A Study to Evaluate the Efficacy and Safety of Topical Administration of FMX101 in the Treatment of Moderate-to-Severe Acne Vulgaris
- Conditions
- Acne Vulgaris
- Interventions
- Drug: FMX101Drug: Vehicle Foam
- Registration Number
- NCT03271021
- Lead Sponsor
- Vyne Therapeutics Inc.
- Brief Summary
A Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Efficacy and Safety of Topical Administration of FMX101 for 12 Weeks in the Treatment of Moderate-to-Severe Acne Vulgaris (Study FX2017-22)
- Detailed Description
This is a randomized, multicenter, double-blind, vehicle-controlled, 2 arm study to evaluate the safety and efficacy over 12 weeks of FMX101 topical foam containing 4% minocycline compared to vehicle in the treatment of subjects with moderate-to-severe facial acne vulgaris. Qualified subjects will be randomized to receive 1 of the following 2 treatments:
* FMX101 4% minocycline foam
* Vehicle foam
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1488
-
Has facial acne vulgaris with:
- 20 to 50 inflammatory lesions (papules, pustules, and nodules)
- 25 to 100 non-inflammatory lesions (open and closed comedones)
- No more than 2 nodules on the face
- 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.
- Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne), or any dermatological condition of the face or facial hair (eg, beard, sideburns, mustache) that could interfere with the clinical evaluations.
- Sunburn on the face.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description FMX101, 4% minocycline foam FMX101 FMX101, 4% minocycline foam applied topically once daily for 12 weeks Vehicle foam Vehicle Foam Vehicle foam applied topically once daily for 12 weeks
- Primary Outcome Measures
Name Time Method The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 12. 12 weeks A decrease in the inflammatory lesion count from Baseline to Week 12.
Investigator Global Assessment (IGA) Treatment Success (Dichotomized as Yes/no) at Week 12, Where Success is Defined as an IGA Score of 0 or 1, and at Least a 2-grade Improvement (Decrease) From Baseline 12 weeks
- Secondary Outcome Measures
Name Time Method The Absolute Change From Baseline in the Non-inflammatory Lesion Count at Week 12 12 weeks IGA Treatment Success (Dichotomized as Yes/no) at Week 9, Where Success is Defined as an IGA Score of 0 or 1, and at Least a 2-grade Improvement (Decrease) From Baseline at the Interim Visit at Week 9 9 weeks The Absolute Change From Baseline in the Inflammatory Lesion Count at the Interim Visit at Week 6 6 weeks The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 9 9 weeks IGA Treatment Success (Dichotomized as Yes/no) at Week 6, Where Success is Defined as an IGA Score of 0 or 1, and at Least a 2-grade Improvement (Decrease) From Baseline at the Interim Visit at Week 6 6 weeks
Trial Locations
- Locations (97)
Foamix Investigational Site #403
🇺🇸Los Angeles, California, United States
Foamix Investigational Site #330
🇺🇸Dublin, Ohio, United States
Foamix Investigational Site #340
🇺🇸Fort Smith, Arkansas, United States
Foamix Investigational Site #375
🇺🇸Temecula, California, United States
Foamix Investigational Site #381
🇺🇸Aventura, Florida, United States
Foamix Investigational Site #303
🇺🇸Murrieta, California, United States
Foamix Investigational Site #387
🇺🇸Palm Springs, California, United States
Foamix Investigational Site #336
🇺🇸Sandy Springs, Georgia, United States
Foamix Investigational Site #369
🇺🇸Northridge, California, United States
Foamix Investigational Site #380
🇺🇸Poway, California, United States
Foamix Investigational Site #396
🇺🇸DeLand, Florida, United States
Foamix Investigational Site #311
🇺🇸Boca Raton, Florida, United States
Foamix Investigational Site #347
🇺🇸Miami Lakes, Florida, United States
Foamix Investigational Site # 328
🇺🇸Sacramento, California, United States
Foamix Investigational Site #394
🇺🇸Tampa, Florida, United States
Foamix Investigational SIte #377
🇺🇸Little Rock, Arkansas, United States
Foamix Investigational Site #393
🇺🇸Pasadena, California, United States
Foamix Investigational Site #318
🇺🇸Fort Myers, Florida, United States
Foamix Investigational SIte #382
🇺🇸Tamarac, Florida, United States
Foamix Investigational Site #378
🇺🇸Davie, Florida, United States
Foamix Investigational Site #325
🇺🇸Santa Monica, California, United States
Foamix Investigational Site #334
🇺🇸Watertown, Massachusetts, United States
Foamix Investigational Site #361
🇺🇸Plainfield, Indiana, United States
Foamix Investigational Site #401
🇺🇸Hialeah, Florida, United States
Foamix Investigational Site #309
🇺🇸Santa Ana, California, United States
Foamix Investigational Site #346
🇺🇸Miami Lakes, Florida, United States
Foamix Investigational Site #307
🇺🇸Stony Brook, New York, United States
Foamix Investigational Site #344
🇺🇸Portsmouth, New Hampshire, United States
Foamix Investigational Site #384
🇺🇸Nampa, Idaho, United States
Foamix Investigational Site #322
🇺🇸Saint Joseph, Missouri, United States
Foamix Investigational Site #304
🇺🇸Beverly, Massachusetts, United States
Foamix Investigational Site #331
🇺🇸South Bend, Indiana, United States
Foamix Investigational Site #312
🇺🇸Ormond Beach, Florida, United States
Foamix Investigational Site #314
🇺🇸Brighton, Massachusetts, United States
Foamix Investigational Site #391
🇺🇸Lincoln, Nebraska, United States
Foamix Investigational SIte #373
🇺🇸New Orleans, Louisiana, United States
Foamix Investigational Site #316
🇺🇸New Albany, Indiana, United States
Foamix Investigational Site #335
🇺🇸Exton, Pennsylvania, United States
Foamix Investigational Site #310
🇺🇸Bexley, Ohio, United States
Foamix Investigational Site #355
🇺🇸New York, New York, United States
Foamix Investigational Site #337
🇺🇸Verona, New Jersey, United States
Foamix Investigational Site #321
🇺🇸Charlotte, New York, United States
Foamix Investigational Site #348
🇺🇸Winston-Salem, North Carolina, United States
Foamix Investigational SIte #341
🇺🇸Austin, Texas, United States
Foamix Investigational Site #397
🇺🇸Miami, Florida, United States
Foamix Investigational Site #370
🇺🇸Miami, Florida, United States
Foamix Investigational Site #365
🇺🇸Indianapolis, Indiana, United States
Foamix Investigational Site #333
🇺🇸Houston, Texas, United States
Foamix Investigational Site #352
🇺🇸Houston, Texas, United States
Foamix Investigational Site #313
🇺🇸San Diego, California, United States
Foamix Investigational Site #332
🇺🇸Las Vegas, Nevada, United States
Foamix Investigational Site #386
🇺🇸Cincinnati, Ohio, United States
Foamix Investigational Site #388
🇺🇸Glenn Dale, Maryland, United States
Foamix Investigational Site #376
🇺🇸Phoenix, Arizona, United States
Foamix Investigational Site #400
🇺🇸Hialeah, Florida, United States
Foamix Investigational Site #360
🇺🇸West Palm Beach, Florida, United States
Foamix Investigational Site #395
🇺🇸Tucson, Arizona, United States
Foamix Investigational Site #315
🇺🇸Bryant, Arkansas, United States
Foamix Investigational Site #366
🇺🇸Encino, California, United States
Foamix Investigational Site #329
🇺🇸Clearwater, Florida, United States
Foamix Investigational Site #398
🇺🇸Brandon, Florida, United States
Foamix Investigational SIte #371
🇺🇸Boca Raton, Florida, United States
Foamix Investigational Site #392
🇺🇸Doral, Florida, United States
Foamix Investigational Site #383
🇺🇸Lake Worth, Florida, United States
Foamix Investigational Site #390
🇺🇸West Dundee, Illinois, United States
Foamix Investigational Site #306
🇺🇸North Miami Beach, Florida, United States
Foamix Investigational Site #399
🇺🇸Tampa, Florida, United States
Foamix Investigational Site #362
🇺🇸South Miami, Florida, United States
Foamix Investigational Site #368
🇺🇸Columbus, Georgia, United States
Foamix Investigational Site #385
🇺🇸Tampa, Florida, United States
Foamix Investigational Site #345
🇺🇸Skokie, Illinois, United States
Foamix Investigational Site #320
🇺🇸Louisville, Kentucky, United States
Foamix Investigational Site #317
🇺🇸New Orleans, Louisiana, United States
Foamix Investigational SIte #367
🇺🇸Louisville, Kentucky, United States
Foamix Investigational Site #350
🇺🇸Charlotte, North Carolina, United States
Foamix Investigational Site #356
🇺🇸Berlin, New Jersey, United States
Foamix Investigational Site # 327
🇺🇸Omaha, Nebraska, United States
Foamix Investigational Site #372
🇺🇸Saint Louis, Missouri, United States
Foamix Investigational Site #363
🇺🇸New York, New York, United States
Foamix Investigational Site #353
🇺🇸Cleveland, Ohio, United States
Foamix Investigational Site #364
🇺🇸Fargo, North Dakota, United States
Foamix Investigational Site #302
🇺🇸Norman, Oklahoma, United States
Foamix Investigational Site #323
🇺🇸Jenkintown, Pennsylvania, United States
Foamix Investigational Site #308
🇺🇸Knoxville, Tennessee, United States
Foamix Investigational Site #349
🇺🇸Hershey, Pennsylvania, United States
Foamix Investigational Site #305
🇺🇸Mount Pleasant, South Carolina, United States
Foamix Research Site # 301
🇺🇸Arlington, Texas, United States
Foamix Investigational Site #374
🇺🇸Arlington, Texas, United States
Foamix Investigational Site #351
🇺🇸Austin, Texas, United States
Foamix Investigational Site #343
🇺🇸Norfolk, Virginia, United States
Foamix Investigational Site #402
🇺🇸Bryan, Texas, United States
Foamix Investigational Site #358
🇺🇸Dallas, Texas, United States
Foamix Investigational Site # 324
🇺🇸Pflugerville, Texas, United States
Foamix Investigational SIte #379
🇺🇸Lynchburg, Virginia, United States
Foamix Investigational Site #389
🇺🇸Seattle, Washington, United States
Foamix Investigational Site #359
🇺🇸Tacoma, Washington, United States
Foamix Investigational Site #319
🇺🇸Charleston, South Carolina, United States