A Study to Compare the Efficacy and Safety of Topical Administration of FMX-101 for Treatment of Moderate-to-Severe Acne
NCT ID: NCT02815267
Last Updated: 2022-01-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
466 participants
INTERVENTIONAL
2016-05-31
2017-10-13
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
DOUBLE
Study Groups
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FMX-101, 4% minocycline foam
Subjects will apply the assigned FMX-101, 4% minocycline foam topically once daily for 12 weeks as directed
FMX-101, 4% minocycline foam
FMX-101, 4% minocycline foam applied topically once daily for 12 weeks
Vehicle foam
Subjects will apply the assigned vehicle foam topically once daily for 12 weeks as directed
Vehicle Foam
Vehicle foam applied topically once daily for 12 weeks
Interventions
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FMX-101, 4% minocycline foam
FMX-101, 4% minocycline foam applied topically once daily for 12 weeks
Vehicle Foam
Vehicle foam applied topically once daily for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* 20 to 50 inflammatory lesions (papules, pustules, and nodules);
* 25 to 100 noninflammatory lesions (open and closed comedones);
* no more than 2 nodules on the face; and
* IGA score of moderate (3) to severe (4)
* Willing to use only the supplied non-medicated cleanser (Cetaphil Gentle Skin Cleanser) and to refrain from use of any other acne medication, medicated cleanser, excessive sun exposure, and tanning booths for the duration of the study
Exclusion Criteria
* Sunburn on the face
* Severe systemic disease, which might interfere with the conduct of the study or the interpretation of the results.
* Abnormal baseline laboratory values that are considered clinically significant
* Allergy to tetracycline-class antibiotics or to any ingredient in the study drug
* Pseudomembranous colitis or antibiotic-associated colitis
9 Years
ALL
No
Sponsors
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Vyne Therapeutics Inc.
INDUSTRY
Responsible Party
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Locations
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Birmingham, Alabama, United States
Fremont, California, United States
Fullerton, California, United States
Shelton, Connecticut, United States
Washington D.C., District of Columbia, United States
Boynton Beach, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miramar, Florida, United States
Sanford, Florida, United States
Savannah, Georgia, United States
Oakbrook Terrace, Illinois, United States
Evansville, Indiana, United States
Metairie, Louisiana, United States
Rockville, Maryland, United States
Bay City, Michigan, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
New York, New York, United States
New York, New York, United States
High Point, North Carolina, United States
Columbus, Ohio, United States
Gresham, Oregon, United States
Johnston, Rhode Island, United States
Murfreesboro, Tennessee, United States
Dallas, Texas, United States
Plano, Texas, United States
San Antonio, Texas, United States
West Jordan, Utah, United States
Bridgeport, West Virginia, United States
San Cristóbal, , Dominican Republic
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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FX2014-04
Identifier Type: -
Identifier Source: org_study_id
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