Study to Evaluate the Safety and Efficacy of PEP005(Ingenol Mebutate) Gel, 0.05%, in Patients With Seborrhoeic Keratosis
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
1 other identifier
interventional
24
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Oct 2010
Shorter than P25 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 3, 2010
CompletedFirst Posted
Study publicly available on registry
October 5, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedJanuary 25, 2011
January 1, 2011
2 months
October 3, 2010
January 23, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the safety of PEP005 Gel, 0.05% when administered for up to three consecutive days to Seborrhoeic Keratosis on non-head locations.
Day 43
Secondary Outcomes (1)
To determine the efficacy of PEP005 Gel, 0.05% when administered for up to three consecutive days to Seborrhoeic Keratosis on non-head locations.
Day 43
Study Arms (1)
1
EXPERIMENTALUp to three days of treatment
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Peplinlead
Study Sites (2)
Southderm Pty Ltd
Kogarah, New South Wales, 2217, Australia
Specialist Connect
Woolloongabba, Queensland, 4102, Australia
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 3, 2010
First Posted
October 5, 2010
Study Start
October 1, 2010
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
January 25, 2011
Record last verified: 2011-01