A Study to Evaluate the Efficacy and Safety of Topical Administration of FMX101 in the Treatment of Moderate-to-Severe Acne Vulgaris

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)

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 Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: Vehicle Foam; Drug: FMX101

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

• Study Type: Interventional
• Enrollment (Actual): 1488
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85023
      • Foamix Investigational Site #376
    • Tucson, Arizona, United States, 85712
      • Foamix Investigational Site #395
  • Arkansas
    • Bryant, Arkansas, United States, 72022
      • Foamix Investigational Site #315
    • Fort Smith, Arkansas, United States, 72916
      • Foamix Investigational Site #340
    • Little Rock, Arkansas, United States, 72212
      • Foamix Investigational SIte #377
  • California
    • Encino, California, United States, 91436
      • Foamix Investigational Site #366
    • Los Angeles, California, United States, 90036
      • Foamix Investigational Site #403
    • Murrieta, California, United States, 92562
      • Foamix Investigational Site #303
    • Northridge, California, United States, 91324
      • Foamix Investigational Site #369
    • Palm Springs, California, United States, 92262
      • Foamix Investigational Site #387
    • Pasadena, California, United States, 91105
      • Foamix Investigational Site #393
    • Poway, California, United States, 92064
      • Foamix Investigational Site #380
    • Sacramento, California, United States, 95819
      • Foamix Investigational Site # 328
    • San Diego, California, United States, 92123
      • Foamix Investigational Site #313
    • San Luis Obispo, California, United States, 93405
      • Foamix Investigational Site #336
    • Santa Ana, California, United States, 92705
      • Foamix Investigational Site #309
    • Santa Monica, California, United States, 90403
      • Foamix Investigational Site #325
    • Temecula, California, United States, 92592
      • Foamix Investigational Site #375
  • Florida
    • Aventura, Florida, United States, 33180
      • Foamix Investigational Site #381
    • Boca Raton, Florida, United States, 33431
      • Foamix Investigational SIte #371
    • Boca Raton, Florida, United States, 33486
      • Foamix Investigational Site #311
    • Brandon, Florida, United States, 33511
      • Foamix Investigational Site #398
    • Clearwater, Florida, United States, 33756
      • Foamix Investigational Site #329
    • Davie, Florida, United States, 33328
      • Foamix Investigational Site #378
    • DeLand, Florida, United States, 32720
      • Foamix Investigational Site #396
    • Doral, Florida, United States, 33126
      • Foamix Investigational Site #392
    • Fort Myers, Florida, United States, 33912
      • Foamix Investigational Site #318
    • Hialeah, Florida, United States, 33015
      • Foamix Investigational Site #401
    • Hialeah, Florida, United States, 33016
      • Foamix Investigational Site #400
    • Lake Worth, Florida, United States, 33467
      • Foamix Investigational Site #383
    • Miami, Florida, United States, 33126
      • Foamix Investigational Site #397
    • Miami, Florida, United States, 33155
      • Foamix Investigational Site #370
    • Miami Lakes, Florida, United States, 33016
      • Foamix Investigational Site #346
    • Miami Lakes, Florida, United States, 33104
      • Foamix Investigational Site #347
    • North Miami Beach, Florida, United States, 33162
      • Foamix Investigational Site #306
    • Ormond Beach, Florida, United States, 32174
      • Foamix Investigational Site #312
    • South Miami, Florida, United States, 33143
      • Foamix Investigational Site #362
    • Tamarac, Florida, United States, 33321
      • Foamix Investigational SIte #382
    • Tampa, Florida, United States, 33609
      • Foamix Investigational Site #399
    • Tampa, Florida, United States, 33624
      • Foamix Investigational Site #385
    • Tampa, Florida, United States, 33634
      • Foamix Investigational Site #394
    • West Palm Beach, Florida, United States, 33406
      • Foamix Investigational Site #360
  • Georgia
    • Columbus, Georgia, United States, 31904
      • Foamix Investigational Site #368
    • Sandy Springs, Georgia, United States, 30328
      • Foamix Investigational Site #336
  • Idaho
    • Nampa, Idaho, United States, 83651
      • Foamix Investigational Site #384
  • Illinois
    • Skokie, Illinois, United States, 60077
      • Foamix Investigational Site #345
    • West Dundee, Illinois, United States, 60118
      • Foamix Investigational Site #390
  • Indiana
    • Indianapolis, Indiana, United States, 46256
      • Foamix Investigational Site #365
    • New Albany, Indiana, United States, 47150
      • Foamix Investigational Site #316
    • Plainfield, Indiana, United States, 46168
      • Foamix Investigational Site #361
    • South Bend, Indiana, United States, 46617
      • Foamix Investigational Site #331
  • Kentucky
    • Louisville, Kentucky, United States, 40217
      • Foamix Investigational Site #320
    • Louisville, Kentucky, United States, 40241
      • Foamix Investigational SIte #367
  • Louisiana
    • New Orleans, Louisiana, United States, 70115
      • Foamix Investigational Site #317
    • New Orleans, Louisiana, United States, 70124
      • Foamix Investigational SIte #373
  • Maryland
    • Glenn Dale, Maryland, United States, 20769
      • Foamix Investigational Site #388
  • Massachusetts
    • Beverly, Massachusetts, United States, 01915
      • Foamix Investigational Site #304
    • Brighton, Massachusetts, United States, 02135
      • Foamix Investigational Site #314
    • Watertown, Massachusetts, United States, 02472
      • Foamix Investigational Site #334
  • Missouri
    • Saint Joseph, Missouri, United States, 64506
      • Foamix Investigational Site #322
    • Saint Louis, Missouri, United States, 63141
      • Foamix Investigational Site #372
  • Nebraska
    • Lincoln, Nebraska, United States, 68502
      • Foamix Investigational Site #391
    • Omaha, Nebraska, United States, 68144
      • Foamix Investigational Site # 327
  • Nevada
    • Las Vegas, Nevada, United States, 89728
      • Foamix Investigational Site #332
  • New Hampshire
    • Portsmouth, New Hampshire, United States, 03801
      • Foamix Investigational Site #344
  • New Jersey
    • Berlin, New Jersey, United States, 08009
      • Foamix Investigational Site #356
    • Verona, New Jersey, United States, 07044
      • Foamix Investigational Site #337
  • New York
    • Charlotte, New York, United States, 28277
      • Foamix Investigational Site #321
    • New York, New York, United States, 10016
      • Foamix Investigational Site #355
    • New York, New York, United States, 10155
      • Foamix Investigational Site #363
    • Stony Brook, New York, United States, 11790
      • Foamix Investigational Site #307
  • North Carolina
    • Charlotte, North Carolina, United States, 28277
      • Foamix Investigational Site #350
    • Winston-Salem, North Carolina, United States, 27104
      • Foamix Investigational Site #348
  • North Dakota
    • Fargo, North Dakota, United States, 58103
      • Foamix Investigational Site #364
  • Ohio
    • Bexley, Ohio, United States, 43209
      • Foamix Investigational Site #310
    • Cincinnati, Ohio, United States, 45212
      • Foamix Investigational Site #386
    • Cleveland, Ohio, United States, 44122
      • Foamix Investigational Site #353
    • Dublin, Ohio, United States, 43016
      • Foamix Investigational Site #330
  • Oklahoma
    • Norman, Oklahoma, United States, 73071
      • Foamix Investigational Site #302
  • Pennsylvania
    • Exton, Pennsylvania, United States, 19341
      • Foamix Investigational Site #335
    • Hershey, Pennsylvania, United States, 17033
      • Foamix Investigational Site #349
    • Jenkintown, Pennsylvania, United States, 19046
      • Foamix Investigational Site #323
  • South Carolina
    • Charleston, South Carolina, United States, 29407
      • Foamix Investigational Site #319
    • Mount Pleasant, South Carolina, United States, 29464
      • Foamix Investigational Site #305
  • Tennessee
    • Knoxville, Tennessee, United States, 37922
      • Foamix Investigational Site #308
  • Texas
    • Arlington, Texas, United States, 76011
      • Foamix Research Site # 301
    • Arlington, Texas, United States, 76014
      • Foamix Investigational Site #374
    • Austin, Texas, United States, 78704
      • Foamix Investigational SIte #341
    • Austin, Texas, United States, 78705
      • Foamix Investigational Site #351
    • Bryan, Texas, United States, 77802
      • Foamix Investigational Site #402
    • Dallas, Texas, United States, 75231
      • Foamix Investigational Site #358
    • Houston, Texas, United States, 77004
      • Foamix Investigational Site #333
    • Houston, Texas, United States, 77056
      • Foamix Investigational Site #352
    • Pflugerville, Texas, United States, 78660
      • Foamix Investigational Site # 324
  • Virginia
    • Lynchburg, Virginia, United States, 24501
      • Foamix Investigational SIte #379
    • Norfolk, Virginia, United States, 235070
      • Foamix Investigational Site #343
  • Washington
    • Seattle, Washington, United States, 98168
      • Foamix Investigational Site #389
    • Tacoma, Washington, United States, 98405
      • Foamix Investigational Site #359

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FMX101, 4% minocycline foam; FMX101, 4% minocycline foam applied topically once daily for 12 weeks	Drug: FMX101; FMX101, 4% minocycline foam
Placebo Comparator: Vehicle foam; Vehicle foam applied topically once daily for 12 weeks	Drug: Vehicle Foam; Vehicle Foam

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 12.	A decrease in the inflammatory lesion count from Baseline to Week 12.	12 weeks
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

Outcome Measure	Time Frame
The Absolute Change From Baseline in the Non-inflammatory Lesion Count at Week 12	12 weeks
The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 9	9 weeks
The Absolute Change From Baseline in the Inflammatory Lesion Count at the Interim Visit at Week 6	6 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
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

Collaborators and Investigators

• Sponsor: Vyne Therapeutics Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2017
• Primary Completion (Actual): September 4, 2018
• Study Completion (Actual): September 4, 2018

Study Registration Dates

• First Submitted: August 30, 2017
• First Submitted That Met QC Criteria: August 31, 2017
• First Posted (Actual): September 1, 2017

Study Record Updates

• Last Update Posted (Actual): January 18, 2022
• Last Update Submitted That Met QC Criteria: January 13, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Anti-Infective Agents; Anti-Bacterial Agents; Minocycline
• Other Study ID Numbers: FX2017-22

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No