for hospitalization or non-dermatological surgery during the study
Concurrent disease that suppresses the immune system (e.g. HIV) or uncontrolled systemic disease (e.g. uncontrolled hypertension, poorly controlled diabetes)
Current evidence of chronic alcohol or drug abuse
Current enrolment in an investigational drug or device study or participation in such a study within 30 days of entry into this study
Diagnosis of xeroderma pigmentosa or Gorlin Syndrome (i.e. Basal Cell Nevus Syndrome)
A condition or situation which in the Investigator's opinion may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study
Females of child bearing potential (a female is considered of childbearing potential unless she is postmenopausal, i.e., no menses for at least 12 consecutive months, or is without a uterus)

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
Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Safety

Secondary Outcome Measures

Outcome Measure
Resolution of nodular basal cell carcinoma

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.

General Publications

Rosen RH, Katsamas J, Ogbourne SM, Welburn P. Early phase clinical development of PEP005 topical gel for basal cell carcinoma. 21st World Congress of Dermatology, Buenos Aires, 2007. 2007: Poster no. P5755 (1 p.)
Rosen RH, Freeman M, Siller G, Katsamas J, Ogbourne SM. Safety and efficacy of PEP005 Topical Gel for the treatment of nodular and superficial forms of basal cell carcinoma. Summer Academy, American Academy of Dermatology meeting, New York, NY, 2007. 2007: Poster no. P1502

Helpful Links

Sponsor's Home Page

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

March 1, 2005

Primary Completion (Actual)

May 1, 2006

Study Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

April 14, 2005

First Submitted That Met QC Criteria