Back to resultsStudy to Evaluate the Safety and Efficacy of PEP005(Ingenol Mebutate) Gel, 0.05%, in Patients With Seborrhoeic Keratosis
Primary Purpose
Seborrheic Keratosis
Status
Completed
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
PEP005 (ingenol mebutate) Gel
Sponsored by
About this trial
This is an interventional treatment trial for Seborrheic Keratosis focused on measuring PEP005, Peplin, Seborrhoeic Keratosis
Eligibility Criteria
Inclusion Criteria
- Patient is male or female and at least 18 years of age.
Female patients must be of either:
- Non-childbearing potential, provided there is a laboratory confirmed serum follicle stimulating hormone (FSH) level ≥ 40mIU/ml or there is a confirmed clinical history of sterility (e.g., the patient is without a uterus); or
- Childbearing potential, provided there are negative urine pregnancy test results prior to study treatment, to rule out pregnancy.
- Patient has provided informed consent documented by signing the Informed Consent Form (ICF) prior to any study-related procedures, including any alteration of medications in preparation for study entry.
- Patient has agreed to allow photographs of the selected treatment lesions to be taken and used as part of the study data package.
Exclusion Criteria
- Known sensitivity or allergy to any of the ingredients in PEP005 (ingenol mebutate)Gel.
- Current enrolment or participation in a clinical research study within 30 days of entry into this study.
Sites / Locations
- Southderm Pty Ltd
- Specialist Connect
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Up to three days of treatment
Outcomes
Primary Outcome Measures
To evaluate the safety of PEP005 Gel, 0.05% when administered for up to three consecutive days to Seborrhoeic Keratosis on non-head locations.
Secondary Outcome Measures
To determine the efficacy of PEP005 Gel, 0.05% when administered for up to three consecutive days to Seborrhoeic Keratosis on non-head locations.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01214564
Brief Title
Study to Evaluate the Safety and Efficacy of PEP005(Ingenol Mebutate) Gel, 0.05%, in Patients With Seborrhoeic Keratosis
Official Title
A Phase 2a, Multi-Centre, Open-Label Study to Evaluate the Safety and Efficacy of PEP005(Ingenol Mebutate) Gel, 0.05%, in Patients With Seborrhoeic Keratosis on Non-head Locations
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
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 Seborrhoeic Keratosis on non-head locations. The secondary endpoint is to investigate the efficacy of PEP005 Gel, 0.05% when administered for up to three consecutive days to Seborrhoeic Keratosis on non-head locations.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seborrheic Keratosis
Keywords
PEP005, Peplin, Seborrhoeic Keratosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Up to three days of treatment
Intervention Type
Drug
Intervention Name(s)
PEP005 (ingenol mebutate) Gel
Intervention Description
0.05%
Primary Outcome Measure Information:
Title
To evaluate the safety of PEP005 Gel, 0.05% when administered for up to three consecutive days to Seborrhoeic Keratosis on non-head locations.
Time Frame
Day 43
Secondary Outcome Measure Information:
Title
To determine the efficacy of PEP005 Gel, 0.05% when administered for up to three consecutive days to Seborrhoeic Keratosis on non-head locations.
Time Frame
Day 43
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Patient is male or female and at least 18 years of age.
Female patients must be of either:
Non-childbearing potential, provided there is a laboratory confirmed serum follicle stimulating hormone (FSH) level ≥ 40mIU/ml or there is a confirmed clinical history of sterility (e.g., the patient is without a uterus); or
Childbearing potential, provided there are negative urine pregnancy test results prior to study treatment, to rule out pregnancy.
Patient has provided informed consent documented by signing the Informed Consent Form (ICF) prior to any study-related procedures, including any alteration of medications in preparation for study entry.
Patient has agreed to allow photographs of the selected treatment lesions to be taken and used as part of the study data package.
Exclusion Criteria
Known sensitivity or allergy to any of the ingredients in PEP005 (ingenol mebutate)Gel.
Current enrolment or participation in a clinical research study within 30 days of entry into this study.
Facility Information:
Facility Name
Southderm Pty Ltd
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Specialist Connect
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
12. IPD Sharing Statement
Links:
URL
http://www.peplin.com/
Description
Related Info
URL
http://www.tga.gov.au/
Description
Related Info
Learn more about this trial
Study to Evaluate the Safety and Efficacy of PEP005(Ingenol Mebutate) Gel, 0.05%, in Patients With Seborrhoeic Keratosis
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