Safety and Tolerability of Different Concentrations of an Ingenol Derivative Field Therapy in the Treatment of Actinic Keratosis
NCT ID: NCT01703078
Last Updated: 2025-02-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
41 participants
INTERVENTIONAL
2012-11-30
2013-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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Ingenol mebutate gel 0.05%
once daily for two consecutive days
Ingenol once daily for two consecutive days
Ingenol derivative concentration 1
once daily for two consecutive days
Ingenol once daily for two consecutive days
Ingenol derivative concentration 2
once daily for two consecutive days
Ingenol once daily for two consecutive days
Ingenol derivative concentration 3
once daily for two consecutive days
Ingenol once daily for two consecutive days
Interventions
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Ingenol once daily for two consecutive days
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* undergone Cosmetic or therapeutic procedures within 2cm of the selected treatment area in the 2 weeks prior to Visit 2
* use of acid-containing therapeutic products within 2cm of the selected treatment area in the 2 weeks prior to Visit 2
* use of topical moisturisers/creams/lotions, artificial tanners or topical steroids within 2cm of the selected treatment areas in the 2 weeks prior to visit 2 Treatment with immunomodulators, or interferon/interferon inducers or systemic medications that suppress the immune system within 4 weeks of Visit 2
* Treatment with 5-FU, imiquimod, diclofenac, or photodynamic therapy within 2 cm of the treatment area in the 8 weeks prior to visit 2
* 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 of not being able to comply with the requirements of the protocol or provide consent
18 Years
ALL
No
Sponsors
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LEO Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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Hans P Soyer
Role: PRINCIPAL_INVESTIGATOR
Dermatology Department, Brisbane Public Hospital
Locations
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Dermatology Department
Woolloongabba, Queensland, Australia
Countries
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Related Links
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LEO Pharma
Therapeutic Goods Administration
Other Identifiers
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LP0084-68
Identifier Type: -
Identifier Source: org_study_id
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