Status:
COMPLETED
Study to Evaluate the Safety and Efficacy of PEP005 (Ingenol Mebutate) Gel, 0.015%, in Patients With Photo-damaged Skin
Lead Sponsor:
Peplin
Conditions:
Photo-damage
Eligibility:
All Genders
30-65 years
Phase:
PHASE2
Brief Summary
This study is primarily designed to evaluate the safety and tolerability of PEP005 Gel, 0.015% when administered for up to three consecutive days to photo-damaged skin on the face. The secondary endpo...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Male and female patients aged 30 to 65 years.
- 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 area 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 :
January 1 2011
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01214577
Start Date
October 1 2010
End Date
January 1 2011
Last Update
January 25 2011
Active Locations (2)
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1
The Skin Centre
Benowa, Queensland, Australia, 4217
2
Specialist Connect
Woolloongabba, Queensland, Australia, 4102