A Study to Evaluate the Efficacy and Safety of Topical Administration of FMX101 in the Treatment of Moderate-to-Severe Acne Vulgaris
Primary Purpose
Acne Vulgaris
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
FMX101
Vehicle Foam
Sponsored by
About this trial
This is an interventional treatment trial for Acne Vulgaris
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
- 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.
Sites / Locations
- Foamix Investigational Site #376
- Foamix Investigational Site #395
- Foamix Investigational Site #315
- Foamix Investigational Site #340
- Foamix Investigational SIte #377
- Foamix Investigational Site #366
- Foamix Investigational Site #403
- Foamix Investigational Site #303
- Foamix Investigational Site #369
- Foamix Investigational Site #387
- Foamix Investigational Site #393
- Foamix Investigational Site #380
- Foamix Investigational Site # 328
- Foamix Investigational Site #313
- Foamix Investigational Site #336
- Foamix Investigational Site #309
- Foamix Investigational Site #325
- Foamix Investigational Site #375
- Foamix Investigational Site #381
- Foamix Investigational SIte #371
- Foamix Investigational Site #311
- Foamix Investigational Site #398
- Foamix Investigational Site #329
- Foamix Investigational Site #378
- Foamix Investigational Site #396
- Foamix Investigational Site #392
- Foamix Investigational Site #318
- Foamix Investigational Site #401
- Foamix Investigational Site #400
- Foamix Investigational Site #383
- Foamix Investigational Site #346
- Foamix Investigational Site #347
- Foamix Investigational Site #397
- Foamix Investigational Site #370
- Foamix Investigational Site #306
- Foamix Investigational Site #312
- Foamix Investigational Site #362
- Foamix Investigational SIte #382
- Foamix Investigational Site #399
- Foamix Investigational Site #385
- Foamix Investigational Site #394
- Foamix Investigational Site #360
- Foamix Investigational Site #368
- Foamix Investigational Site #336
- Foamix Investigational Site #384
- Foamix Investigational Site #345
- Foamix Investigational Site #390
- Foamix Investigational Site #365
- Foamix Investigational Site #316
- Foamix Investigational Site #361
- Foamix Investigational Site #331
- Foamix Investigational Site #320
- Foamix Investigational SIte #367
- Foamix Investigational Site #317
- Foamix Investigational SIte #373
- Foamix Investigational Site #388
- Foamix Investigational Site #304
- Foamix Investigational Site #314
- Foamix Investigational Site #334
- Foamix Investigational Site #322
- Foamix Investigational Site #372
- Foamix Investigational Site #391
- Foamix Investigational Site # 327
- Foamix Investigational Site #332
- Foamix Investigational Site #344
- Foamix Investigational Site #356
- Foamix Investigational Site #337
- Foamix Investigational Site #321
- Foamix Investigational Site #355
- Foamix Investigational Site #363
- Foamix Investigational Site #307
- Foamix Investigational Site #350
- Foamix Investigational Site #348
- Foamix Investigational Site #364
- Foamix Investigational Site #310
- Foamix Investigational Site #386
- Foamix Investigational Site #353
- Foamix Investigational Site #330
- Foamix Investigational Site #302
- Foamix Investigational Site #335
- Foamix Investigational Site #349
- Foamix Investigational Site #323
- Foamix Investigational Site #319
- Foamix Investigational Site #305
- Foamix Investigational Site #308
- Foamix Research Site # 301
- Foamix Investigational Site #374
- Foamix Investigational SIte #341
- Foamix Investigational Site #351
- Foamix Investigational Site #402
- Foamix Investigational Site #358
- Foamix Investigational Site #333
- Foamix Investigational Site #352
- Foamix Investigational Site # 324
- Foamix Investigational SIte #379
- Foamix Investigational Site #343
- Foamix Investigational Site #389
- Foamix Investigational Site #359
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
FMX101, 4% minocycline foam
Vehicle foam
Arm Description
FMX101, 4% minocycline foam applied topically once daily for 12 weeks
Vehicle foam applied topically once daily for 12 weeks
Outcomes
Primary Outcome Measures
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.
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
Secondary Outcome Measures
The Absolute Change From Baseline in the Non-inflammatory Lesion Count at Week 12
The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 9
The Absolute Change From Baseline in the Inflammatory Lesion Count at the Interim Visit at Week 6
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
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
Full Information
NCT ID
NCT03271021
First Posted
August 30, 2017
Last Updated
January 13, 2022
Sponsor
Vyne Therapeutics Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03271021
Brief Title
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
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
July 17, 2017 (Actual)
Primary Completion Date
September 4, 2018 (Actual)
Study Completion Date
September 4, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vyne Therapeutics Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1488 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FMX101, 4% minocycline foam
Arm Type
Experimental
Arm Description
FMX101, 4% minocycline foam applied topically once daily for 12 weeks
Arm Title
Vehicle foam
Arm Type
Placebo Comparator
Arm Description
Vehicle foam applied topically once daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
FMX101
Intervention Description
FMX101, 4% minocycline foam
Intervention Type
Drug
Intervention Name(s)
Vehicle Foam
Intervention Description
Vehicle Foam
Primary Outcome Measure Information:
Title
The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 12.
Description
A decrease in the inflammatory lesion count from Baseline to Week 12.
Time Frame
12 weeks
Title
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
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
The Absolute Change From Baseline in the Non-inflammatory Lesion Count at Week 12
Time Frame
12 weeks
Title
The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 9
Time Frame
9 weeks
Title
The Absolute Change From Baseline in the Inflammatory Lesion Count at the Interim Visit at Week 6
Time Frame
6 weeks
Title
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
Time Frame
6 weeks
Title
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
Time Frame
9 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Facility Information:
Facility Name
Foamix Investigational Site #376
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Facility Name
Foamix Investigational Site #395
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Foamix Investigational Site #315
City
Bryant
State/Province
Arkansas
ZIP/Postal Code
72022
Country
United States
Facility Name
Foamix Investigational Site #340
City
Fort Smith
State/Province
Arkansas
ZIP/Postal Code
72916
Country
United States
Facility Name
Foamix Investigational SIte #377
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72212
Country
United States
Facility Name
Foamix Investigational Site #366
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
Foamix Investigational Site #403
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
Foamix Investigational Site #303
City
Murrieta
State/Province
California
ZIP/Postal Code
92562
Country
United States
Facility Name
Foamix Investigational Site #369
City
Northridge
State/Province
California
ZIP/Postal Code
91324
Country
United States
Facility Name
Foamix Investigational Site #387
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Facility Name
Foamix Investigational Site #393
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Foamix Investigational Site #380
City
Poway
State/Province
California
ZIP/Postal Code
92064
Country
United States
Facility Name
Foamix Investigational Site # 328
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
Foamix Investigational Site #313
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Foamix Investigational Site #336
City
San Luis Obispo
State/Province
California
ZIP/Postal Code
93405
Country
United States
Facility Name
Foamix Investigational Site #309
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Foamix Investigational Site #325
City
Santa Monica
State/Province
California
ZIP/Postal Code
90403
Country
United States
Facility Name
Foamix Investigational Site #375
City
Temecula
State/Province
California
ZIP/Postal Code
92592
Country
United States
Facility Name
Foamix Investigational Site #381
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Foamix Investigational SIte #371
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33431
Country
United States
Facility Name
Foamix Investigational Site #311
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Foamix Investigational Site #398
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Foamix Investigational Site #329
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Foamix Investigational Site #378
City
Davie
State/Province
Florida
ZIP/Postal Code
33328
Country
United States
Facility Name
Foamix Investigational Site #396
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Foamix Investigational Site #392
City
Doral
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Foamix Investigational Site #318
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Foamix Investigational Site #401
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33015
Country
United States
Facility Name
Foamix Investigational Site #400
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Foamix Investigational Site #383
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33467
Country
United States
Facility Name
Foamix Investigational Site #346
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Foamix Investigational Site #347
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33104
Country
United States
Facility Name
Foamix Investigational Site #397
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Foamix Investigational Site #370
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Foamix Investigational Site #306
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33162
Country
United States
Facility Name
Foamix Investigational Site #312
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Foamix Investigational Site #362
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Foamix Investigational SIte #382
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Facility Name
Foamix Investigational Site #399
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Foamix Investigational Site #385
City
Tampa
State/Province
Florida
ZIP/Postal Code
33624
Country
United States
Facility Name
Foamix Investigational Site #394
City
Tampa
State/Province
Florida
ZIP/Postal Code
33634
Country
United States
Facility Name
Foamix Investigational Site #360
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33406
Country
United States
Facility Name
Foamix Investigational Site #368
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Foamix Investigational Site #336
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Foamix Investigational Site #384
City
Nampa
State/Province
Idaho
ZIP/Postal Code
83651
Country
United States
Facility Name
Foamix Investigational Site #345
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Facility Name
Foamix Investigational Site #390
City
West Dundee
State/Province
Illinois
ZIP/Postal Code
60118
Country
United States
Facility Name
Foamix Investigational Site #365
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
Foamix Investigational Site #316
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
Foamix Investigational Site #361
City
Plainfield
State/Province
Indiana
ZIP/Postal Code
46168
Country
United States
Facility Name
Foamix Investigational Site #331
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617
Country
United States
Facility Name
Foamix Investigational Site #320
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Facility Name
Foamix Investigational SIte #367
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States
Facility Name
Foamix Investigational Site #317
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Foamix Investigational SIte #373
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70124
Country
United States
Facility Name
Foamix Investigational Site #388
City
Glenn Dale
State/Province
Maryland
ZIP/Postal Code
20769
Country
United States
Facility Name
Foamix Investigational Site #304
City
Beverly
State/Province
Massachusetts
ZIP/Postal Code
01915
Country
United States
Facility Name
Foamix Investigational Site #314
City
Brighton
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
Foamix Investigational Site #334
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
Facility Name
Foamix Investigational Site #322
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64506
Country
United States
Facility Name
Foamix Investigational Site #372
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Foamix Investigational Site #391
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68502
Country
United States
Facility Name
Foamix Investigational Site # 327
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
Foamix Investigational Site #332
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89728
Country
United States
Facility Name
Foamix Investigational Site #344
City
Portsmouth
State/Province
New Hampshire
ZIP/Postal Code
03801
Country
United States
Facility Name
Foamix Investigational Site #356
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Foamix Investigational Site #337
City
Verona
State/Province
New Jersey
ZIP/Postal Code
07044
Country
United States
Facility Name
Foamix Investigational Site #321
City
Charlotte
State/Province
New York
ZIP/Postal Code
28277
Country
United States
Facility Name
Foamix Investigational Site #355
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Foamix Investigational Site #363
City
New York
State/Province
New York
ZIP/Postal Code
10155
Country
United States
Facility Name
Foamix Investigational Site #307
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11790
Country
United States
Facility Name
Foamix Investigational Site #350
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Facility Name
Foamix Investigational Site #348
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27104
Country
United States
Facility Name
Foamix Investigational Site #364
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Facility Name
Foamix Investigational Site #310
City
Bexley
State/Province
Ohio
ZIP/Postal Code
43209
Country
United States
Facility Name
Foamix Investigational Site #386
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
Foamix Investigational Site #353
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Foamix Investigational Site #330
City
Dublin
State/Province
Ohio
ZIP/Postal Code
43016
Country
United States
Facility Name
Foamix Investigational Site #302
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73071
Country
United States
Facility Name
Foamix Investigational Site #335
City
Exton
State/Province
Pennsylvania
ZIP/Postal Code
19341
Country
United States
Facility Name
Foamix Investigational Site #349
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Foamix Investigational Site #323
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
Facility Name
Foamix Investigational Site #319
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
Foamix Investigational Site #305
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Foamix Investigational Site #308
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37922
Country
United States
Facility Name
Foamix Research Site # 301
City
Arlington
State/Province
Texas
ZIP/Postal Code
76011
Country
United States
Facility Name
Foamix Investigational Site #374
City
Arlington
State/Province
Texas
ZIP/Postal Code
76014
Country
United States
Facility Name
Foamix Investigational SIte #341
City
Austin
State/Province
Texas
ZIP/Postal Code
78704
Country
United States
Facility Name
Foamix Investigational Site #351
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Foamix Investigational Site #402
City
Bryan
State/Province
Texas
ZIP/Postal Code
77802
Country
United States
Facility Name
Foamix Investigational Site #358
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Foamix Investigational Site #333
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Foamix Investigational Site #352
City
Houston
State/Province
Texas
ZIP/Postal Code
77056
Country
United States
Facility Name
Foamix Investigational Site # 324
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
Facility Name
Foamix Investigational SIte #379
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States
Facility Name
Foamix Investigational Site #343
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
235070
Country
United States
Facility Name
Foamix Investigational Site #389
City
Seattle
State/Province
Washington
ZIP/Postal Code
98168
Country
United States
Facility Name
Foamix Investigational Site #359
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Efficacy and Safety of Topical Administration of FMX101 in the Treatment of Moderate-to-Severe Acne Vulgaris
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