Clinical trial NCT03271021: A Study to Evaluate the Efficacy and Safety of Topical Administration of FMX101 in the Treatment of Moderate-to-Severe Acne Vulgaris
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acne Vulgaris
Lead sponsor: Vyne Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2017-09-01
Enrollment: 1488
Sex: ALL
Minimum age (years): 9
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: Inclusion Criteria:

1. Has facial acne vulgaris with:

   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:

1. 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.
2. Sunburn on the face.

Primary outcomes:
measure: The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 12.
timeFrame: 12 weeks
measure: 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
timeFrame: 12 weeks
Secondary outcomes:
measure: The Absolute Change From Baseline in the Non-inflammatory Lesion Count at Week 12
timeFrame: 12 weeks
measure: The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 9
timeFrame: 9 weeks
measure: The Absolute Change From Baseline in the Inflammatory Lesion Count at the Interim Visit at Week 6
timeFrame: 6 weeks
measure: 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
timeFrame: 6 weeks
measure: 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
timeFrame: 9 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Foamix Investigational Site #376
state: Arizona
city: Tucson
country: United States
facility: Foamix Investigational Site #395
state: Arizona
city: Bryant
country: United States
facility: Foamix Investigational Site #315
state: Arkansas
city: Fort Smith
country: United States
facility: Foamix Investigational Site #340
state: Arkansas
city: Little Rock
country: United States
facility: Foamix Investigational SIte #377
state: Arkansas
city: Encino
country: United States
facility: Foamix Investigational Site #366
state: California
city: Los Angeles
country: United States
facility: Foamix Investigational Site #403
state: California
city: Murrieta
country: United States
facility: Foamix Investigational Site #303
state: California
city: Northridge
country: United States
facility: Foamix Investigational Site #369
state: California
city: Palm Springs
country: United States
facility: Foamix Investigational Site #387
state: California
city: Pasadena
country: United States
facility: Foamix Investigational Site #393
state: California
city: Poway
country: United States
facility: Foamix Investigational Site #380
state: California
city: Sacramento
country: United States
facility: Foamix Investigational Site # 328
state: California
city: San Diego
country: United States
facility: Foamix Investigational Site #313
state: California
city: San Luis Obispo
country: United States
facility: Foamix Investigational Site #336
state: California
city: Santa Ana
country: United States
facility: Foamix Investigational Site #309
state: California
city: Santa Monica
country: United States
facility: Foamix Investigational Site #325
state: California
city: Temecula
country: United States
facility: Foamix Investigational Site #375
state: California
city: Aventura
country: United States
facility: Foamix Investigational Site #381
state: Florida
city: Boca Raton
country: United States
facility: Foamix Investigational SIte #371
state: Florida
city: Boca Raton
country: United States
facility: Foamix Investigational Site #311
state: Florida
city: Brandon
country: United States
facility: Foamix Investigational Site #398
state: Florida
city: Clearwater
country: United States
facility: Foamix Investigational Site #329
state: Florida
city: Davie
country: United States
facility: Foamix Investigational Site #378
state: Florida
city: DeLand
country: United States
facility: Foamix Investigational Site #396
state: Florida
city: Doral
country: United States
facility: Foamix Investigational Site #392
state: Florida
city: Fort Myers
country: United States
facility: Foamix Investigational Site #318
state: Florida
city: Hialeah
country: United States
facility: Foamix Investigational Site #401
state: Florida
city: Hialeah
country: United States
facility: Foamix Investigational Site #400
state: Florida
city: Lake Worth
country: United States
facility: Foamix Investigational Site #383
state: Florida
city: Miami Lakes
country: United States
facility: Foamix Investigational Site #346
state: Florida
city: Miami Lakes
country: United States
facility: Foamix Investigational Site #347
state: Florida
city: Miami
country: United States
facility: Foamix Investigational Site #397
state: Florida
city: Miami
country: United States
facility: Foamix Investigational Site #370
state: Florida
city: North Miami Beach
country: United States
facility: Foamix Investigational Site #306
state: Florida
city: Ormond Beach
country: United States
facility: Foamix Investigational Site #312
state: Florida
city: South Miami
country: United States
facility: Foamix Investigational Site #362
state: Florida
city: Tamarac
country: United States
facility: Foamix Investigational SIte #382
state: Florida
city: Tampa
country: United States
facility: Foamix Investigational Site #399
state: Florida
city: Tampa
country: United States
facility: Foamix Investigational Site #385
state: Florida
city: Tampa
country: United States
facility: Foamix Investigational Site #394
state: Florida
city: West Palm Beach
country: United States
facility: Foamix Investigational Site #360
state: Florida
city: Columbus
country: United States
facility: Foamix Investigational Site #368
state: Georgia
city: Sandy Springs
country: United States
facility: Foamix Investigational Site #336
state: Georgia
city: Nampa
country: United States
facility: Foamix Investigational Site #384
state: Idaho
city: Skokie
country: United States
facility: Foamix Investigational Site #345
state: Illinois
city: West Dundee
country: United States
facility: Foamix Investigational Site #390
state: Illinois
city: Indianapolis
country: United States
facility: Foamix Investigational Site #365
state: Indiana
city: New Albany
country: United States
facility: Foamix Investigational Site #316
state: Indiana
city: Plainfield
country: United States
facility: Foamix Investigational Site #361
state: Indiana
city: South Bend
country: United States
facility: Foamix Investigational Site #331
state: Indiana
city: Louisville
country: United States
facility: Foamix Investigational Site #320
state: Kentucky
city: Louisville
country: United States
facility: Foamix Investigational SIte #367
state: Kentucky
city: New Orleans
country: United States
facility: Foamix Investigational Site #317
state: Louisiana
city: New Orleans
country: United States
facility: Foamix Investigational SIte #373
state: Louisiana
city: Glenn Dale
country: United States
facility: Foamix Investigational Site #388
state: Maryland
city: Beverly
country: United States
facility: Foamix Investigational Site #304
state: Massachusetts
city: Brighton
country: United States
facility: Foamix Investigational Site #314
state: Massachusetts
city: Watertown
country: United States
facility: Foamix Investigational Site #334
state: Massachusetts
city: Saint Joseph
country: United States
facility: Foamix Investigational Site #322
state: Missouri
city: Saint Louis
country: United States
facility: Foamix Investigational Site #372
state: Missouri
city: Lincoln
country: United States
facility: Foamix Investigational Site #391
state: Nebraska
city: Omaha
country: United States
facility: Foamix Investigational Site # 327
state: Nebraska
city: Las Vegas
country: United States
facility: Foamix Investigational Site #332
state: Nevada
city: Portsmouth
country: United States
facility: Foamix Investigational Site #344
state: New Hampshire
city: Berlin
country: United States
facility: Foamix Investigational Site #356
state: New Jersey
city: Verona
country: United States
facility: Foamix Investigational Site #337
state: New Jersey
city: Charlotte
country: United States
facility: Foamix Investigational Site #321
state: New York
city: New York
country: United States
facility: Foamix Investigational Site #355
state: New York
city: New York
country: United States
facility: Foamix Investigational Site #363
state: New York
city: Stony Brook
country: United States
facility: Foamix Investigational Site #307
state: New York
city: Charlotte
country: United States
facility: Foamix Investigational Site #350
state: North Carolina
city: Winston-Salem
country: United States
facility: Foamix Investigational Site #348
state: North Carolina
city: Fargo
country: United States
facility: Foamix Investigational Site #364
state: North Dakota
city: Bexley
country: United States
facility: Foamix Investigational Site #310
state: Ohio
city: Cincinnati
country: United States
facility: Foamix Investigational Site #386
state: Ohio
city: Cleveland
country: United States
facility: Foamix Investigational Site #353
state: Ohio
city: Dublin
country: United States
facility: Foamix Investigational Site #330
state: Ohio
city: Norman
country: United States
facility: Foamix Investigational Site #302
state: Oklahoma
city: Exton
country: United States
facility: Foamix Investigational Site #335
state: Pennsylvania
city: Hershey
country: United States
facility: Foamix Investigational Site #349
state: Pennsylvania
city: Jenkintown
country: United States
facility: Foamix Investigational Site #323
state: Pennsylvania
city: Charleston
country: United States
facility: Foamix Investigational Site #319
state: South Carolina
city: Mount Pleasant
country: United States
facility: Foamix Investigational Site #305
state: South Carolina
city: Knoxville
country: United States
facility: Foamix Investigational Site #308
state: Tennessee
city: Arlington
country: United States
facility: Foamix Research Site # 301
state: Texas
city: Arlington
country: United States
facility: Foamix Investigational Site #374
state: Texas
city: Austin
country: United States
facility: Foamix Investigational SIte #341
state: Texas
city: Austin
country: United States
facility: Foamix Investigational Site #351
state: Texas
city: Bryan
country: United States
facility: Foamix Investigational Site #402
state: Texas
city: Dallas
country: United States
facility: Foamix Investigational Site #358
state: Texas
city: Houston
country: United States
facility: Foamix Investigational Site #333
state: Texas
city: Houston
country: United States
facility: Foamix Investigational Site #352
state: Texas
city: Pflugerville
country: United States
facility: Foamix Investigational Site # 324
state: Texas
city: Lynchburg
country: United States
facility: Foamix Investigational SIte #379
state: Virginia
city: Norfolk
country: United States
facility: Foamix Investigational Site #343
state: Virginia
city: Seattle
country: United States
facility: Foamix Investigational Site #389
state: Washington
city: Tacoma
country: United States
facility: Foamix Investigational Site #359
state: Washington
Study officials:
References: