Safety and Efficacy of Escalating Doses of LEO 43204 Applied Once Daily for Two Consecutive Days on Approximately 250 cm2 on Trunk and Extremities in Subjects With Actinic Keratosis
NCT ID: NCT02120456
Last Updated: 2025-03-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
224 participants
INTERVENTIONAL
2014-05-31
2015-05-31
Brief Summary
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Part 2: To evaluate the efficacy of LEO 43204 in two doses after once daily treatment for two consecutive days compared to vehicle
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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
Open-label, dose-escalation, 2-day treatment
LEO 43204
LEO 43204 Dose 0.1%
LEO 43204 dose 0.1% once daily for two consecutive days
LEO 43204
LEO 43204 Dose 0.075%
LEO 43204 dose 0.075% once daily for two days
LEO 43204
Placebo
Placebo once daily for two days
Placebo
Interventions
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LEO 43204
Placebo
Eligibility Criteria
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Inclusion Criteria
* Part 2: Subjects with 5 to 20 clinically typical, visible and discrete AKs on the extremities or trunk
Exclusion Criteria
* within 5 cm of an incompletely healed wound
* within 5 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC)
* Prior treatment with ingenol mebutate gel on the treatment area
* Lesions in the treatment areas that have:
* atypical clinical appearance (e.g., hypertrophic, hyperkeratotic or cutaneous horns) and/or
* recalcitrant disease (e.g., did not respond to cryotherapy on two previous occasions)
18 Years
ALL
No
Sponsors
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LEO Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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Gary Goldenberg, MD
Role: PRINCIPAL_INVESTIGATOR
Mount Sinai School of Medicine, Dermatology Faculty
Locations
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Omni Dermatology
Phoenix, Arizona, United States
Torrance Clinical Research Institute Inc.
Lomita, California, United States
Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.
San Diego, California, United States
Dermatology Associates and Research
Coral Gables, Florida, United States
Leavitt Medical Associates of Florida
Ormond Beach, Florida, United States
Deaconess Clinic, Inc.
Evansville, Indiana, United States
Hudson Dermatology, LLC
Evansville, Indiana, United States
Indiana Clinical Trials Center
Plainfield, Indiana, United States
DermAssociates, PC
Rockville, Maryland, United States
Great Lakes Research Group, Inc.
Bay City, Michigan, United States
The Dermatology Group, P.C.
Verona, New Jersey, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Pflugerville Dermatology Clinical Research Center, Inc.
Pflugerville, Texas, United States
Kirk Barber Research
Calgary, Alberta, Canada
Enverus Medical
Surrey, British Columbia, Canada
Skin Care Centre
Vancouver, British Columbia, Canada
Winnipeg Clinic Dermatology Research
Winnipeg, Manitoba, Canada
UltraNova Skincare
Barrie, Ontario, Canada
Dermatrials Research Incorporated
Hamilton, Ontario, Canada
The Guenther Dermatology Research Centre
London, Ontario, Canada
SKiN Centre for Dermatology
Peterborough, Ontario, Canada
Countries
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Related Links
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Clinical Trials at LEO Pharma
Other Identifiers
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LP0084-1015
Identifier Type: -
Identifier Source: org_study_id
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