A Study to Evaluate the Efficacy and Safety of Topical Administration of FMX101 in the Treatment of Moderate-to-Severe Acne Vulgaris
NCT ID: NCT03271021
Last Updated: 2022-01-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1488 participants
INTERVENTIONAL
2017-07-17
2018-09-04
Brief Summary
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Detailed Description
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* FMX101 4% minocycline foam
* Vehicle foam
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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FMX101, 4% minocycline foam
FMX101, 4% minocycline foam applied topically once daily for 12 weeks
FMX101
FMX101, 4% minocycline foam
Vehicle foam
Vehicle foam applied topically once daily for 12 weeks
Vehicle Foam
Vehicle Foam
Interventions
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FMX101
FMX101, 4% minocycline foam
Vehicle Foam
Vehicle Foam
Eligibility Criteria
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Inclusion Criteria
1. 20 to 50 inflammatory lesions (papules, pustules, and nodules)
2. 25 to 100 non-inflammatory lesions (open and closed comedones)
3. No more than 2 nodules on the face
4. IGA score of moderate (3) to severe (4)
2. 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
2. Sunburn on the face.
9 Years
ALL
No
Sponsors
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Vyne Therapeutics Inc.
INDUSTRY
Responsible Party
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Locations
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Foamix Investigational Site #376
Phoenix, Arizona, United States
Foamix Investigational Site #395
Tucson, Arizona, United States
Foamix Investigational Site #315
Bryant, Arkansas, United States
Foamix Investigational Site #340
Fort Smith, Arkansas, United States
Foamix Investigational SIte #377
Little Rock, Arkansas, United States
Foamix Investigational Site #366
Encino, California, United States
Foamix Investigational Site #403
Los Angeles, California, United States
Foamix Investigational Site #303
Murrieta, California, United States
Foamix Investigational Site #369
Northridge, California, United States
Foamix Investigational Site #387
Palm Springs, California, United States
Foamix Investigational Site #393
Pasadena, California, United States
Foamix Investigational Site #380
Poway, California, United States
Foamix Investigational Site # 328
Sacramento, California, United States
Foamix Investigational Site #313
San Diego, California, United States
Foamix Investigational Site #336
San Luis Obispo, California, United States
Foamix Investigational Site #309
Santa Ana, California, United States
Foamix Investigational Site #325
Santa Monica, California, United States
Foamix Investigational Site #375
Temecula, California, United States
Foamix Investigational Site #381
Aventura, Florida, United States
Foamix Investigational SIte #371
Boca Raton, Florida, United States
Foamix Investigational Site #311
Boca Raton, Florida, United States
Foamix Investigational Site #398
Brandon, Florida, United States
Foamix Investigational Site #329
Clearwater, Florida, United States
Foamix Investigational Site #378
Davie, Florida, United States
Foamix Investigational Site #396
DeLand, Florida, United States
Foamix Investigational Site #392
Doral, Florida, United States
Foamix Investigational Site #318
Fort Myers, Florida, United States
Foamix Investigational Site #401
Hialeah, Florida, United States
Foamix Investigational Site #400
Hialeah, Florida, United States
Foamix Investigational Site #383
Lake Worth, Florida, United States
Foamix Investigational Site #397
Miami, Florida, United States
Foamix Investigational Site #370
Miami, Florida, United States
Foamix Investigational Site #346
Miami Lakes, Florida, United States
Foamix Investigational Site #347
Miami Lakes, Florida, United States
Foamix Investigational Site #306
North Miami Beach, Florida, United States
Foamix Investigational Site #312
Ormond Beach, Florida, United States
Foamix Investigational Site #362
South Miami, Florida, United States
Foamix Investigational SIte #382
Tamarac, Florida, United States
Foamix Investigational Site #399
Tampa, Florida, United States
Foamix Investigational Site #385
Tampa, Florida, United States
Foamix Investigational Site #394
Tampa, Florida, United States
Foamix Investigational Site #360
West Palm Beach, Florida, United States
Foamix Investigational Site #368
Columbus, Georgia, United States
Foamix Investigational Site #336
Sandy Springs, Georgia, United States
Foamix Investigational Site #384
Nampa, Idaho, United States
Foamix Investigational Site #345
Skokie, Illinois, United States
Foamix Investigational Site #390
West Dundee, Illinois, United States
Foamix Investigational Site #365
Indianapolis, Indiana, United States
Foamix Investigational Site #316
New Albany, Indiana, United States
Foamix Investigational Site #361
Plainfield, Indiana, United States
Foamix Investigational Site #331
South Bend, Indiana, United States
Foamix Investigational Site #320
Louisville, Kentucky, United States
Foamix Investigational SIte #367
Louisville, Kentucky, United States
Foamix Investigational Site #317
New Orleans, Louisiana, United States
Foamix Investigational SIte #373
New Orleans, Louisiana, United States
Foamix Investigational Site #388
Glenn Dale, Maryland, United States
Foamix Investigational Site #304
Beverly, Massachusetts, United States
Foamix Investigational Site #314
Brighton, Massachusetts, United States
Foamix Investigational Site #334
Watertown, Massachusetts, United States
Foamix Investigational Site #322
Saint Joseph, Missouri, United States
Foamix Investigational Site #372
St Louis, Missouri, United States
Foamix Investigational Site #391
Lincoln, Nebraska, United States
Foamix Investigational Site # 327
Omaha, Nebraska, United States
Foamix Investigational Site #332
Las Vegas, Nevada, United States
Foamix Investigational Site #344
Portsmouth, New Hampshire, United States
Foamix Investigational Site #356
Berlin, New Jersey, United States
Foamix Investigational Site #337
Verona, New Jersey, United States
Foamix Investigational Site #321
Charlotte, New York, United States
Foamix Investigational Site #355
New York, New York, United States
Foamix Investigational Site #363
New York, New York, United States
Foamix Investigational Site #307
Stony Brook, New York, United States
Foamix Investigational Site #350
Charlotte, North Carolina, United States
Foamix Investigational Site #348
Winston-Salem, North Carolina, United States
Foamix Investigational Site #364
Fargo, North Dakota, United States
Foamix Investigational Site #310
Bexley, Ohio, United States
Foamix Investigational Site #386
Cincinnati, Ohio, United States
Foamix Investigational Site #353
Cleveland, Ohio, United States
Foamix Investigational Site #330
Dublin, Ohio, United States
Foamix Investigational Site #302
Norman, Oklahoma, United States
Foamix Investigational Site #335
Exton, Pennsylvania, United States
Foamix Investigational Site #349
Hershey, Pennsylvania, United States
Foamix Investigational Site #323
Jenkintown, Pennsylvania, United States
Foamix Investigational Site #319
Charleston, South Carolina, United States
Foamix Investigational Site #305
Mt. Pleasant, South Carolina, United States
Foamix Investigational Site #308
Knoxville, Tennessee, United States
Foamix Research Site # 301
Arlington, Texas, United States
Foamix Investigational Site #374
Arlington, Texas, United States
Foamix Investigational SIte #341
Austin, Texas, United States
Foamix Investigational Site #351
Austin, Texas, United States
Foamix Investigational Site #402
Bryan, Texas, United States
Foamix Investigational Site #358
Dallas, Texas, United States
Foamix Investigational Site #333
Houston, Texas, United States
Foamix Investigational Site #352
Houston, Texas, United States
Foamix Investigational Site # 324
Pflugerville, Texas, United States
Foamix Investigational SIte #379
Lynchburg, Virginia, United States
Foamix Investigational Site #343
Norfolk, Virginia, United States
Foamix Investigational Site #389
Seattle, Washington, United States
Foamix Investigational Site #359
Tacoma, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Related Info
Other Identifiers
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FX2017-22
Identifier Type: -
Identifier Source: org_study_id
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