Status:
COMPLETED
Histological Confirmation of Clinical Clearance of Actinic Keratoses Following Treatment With Ingenol Mebutate Gel, 0.05%
Lead Sponsor:
LEO Pharma
Conditions:
Actinic Keratosis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The main purpose of this trial is to demonstrate the predictive value of the clinical diagnosis of clearance of Actinic Keratoses after treatment with Ingenol Mebutate using histopathological examinat...
Eligibility Criteria
Inclusion
- Must be male or female and at least 18 years of age.
- Female patients must be on non-childbearing potential or if of childbearing potential then negative serum and urine pregnancy test and using effective contraception
- Ability to provide informed consent
- Subjects must have 5-9 clinically typical, visible and discrete AK lesions within a contiguous 25cm2 treatment area on the trunk and extremities except the back of the hand
- AK should be confirmed by histopathology of one of the AK's prior to inclusion
Exclusion
- location of the selected treatment area within 5cm of an incompletely healed wound or within 10cm of a suspected basal cell carcinoma or squamous cell carcinoma
- undergone Cosmetic or therapeutic procedures
- use of acid-containing therapeutic products within 2cm of the selected treatment area in the 2 weeks prior to Visit 1
- use of topical creams/lotions, artificial tanners or topical steroids within 2cm of the selected treatment areas in the 2 weeks prior to visit 1.
- treatment with immunomodulators, or interferon/interferon inducers or systemic medications that suppress the immune system within 4 weeks of visit 1
- treatment with 5-FU, imiquimod, diclofenac, ingenol mebutate of photodynamic therapy within 2cm of the treatment area in the 8 weeks prior to visit 1
- use of systemic retinoids
- those who are currently participating in any other interventional clinical trial
- females who are pregnant or are breastfeeding
- those known or suspected of not being able to comply with the requirements of the protocol or provide consent
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
137 Patients enrolled
Trial Details
Trial ID
NCT01892137
Start Date
July 1 2013
End Date
May 1 2014
Last Update
February 24 2025
Active Locations (10)
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1
Southderm Pty Ltd
Kogarah, New South Wales, Australia, 2217
2
Melanoma Institute Australia
North Sydney, New South Wales, Australia, 2060
3
The Skin Centre
Benowa, Queensland, Australia, 4217
4
South East Dermatology Centre
Carina Heights, Queensland, Australia, 4152