Acne VulgarisPhase 3NCT03271021

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

A Phase 3 study testing FMX101 in people with Acne Vulgaris, run by Vyne Therapeutics Inc. at 98 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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) Read more about this study

Who is it for?: Ages 9 years and older
Conditions the study is for: Acne Vulgaris
What is being tested?: FMX101
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,488 participants
Where: 98 sitesUnited States
Study dates: 17 Jul 2017to 4 Sep 2018
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 9 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

98 sites in 1 country.

City, postcode or hospital

98 sites in 1 country

United States98 sites

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

Other trials in United States

About this study

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)

Read the 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

Conditions: Acne Vulgaris
Being tested: FMX101, Vehicle Foam
Medical subject headings: Acne Vulgaris

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FMX101Drug
FMX101, 4% minocycline foam
Vehicle FoamDrug
Vehicle Foam

Study groups in NCT03271021
Study group	Role	What they receive
FMX101, 4% minocycline foam	Experimental	FMX101, 4% minocycline foam applied topically once daily for 12 weeks Receives: Drug: FMX101
Vehicle foam	Placebo comparator	Vehicle foam applied topically once daily for 12 weeks Receives: Drug: Vehicle Foam

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
Measured: 12 weeks

Secondary outcomes (5)

The Absolute Change From Baseline in the Non-inflammatory Lesion Count at Week 12
Measured: 12 weeks
The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 9
Measured: 9 weeks
The Absolute Change From Baseline in the Inflammatory Lesion Count at the Interim Visit at Week 6
Measured: 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
Measured: 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
Measured: 9 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Jul 20174 Sep 2018

First posted1 Sep 2017
Study start17 Jul 2017
Primary completion4 Sep 2018
Study completion4 Sep 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Acne VulgarisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,488 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03271021
Sponsor's protocol ID: FX2017-22
Status last verified: Jan 2022
First submitted: 30 Aug 2017
Last updated: 18 Jan 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT03271021
Acronym / sponsor ID: FX2017-22
Conditions: Acne Vulgaris
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,488 participants (actual)
Lead sponsor: Vyne Therapeutics Inc.Industry (pharma, biotech, devices)
Study start: 17 Jul 2017 (actual)
Primary completion: 4 Sep 2018 (actual)
Study completion: 4 Sep 2018 (actual)
First posted: 1 Sep 2017 (actual)
Results: Posted 21 Feb 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

FMX101 4% minocycline foam
Vehicle foam

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
FMX101, 4% minocycline foam	Experimental	Drug: FMX101FMX101, 4% minocycline foam applied topically once daily for 12 weeks
Vehicle foam	Placebo comparator	Drug: Vehicle FoamVehicle foam applied topically once daily for 12 weeks

Who may qualify

Ages: 9 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (6 listed)

Has facial acne vulgaris with:
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.

Key exclusion criteria (2 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FMX101FMX101, 4% minocycline foam	Drug	FMX101, 4% minocycline foam
Vehicle FoamVehicle Foam	Drug	Vehicle foam

Primary outcome

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.
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

5 secondary outcomes

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

Results and safety

Results posted to the registry on 21 Feb 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
FMX101, 4% Minocycline Foam	738	649
Vehicle Foam	750	644

Primary outcome: The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 12.

Time frame: 12 weeks. Least squares mean (95% Confidence Interval). Unit: Lesion Count

Measure	FMX101, 4% Minocycline Foam n = 738	Vehicle Foam n = 750
Value	16.39 (15.53 to 17.25)	12.74 (11.88 to 13.61)

Primary outcome: 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. Number. Unit: participants

Measure	FMX101, 4% Minocycline Foam n = 738	Vehicle Foam n = 750
Value	199	133

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 16 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
FMX101, 4% Minocycline Foam	1 of 737 (0.1%)	0 of 737 (0%)	0 of 737
Vehicle Foam	4 of 747 (0.5%)	0 of 747 (0%)	0 of 747

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

Related trials for Acne Vulgaris

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

98 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing FMX101 in people with Acne Vulgaris, run by Vyne Therapeutics Inc. at 98 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 98 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 12. (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03271021.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2022.