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

January 13, 2022 updated by: Vyne Therapeutics Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1488

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 12.
Time Frame: 12 weeks
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
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
The Absolute Change From Baseline in the Non-inflammatory Lesion Count at Week 12
Time Frame: 12 weeks
12 weeks
The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 9
Time Frame: 9 weeks
9 weeks
The Absolute Change From Baseline in the Inflammatory Lesion Count at the Interim Visit at Week 6
Time Frame: 6 weeks
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
Time Frame: 6 weeks
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
Time Frame: 9 weeks
9 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vyne Therapeutics Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 17, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 4, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 4, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 30, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 1, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 18, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acne Vulgaris

Clinical Trials on Vehicle Foam

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings