Efficacy and Safety of LEO 43204 in the Field Treatment of Actinic Keratosis on Face or Chest including12-month Follow-up
NCT ID: NCT02549339
Last Updated: 2025-03-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
383 participants
INTERVENTIONAL
2015-11-13
2017-08-10
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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LEO 43204 gel
Treatment once daily for 3 days
LEO 43204 gel
Vehicle gel
Treatment once daily for 3 days
Vehicle gel
Interventions
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LEO 43204 gel
Vehicle gel
Eligibility Criteria
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Inclusion Criteria
* Subjects with minimum 3 clinically typical, visible and discrete AKs within a tracking area of 50 cm2 (8 in2). The tracking area must be within the treatment area
Exclusion Criteria
* Treatment with ingenol mebutate gel in the treatment area within the last 12 months
* Lesions in the treatment area that have: atypical clinical appearance (e.g. hyperthrophic, hyperkeratotic or cutaneous horns) and /or, recalcitrant disease (e.g. did not respond to cryotherapy on two previous occasions)
* History or evidence of skin conditions other than the trial indication that would interfere with the evaluation of the trial medication (e.g., eczema, unstable psoriasis, xeroderma pigmentosum)
18 Years
ALL
No
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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Related Links
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Clinical Trials at LEO Pharma
Other Identifiers
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LP0084-1194
Identifier Type: -
Identifier Source: org_study_id
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