Status:
COMPLETED
Safety and Dose Finding Study of New Vehicle Formulations Containing Ingenol Mebutate to Treat Actinic Keratosis on the Forearm
Lead Sponsor:
LEO Pharma
Conditions:
Actinic Keratosis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to determine if the new vehicle formulations containing ingenol mebutate are as safe and effective as Picato® gel 0.05% (it's current vehicle formulation) when applied to ...
Detailed Description
This study will be run in 2 parts. The first part involves applying escalating concentrations of the new vehicle formulations containing ingenol mebutate to AKs on the forearms. Reactions and safety w...
Eligibility Criteria
Inclusion
- Must be male or female and at least 18 years of age.
- Female patients must be of non-childbearing potential or if of childbearing potential then negative serum and urine pregnancy test and using effective contraception.
- Ability to provide informed consent.
Exclusion
- location of the selected treatment area within 5cm of an incompletely healed wound or within 5cm of a suspected basal cell carcinoma or squamous cell carcinoma
- undergone Cosmetic or therapeutic procedures within 2cm of the selected treatment area in the 2 weeks prior to the treatment visit
- presence of sunburn within the selected treatment areas
- use of acid-containing therapeutic products within 2cm of the selected treatment area in the 2 weeks prior to the treatment visit
- previous enrolment in this clinical trial
- prior treatment with ingenol mebutate on the forearms
- use of topical moisturisers/creams/lotions, artificial tanners or topical steroids within 2cm of the selected treatment areas in the 2 weeks prior to the treatment visit
- treatment with immunomodulators, or interferon/interferon inducers or systemic medications that suppress the immune system within 4 weeks of the treatment visit
- treatment with 5-FU, imiquimod, diclofenac,or photodynamic therapy within 2 cm of the treatment area in the 8 weeks prior to the treatment visit
- use of systemic retinoids
- those who are currently participating in any other clinical trial
- females who are pregnant or are breastfeeding
- those known or suspected or not being able to comply with the requirements of the protocol or provide consent
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT01803477
Start Date
February 1 2013
End Date
December 1 2013
Last Update
February 24 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Dermatology Department
Woolloongabba, Queensland, Australia, 4102
2
Specialist Connect
Woolloongabba, Queensland, Australia, 4102