Acne VulgarisPhase 3NCT02815267

A Study to Compare the Efficacy and Safety of Topical Administration of FMX-101 for Treatment of Moderate-to-Severe Acne

A Phase 3 study testing FMX-101, 4% minocycline foam in people with Acne Vulgaris, run by Vyne Therapeutics Inc. at 31 sites in 2 countries.

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

This is a Phase 3 study to evaluate the efficacy, safety and long-term safety of the topical administration of FMX-101, 4% minocycline foam for the treatment of moderate-to-severe acne vulgaris. 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?: FMX-101, 4% minocycline foam
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 466 participants
Where: 31 sitesin 2 countries
Study dates: May 2016to 13 Oct 2017
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 noninflammatory lesions (open and closed comedones);
no more than 2 nodules on the face; and
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
Severe systemic disease, which might interfere with the conduct of the study or the interpretation of the results.
Abnormal baseline laboratory values that are considered clinically significant
Allergy to tetracycline-class antibiotics or to any ingredient in the study drug
Pseudomembranous colitis or antibiotic-associated colitis

Trial locations and contacts

31 sites in 2 countries.

Country

City, postcode or hospital

31 sites in 2 countries

United States30 sites

Study site
Bay City, Michigan, 48706
Study site
Birmingham, Alabama, 35205
Study site
Boynton Beach, Florida, 33437
Study site
Bridgeport, West Virginia, 26330
Study site
Columbus, Ohio, 43213
Study site
Dallas, Texas, 75234
Study site
Evansville, Indiana, 47713
Study site
Fremont, California, 94538
Study site
Fullerton, California, 92835
Study site
Gresham, Oregon, 97030
Study site
High Point, North Carolina, 27262
Study site
Johnston, Rhode Island, 02919
Study site
Las Vegas, Nevada, 89117
Study site
Metairie, Louisiana, 70006
Study site
Miami, Florida, 33015
Study site
Miami, Florida, 33174
Study site
Miramar, Florida, 33027
Study site
Murfreesboro, Tennessee, 37130
Study site
New York, New York, 10012
Study site
New York, New York, 10075
Study site
Oakbrook Terrace, Illinois, 60181
Study site
Omaha, Nebraska, 68114
Study site
Plano, Texas, 75024
Study site
Rockville, Maryland, 20850
Study site
San Antonio, Texas, 78229
Study site
Sanford, Florida, 32771
Study site
Savannah, Georgia, 31406
Study site
Shelton, Connecticut, 06484
Study site
Washington D.C., District of Columbia, 20037
Study site
West Jordan, Utah, 84088

Other trials in United States

Dominican Republic1 site

Study site
San Cristobal

Other trials in Dominican Republic

About this study

Official title: A Randomized, Double-Blind Study to Compare the Efficacy, Safety and Long-Term Safety of Topical Administration of FMX-101 for 1 Year in the Treatment of Moderate-to-Severe Acne Vulgaris, Study FX2014-04

This is a Phase 3 study to evaluate the efficacy, safety and long-term safety of the topical administration of FMX-101, 4% minocycline foam for the treatment of moderate-to-severe acne vulgaris.

Conditions: Acne Vulgaris
Being tested: FMX-101, 4% minocycline foam, Vehicle Foam
Keywords: acne
Medical subject headings: Acne Vulgaris

What participants receive

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

FMX-101, 4% minocycline foamDrug
FMX-101, 4% minocycline foam applied topically once daily for 12 weeks
Vehicle FoamDrug
Vehicle foam applied topically once daily for 12 weeks

Study groups in NCT02815267
Study group	Role	What they receive
FMX-101, 4% minocycline foam	Experimental	Subjects will apply the assigned FMX-101, 4% minocycline foam topically once daily for 12 weeks as directed Receives: Drug: FMX-101, 4% minocycline foam
Vehicle foam	Placebo comparator	Subjects will apply the assigned vehicle foam topically once daily for 12 weeks as directed Receives: Drug: Vehicle Foam

What is being measured

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

Absolute Change From Baseline in the Inflammatory Lesion Count at Week 12
To evaluate the efficacy in the treatment of acne compared to vehicle of topical FMX101 4% administered daily for 12 weeks. Changes from Baseline are calculated as Baseline value minus post-Baseline value, so that decreases appear as positive values. Inflammatory lesion count included: papules, pustules, and nodules.
Measured: Baseline and Week 12
Percentage of Participants Achieving Investigator's Global Assessments (IGA) Treatment Success at Week 12
The IGA scale for acne vulgaris, was used by the investigators to assess the severity of a participant's acne vulgaris. The scale ranges from 0 (Clear): normal, clear skin with no evidence of acne vulgaris to 5 (Very Severe): highly inflammatory lesions predominate, variable number of comedones, many papules/pustules and many nodulocystic lesions. Higher scores indicated severe outcome. Treatment success was defined as an IGA score of 0 (score of clear) or 1 (almost clear), and at least a 2-grade improvement (decrease) from Baseline.
Measured: Baseline and Week 12

Secondary outcomes (4)

Percent Change From Baseline in the Non-inflammatory Lesion Count at Week 12
To evaluate the efficacy in the treatment of acne compared to vehicle of topical FMX101 4% administered daily for 12 weeks. Percent change from Baseline is calculated as the Baseline value minus the post-Baseline value divided by the baseline value, expressed as a percentage. Non-inflammatory lesions included: open comedones (blackhead) and closed comedones (whitehead).
Measured: Baseline and Week 12
Absolute Change From Baseline in the Inflammatory Lesion Count at Week 6 and Week 9
To evaluate the efficacy in the treatment of acne compared to vehicle of topical FMX101 4% administered daily for 12 weeks. Changes from Baseline are calculated as Baseline value minus post-Baseline value, so that decreases appear as positive values. Inflammatory lesion count included: papules, pustules, and nodules.
Measured: Baseline, at Week 6 and at Week 9
Percentage of Participants Achieving IGA Treatment Success at Week 6 and Week 9
The IGA scale for acne vulgaris, was used by the investigators to assess the severity of a participant's acne vulgaris. The scale ranges from 0 (Clear): normal, clear skin with no evidence of acne vulgaris to 5 (Very Severe): highly inflammatory lesions predominate, variable number of comedones, many papules/pustules and many nodulocystic lesions. Higher scores indicated severe outcome. Treatment success was defined as an IGA score of 0 (score of clear) or 1 (almost clear), and at least a 2-grade improvement (decrease) from Baseline.
Measured: Baseline, at Week 6 and at Week 9
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and and Treatment-emergent Serious Adverse Events (TESAEs)
To evaluate the safety compared to vehicle of topical FMX101 4% administered daily for 12 weeks and to evaluate the long-term safety of topical FMX101 4% administered daily for up to an additional 40 weeks. TEAEs of the double-blind phase were defined as AEs starting on or after date of first application of investigational product (IP), but before the date of the first application of the open-label phase, and AEs starting on or after the first application of the open-label phase are considered as TEAEs of the open-label phase.
Measured: Double blind: Screening Day until Week 12; Open-label: Week 16 until Week 52

Timeline

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

May 201613 Oct 2017

First posted28 Jun 2016 (estimated)
Study startMay 2016
Primary completion13 Oct 2017
Study completion13 Oct 2017

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: Double blind
Who is masked: Participant, Investigator
Enrolment: 466 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02815267
Sponsor's protocol ID: FX2014-04
Status last verified: Jan 2022
First submitted: 24 May 2016
Last updated: 18 Jan 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: 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 Study to Compare the Efficacy, Safety and Long-Term Safety of Topical Administration of FMX-101 for 1 Year in the Treatment of Moderate-to-Severe Acne Vulgaris, Study FX2014-04
ClinicalTrials.gov ID: NCT02815267
Acronym / sponsor ID: FX2014-04
Conditions: Acne Vulgaris
Keywords: acne
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 466 participants (actual)
Lead sponsor: Vyne Therapeutics Inc.Industry (pharma, biotech, devices)
Study start: May 2016 (actual)
Primary completion: 13 Oct 2017 (actual)
Study completion: 13 Oct 2017 (actual)
First posted: 28 Jun 2016 (estimated)
Results: Posted 22 Sep 2020

Clinical summary

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

This is a Phase 3 study to evaluate the efficacy, safety and long-term safety of the topical administration of FMX-101, 4% minocycline foam for the treatment of moderate-to-severe acne vulgaris.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
FMX-101, 4% minocycline foam	Experimental	Drug: FMX-101, 4% minocycline foamSubjects will apply the assigned FMX-101, 4% minocycline foam topically once daily for 12 weeks as directed
Vehicle foam	Placebo comparator	Drug: Vehicle FoamSubjects will apply the assigned vehicle foam topically once daily for 12 weeks as directed

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 (6 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
Severe systemic disease, which might interfere with the conduct of the study or the interpretation of the results.
Abnormal baseline laboratory values that are considered clinically significant
Allergy to tetracycline-class antibiotics or to any ingredient in the study drug

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
FMX-101, 4% minocycline foamFMX-101, 4% minocycline foam applied topically once daily for 12 weeks	Drug	FMX-101, 4% minocycline foam
Vehicle FoamVehicle foam applied topically once daily for 12 weeks	Drug	Vehicle foam

Primary outcome

Absolute Change From Baseline in the Inflammatory Lesion Count at Week 12
Time frame: Baseline and Week 12
To evaluate the efficacy in the treatment of acne compared to vehicle of topical FMX101 4% administered daily for 12 weeks. Changes from Baseline are calculated as Baseline value minus post-Baseline value, so that decreases appear as positive values. Inflammatory lesion count included: papules, pustules, and nodules.
Percentage of Participants Achieving Investigator's Global Assessments (IGA) Treatment Success at Week 12
Time frame: Baseline and Week 12
The IGA scale for acne vulgaris, was used by the investigators to assess the severity of a participant's acne vulgaris. The scale ranges from 0 (Clear): normal, clear skin with no evidence of acne vulgaris to 5 (Very Severe): highly inflammatory lesions predominate, variable number of comedones, many papules/pustules and many nodulocystic lesions. Higher scores indicated severe outcome. Treatment success was defined as an IGA score of 0 (score of clear) or 1 (almost clear), and at least a 2-grade improvement (decrease) from Baseline.

4 secondary outcomes

Percent Change From Baseline in the Non-inflammatory Lesion Count at Week 12
Time frame: Baseline and Week 12
Absolute Change From Baseline in the Inflammatory Lesion Count at Week 6 and Week 9
Time frame: Baseline, at Week 6 and at Week 9
Percentage of Participants Achieving IGA Treatment Success at Week 6 and Week 9
Time frame: Baseline, at Week 6 and at Week 9
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and and Treatment-emergent Serious Adverse Events (TESAEs)
Time frame: Double blind: Screening Day until Week 12; Open-label: Week 16 until Week 52

Results and safety

Results posted to the registry on 22 Sep 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
FMX-101, 4% Minocycline Foam	307	274
Vehicle Foam	159	128

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

Time frame: Baseline and Week 12. Least squares mean (Standard Error). Unit: Lesion counts

Measure	FMX-101, 4% Minocycline Foam n = 307	Vehicle Foam n = 159
Value	13.95 (0.65)	11.15 (0.90)

FMX-101, 4% Minocycline Foam vs Vehicle Foam: Mean Difference (Final Values): 2.80 (95% CI 0.72 to 4.88), p = 0.0083, ANCOVA

Population analysed: Intent-to-Treat (ITT) population: included all randomized participants.

Primary outcome: Percentage of Participants Achieving Investigator's Global Assessments (IGA) Treatment Success at Week 12

Time frame: Baseline and Week 12. Number. Unit: Percentage of participants

Measure	FMX-101, 4% Minocycline Foam n = 307	Vehicle Foam n = 159
Value	8.09	4.77

FMX-101, 4% Minocycline Foam vs Vehicle Foam: Risk Difference (RD): 3.33 (95% CI -1.54 to 8.19), p = 0.1805, Cochran-Mantel-Haenszel

Population analysed: An ITT population: included all randomized participants.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Double blind: Screening Day until Week 12; Open-label: Week 16 until Week 52. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Double-blind-FMX-101, 4% Minocycline Foam	1 of 307 (0.3%)	13 of 307 (4.2%)	0 of 307
Double-blind-Vehicle Foam	0 of 159 (0%)	11 of 159 (6.9%)	0 of 159
Open-label-FMX-101, 4% Minocycline Foam	1 of 284 (0.4%)	19 of 284 (6.7%)	0 of 284

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.
Individual participant dataSharing planned: No

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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.

31 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing FMX-101, 4% minocycline foam in people with Acne Vulgaris, run by Vyne Therapeutics Inc. at 31 sites in 2 countries.

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 6 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 31 sites in United States, Dominican Republic. 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 22 Sep 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?

Absolute Change From Baseline in the Inflammatory Lesion Count at Week 12 (time frame: Baseline and Week 12). 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 NCT02815267.

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.