Efficacy and Safety of Ingenol Mebutate Gel for Actinic Keratosis Applied on Large Area on Face, Scalp or Chest
NCT ID: NCT02361216
Last Updated: 2025-03-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
729 participants
INTERVENTIONAL
2015-04-30
2017-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ingenol mebutate gel
Treatment once daily for 3 days
Ingenol Mebutate
Vehicle
Treatment once daily for 3 days
Vehicle
Vehicle gel
Interventions
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Ingenol Mebutate
Vehicle
Vehicle gel
Eligibility Criteria
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Inclusion Criteria
* The full face
* The full balding scalp
* A contiguous area of approximately 250 cm2 on the chest
Exclusion Criteria
* Previously assigned treatment in this clinical trial or previously participated in a clinical trial in the LEO clinical programme on ingenol mebutate gel for larger treatment areas.
* Treatment with ingenol mebutate gel in the selected treatment area within the last 12 months.
* Lesions in the treatment area that have: atypical clinical appearance (e.g. cutaneous horn) and/or, recalcitrant disease (e.g., did not respond to cryotherapy on two previous occasions).
18 Years
ALL
Yes
Sponsors
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LEO Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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C. William Hanke, MD
Role: PRINCIPAL_INVESTIGATOR
Laser & Skin Surgery Center of Indiana,
Locations
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Laser & Skin Surgery Center of Indiana
Carmel, Indiana, United States
Countries
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Other Identifiers
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LP0105-1032
Identifier Type: -
Identifier Source: org_study_id
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