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Study to Determine the Safety of Two Applications of PEP005 Topical Gel to Superficial Basal Cell Carcinoma

Primary Purpose

Basal Cell Carcinoma

Status
Completed
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
PEP005
Sponsored by
Peplin
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Basal Cell Carcinoma focused on measuring Superficial basal cell carcinoma, basal cell carcinoma, sBCC, BCC, PEP005, Topical, Dermatology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or female patients at least 18 years of age One sBCC on the arm, shoulder, chest, face, neck, abdomen, leg, back or scalp suitable for surgical excision Histological confirmation of sBCC based on the central dermatopathologist's evaluation of the punch biopsy Longest pre- and post-biopsy diameter of the sBCC lesion between 4 mm and 15 mm Maximum thickness of 4 mm of the sBCC 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 sBCC selected for treatment: within 10 cm of a malignant lesion that will require treatment during the study within 5 cm of an incompletely healed wound within 2 cm of a pre-malignant lesion (e.g. actinic keratosis lesion) within 2 cm of the open eyelid margins within 1 cm of a scar or an area previously treated with surgical excision on the lips on the breast on the hand or foot in a skin crease sBCC lesion selected for treatment requiring Mohs micrographic surgery Presence of known or suspected metastatic disease Histological evidence of actinic keratoses or nBCC 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 sBCC 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 sBCC 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: of lesions located within 10 cm of the selected sBCC lesion during the 3 months prior to study entry or 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 sBCC 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)

Sites / Locations

  • Southderm Pty Ltd
  • St George Dermatology & Skin Cancer Centre
  • Siller Medical
  • Belmont Specialist Centre
  • The Skin Centre
  • Skin and Cancer Foundation
  • Freemantle Dermatology
  • Private Dermaology Clinic
  • St John of God Dermatology

Outcomes

Primary Outcome Measures

Safety

Secondary Outcome Measures

Efficacy

Full Information

First Posted
April 14, 2005
Last Updated
December 22, 2008
Sponsor
Peplin
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1. Study Identification

Unique Protocol Identification Number
NCT00108134
Brief Title
Study to Determine the Safety of Two Applications of PEP005 Topical Gel to Superficial Basal Cell Carcinoma
Official Title
A Multi-Center, Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled Study to Determine the Safety of PEP005 0.0025%, 0.01% and 0.05% Gel With Two Treatment Schedules, Day 1 & 2 or Day 1 & 8 Applications to Superficial Basal Cell Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
March 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Peplin

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to determine whether topical application of PEP005 is safe for the treatment of superficial basal cell carcinoma.
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 superficial basal cell carcinoma (sBCC) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Basal Cell Carcinoma
Keywords
Superficial basal cell carcinoma, basal cell carcinoma, sBCC, BCC, PEP005, Topical, Dermatology

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
PEP005
Primary Outcome Measure Information:
Title
Safety
Secondary Outcome Measure Information:
Title
Efficacy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female patients at least 18 years of age One sBCC on the arm, shoulder, chest, face, neck, abdomen, leg, back or scalp suitable for surgical excision Histological confirmation of sBCC based on the central dermatopathologist's evaluation of the punch biopsy Longest pre- and post-biopsy diameter of the sBCC lesion between 4 mm and 15 mm Maximum thickness of 4 mm of the sBCC 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 sBCC selected for treatment: within 10 cm of a malignant lesion that will require treatment during the study within 5 cm of an incompletely healed wound within 2 cm of a pre-malignant lesion (e.g. actinic keratosis lesion) within 2 cm of the open eyelid margins within 1 cm of a scar or an area previously treated with surgical excision on the lips on the breast on the hand or foot in a skin crease sBCC lesion selected for treatment requiring Mohs micrographic surgery Presence of known or suspected metastatic disease Histological evidence of actinic keratoses or nBCC 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 sBCC 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 sBCC 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: of lesions located within 10 cm of the selected sBCC lesion during the 3 months prior to study entry or 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 sBCC 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Greg Siller
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southderm Pty Ltd
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
St George Dermatology & Skin Cancer Centre
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Siller Medical
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4000
Country
Australia
Facility Name
Belmont Specialist Centre
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4152
Country
Australia
Facility Name
The Skin Centre
City
Gold Coast
State/Province
Queensland
ZIP/Postal Code
4217
Country
Australia
Facility Name
Skin and Cancer Foundation
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3053
Country
Australia
Facility Name
Freemantle Dermatology
City
Freemantle
State/Province
Western Australia
ZIP/Postal Code
6160
Country
Australia
Facility Name
Private Dermaology Clinic
City
Fremantle
State/Province
Western Australia
ZIP/Postal Code
6160
Country
Australia
Facility Name
St John of God Dermatology
City
Subiaco
State/Province
Western Australia
ZIP/Postal Code
6008
Country
Australia

12. IPD Sharing Statement

Links:
URL
http://www.peplin.com
Description
Sponsor's Home Page

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Study to Determine the Safety of Two Applications of PEP005 Topical Gel to Superficial Basal Cell Carcinoma

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