Status:
COMPLETED
Study to Evaluate the Safety and Efficacy of PEP005(Ingenol Mebutate) Gel, 0.05%, in Patients With Seborrhoeic Keratosis
Lead Sponsor:
Peplin
Conditions:
Seborrheic Keratosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 Se...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01214564
Start Date
October 1 2010
End Date
December 1 2010
Last Update
January 25 2011
Active Locations (2)
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1
Southderm Pty Ltd
Kogarah, New South Wales, Australia, 2217
2
Specialist Connect
Woolloongabba, Queensland, Australia, 4102