Back to resultsPEP005 Gel - Evaluation of the Safety and Efficacy of Ingenol Mebutate Gel on a Superficial Basal Cell Carcinoma on the Trunk or Extremities
Primary Purpose
Superficial Basal Cell Carcinoma
Status
Completed
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
PEP005 (ingenol mebutate) Gel, 0.05%
Aluminium disk
OpSite(TM) disk
Sponsored by
About this trial
This is an interventional treatment trial for Superficial Basal Cell Carcinoma focused on measuring PEP005, Peplin, sBCC
Eligibility Criteria
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
Sites / Locations
- Southderm Pty Ltd
- St George Dermatology
- The Skin Centre
- Specialist Connect
- Dermatology Institute of Victoria
- St John of God Dermatology
- Burswood Dermatology
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Group 1
Group 2
Group 3
Arm Description
PEP005 0.05% gel applied and occluded with an aluminium disk for up to three consecutive days
PEP005 0.05% Gel applied and occluded with an OpSite(TM) disk up to three consecutive days
PEP005 0.05% applied with no occlusion for up to three consecutive days
Outcomes
Primary Outcome Measures
Treatment related Adverse Events, Local Skin Responses; Pigmentation and scarring
Number of participants with treatment related Adverse Events, change from baseline in LSR and pigmentation and scarring.
Secondary Outcome Measures
Histological and clinical clearance of sBCC lesions.
Number of participants with histological and clinical clearance of sBCC lesions.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01325688
Brief Title
PEP005 Gel - Evaluation of the Safety and Efficacy of Ingenol Mebutate Gel on a Superficial Basal Cell Carcinoma on the Trunk or Extremities
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peplin
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Superficial Basal Cell Carcinoma
Keywords
PEP005, Peplin, sBCC
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
PEP005 0.05% gel applied and occluded with an aluminium disk for up to three consecutive days
Arm Title
Group 2
Arm Type
Experimental
Arm Description
PEP005 0.05% Gel applied and occluded with an OpSite(TM) disk up to three consecutive days
Arm Title
Group 3
Arm Type
Experimental
Arm Description
PEP005 0.05% applied with no occlusion for up to three consecutive days
Intervention Type
Drug
Intervention Name(s)
PEP005 (ingenol mebutate) Gel, 0.05%
Intervention Description
PEP005 (ingenol mebutate) Gel, 0.05% for up to three consecutive days
Intervention Type
Device
Intervention Name(s)
Aluminium disk
Intervention Type
Device
Intervention Name(s)
OpSite(TM) disk
Primary Outcome Measure Information:
Title
Treatment related Adverse Events, Local Skin Responses; Pigmentation and scarring
Description
Number of participants with treatment related Adverse Events, change from baseline in LSR and pigmentation and scarring.
Time Frame
120 days
Secondary Outcome Measure Information:
Title
Histological and clinical clearance of sBCC lesions.
Description
Number of participants with histological and clinical clearance of sBCC lesions.
Time Frame
120 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacqueline Morley
Organizational Affiliation
Peplin Operations
Official's Role
Study Director
Facility Information:
Facility Name
Southderm Pty Ltd
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
St George Dermatology
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
The Skin Centre
City
Benowa
State/Province
Queensland
ZIP/Postal Code
4217
Country
Australia
Facility Name
Specialist Connect
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Dermatology Institute of Victoria
City
South Yarra
State/Province
Victoria
ZIP/Postal Code
3141
Country
Australia
Facility Name
St John of God Dermatology
City
Subiaco
State/Province
Western Australia
ZIP/Postal Code
6008
Country
Australia
Facility Name
Burswood Dermatology
City
Victoria Park
State/Province
Western Australia
ZIP/Postal Code
6100
Country
Australia
12. IPD Sharing Statement
Links:
URL
http://www.peplin.com
Description
Peplin
URL
http://www.tga.gov.au
Description
Therapeutic Goods Administration
Learn more about this trial
PEP005 Gel - Evaluation of the Safety and Efficacy of Ingenol Mebutate Gel on a Superficial Basal Cell Carcinoma on the Trunk or Extremities
We'll reach out to this number within 24 hrs