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Papulopustular RosaceaPhase 3NCT03276936

A Study to Evaluate the Long-Term Safety of Topical Administration of FMX103 in the Treatment of Moderate to Severe Papulopustular Rosacea

A Phase 3 study testing FMX103 1.5% in people with Papulopustular Rosacea, run by Vyne Therapeutics Inc. at 79 sites in United States.

Completed

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

Official record
Search all trials

Trial summary

The primary objective is to show that open-label extended treatment with FMX103 1.5%, for up to an additional 40 weeks, is safe and well tolerated. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Papulopustular Rosacea
What is being tested?
FMX103 1.5%
Could I receive a placebo?
No, everyone receives an active treatment
How many people
504 participants
Where
79 sitesUnited States
Study dates
5 Sep 2017to 15 Jan 2019
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have completed 12 weeks of treatment in either Study FX2016-11 or Study FX2016-12.
  • Have not had a worsening of disease, determined by the Investigator's Global Assessment (IGA), at Visit 5/Week 12 (Final Visit) relative to the Day 0/Baseline assessment in Study FX2016-11 or Study FX2016-12.

Who cannot join

  • Have a new systemic disease or condition, including an ongoing AE that might interfere with the conduct of the study or the interpretation of results.
  • Have developed a condition that would have been exclusionary for Study FX2016-11 or Study FX2016-12, including pseudomembranous colitis, antibiotic associated colitis, hepatitis, liver damage, renal impairment, drug addiction, or alcohol abuse.

Trial locations and contacts

79 sites in 1 country.

79 sites in 1 country

United States79 sites

  • Foamix Investigational Site # 118

    Alpharetta, Georgia, 30022

  • Foamix Investigational Site # 137

    Ann Arbor, Michigan, 48103

  • Foamix Investigational Site # 219

    Arlington, Texas, 76011

  • Foamix Investigational Site # 211

    Arlington Heights, Illinois, 60005

  • Foamix Investigational Site # 132

    Austin, Texas, 78746

  • Foamix Investigational Site # 117

    Austin, Texas, 78759

  • Foamix Investigational Site # 242

    Bay City, Michigan, 48706

  • Foamix Investigational Site # 110

    Beverly, Massachusetts, 01915

  • Foamix Investigational Site # 101

    Bexley, Ohio, 43209

  • Foamix Investigational Site # 223

    Boca Raton, Florida, 33486

  • Foamix Investigational Site # 215

    Boynton Beach, Florida, 33437

  • Foamix Investigational Site # 107

    Brighton, Massachusetts, 02135

  • Foamix Investigational Site # 231

    Charleston, South Carolina, 29407

  • Foamix Investigational Site # 119

    Charlotte, North Carolina, 28277

  • Foamix Investigational Site # 109

    Clearwater, Florida, 33757

  • Foamix Investigational Site # 227

    Denver, Colorado, 80209

  • Foamix Investigational Site # 210

    Detroit, Michigan, 48202

  • Foamix Investigational Site # 128

    Dublin, Ohio, 43016

  • Foamix Investigational Site # 224

    Exton, Pennsylvania, 19341

  • Foamix Investigational Site # 103

    Fort Gratiot, Michigan, 48059

  • Foamix Investigational Site # 240

    Fort Myers, Florida, 33912

  • Foamix Investigational Site # 127

    Fremont, California, 94538

  • Foamix Investigational Site # 232

    Fridley, Minnesota, 55432

  • Foamix Investigational Site # 207

    Glendale, Arizona, 85308

  • Foamix Investigational Site # 106

    Greenville, South Carolina, 29607

  • Foamix Investigational Site # 112

    Hialeah, Florida, 33016

  • Foamix Investigational Site # 238

    High Point, North Carolina, 27262

  • Foamix Investigational Site # 202

    Hot Springs, Arkansas, 71913

  • Foamix Investigational Site # 201

    Houston, Texas, 77004

  • Foamix Investigational Site # 141

    Jenkintown, Pennsylvania, 19046

  • Foamix Investigational Site # 105

    Johnston, Rhode Island, 02919

  • Foamix Investigational Site # 228

    Knoxville, Tennessee, 37922

  • Foamix Investigational Site # 221

    Las Vegas, Nevada, 89128

  • Foamix Investigational Site # 226

    Los Angeles, California, 90045

  • Foamix Investigational Site # 235

    Louisville, Kentucky, 40217

  • Foamix Investigational Site # 237

    Louisville, Kentucky, 40241

  • Foamix Investigational Site # 216

    Lynchburg, Virginia, 24501

  • Foamix Investigational Site # 102

    Metairie, Louisiana, 70006

  • Foamix Investigational Site # 214

    Miami, Florida, 33126

  • Foamix Investigational Site # 230

    Mt. Pleasant, South Carolina, 29464

  • Foamix Investigational Site # 220

    Murrieta, California, 92562

  • Foamix Investigational Site # 138

    New Albany, Indiana, 47150

  • Foamix Investigational Site # 115

    New Orleans, Louisiana, 70115

  • Foamix Investigational Site # 136

    New York, New York, 10075

  • Foamix Investigational Site # 225

    Newburgh, Indiana, 47630

  • Foamix Investigational Site # 204

    Newnan, Georgia, 78660

  • Foamix Investigational Site # 236

    Norman, Oklahoma, 73071

  • Foamix Investigational Site # 241

    North Miami Beach, Florida, 33162

  • Foamix Investigational Site # 131

    Oceanside, California, 92056

  • Foamix Investigational Site # 133

    Omaha, Nebraska, 68144

  • Foamix Investigational Site # 104

    Ormond Beach, Florida, 32174

  • Foamix Investigational Site # 206

    Pflugerville, Texas, 78660

  • Foamix Investigational Site # 212

    Raleigh, North Carolina, 27612

  • Foamix Investigational Site # 222

    Rogers, Arkansas, 72758

  • Foamix Investigational Site # 134

    Sacramento, California, 95819

  • Foamix Investigational Site # 130

    Saint Joseph, Missouri, 64506

  • Foamix Investigational Site # 126

    Salt Lake City, Utah, 84117

  • Foamix Investigational Site # 108

    San Antonio, Texas, 78213

  • Foamix Investigational Site # 208

    San Antonio, Texas, 78229

  • Foamix Investigational Site # 213

    San Antonio, Texas, 78229

  • Foamix Investigational Site # 114

    San Diego, California, 92123

  • Foamix Investigational Site # 116

    San Luis Obispo, California, 93405

  • Foamix Investigational Site # 233

    Sandy Springs, Georgia, 30328

  • Foamix Investigational Site # 121

    Sanford, Florida, 32771

  • Foamix Investigational Site # 135

    Santa Ana, California, 92705

  • Foamix Investigational Site # 123

    Santa Monica, California, 90403

  • Foamix Investigational Site # 203

    Seattle, Washington, 98104

  • Foamix Investigational Site # 139

    Snellville, Georgia, 30078

  • Foamix Investigational Site # 218

    South Bend, Indiana, 46617

  • Foamix Investigational Site # 111

    Stony Brook, New York, 11790

  • Foamix Investigational Site # 125

    Tampa, Florida, 33609

  • Foamix Investigational Site # 239

    Temecula, California, 92592

  • Foamix Investigational Site # 120

    Troy, Michigan, 48084

  • Foamix Investigational Site # 140

    Warren, Michigan, 48088

  • Foamix Investigational Site # 229

    Watertown, Massachusetts, 02472

  • Foamix Investigational Site # 209

    Webster, Texas, 77598

  • Foamix Investigational Site # 124

    West Palm Beach, Florida, 33409

  • Foamix Investigational Site # 234

    Winston-Salem, North Carolina, 27103

  • Foamix Investigational Site # 129

    Yardley, Pennsylvania, 19067

Other trials in United States

About this study

Official title: An Open-Label Study to Evaluate the Long-Term Safety of Topical Administration of FMX103 for 40 Weeks in the Treatment of Moderate to Severe Facial Papulopustular Rosacea (Study FX2016-13)

The primary objective is to show that open-label extended treatment with FMX103 1.5%, for up to an additional 40 weeks, is safe and well tolerated.

Read the detailed description

This is an open-label, multicenter, 40-week extension study to evaluate the long-term safety, tolerability, and efficacy of FMX103 1.5% topical foam in the treatment of moderate-to-severe facial papulopustular rosacea. Subjects entering this study will have recently participated in 1 of 2 pivotal, double-blind, vehicle-controlled, safety and efficacy studies (FX2016-11 and FX2016-12 - NCT03142451). Subjects must demonstrate that they are eligible to continue into Study FX2016-13 based on safety evaluations and IGA score performed at Final Visit of one of the previous double-blind studies.

At the completion of the Final Visit in Study FX2016-11 or Study FX2016-12, subjects may be invited to continue into this open-label study for an additional 40 weeks of open-label treatment. A minimum of 400 subjects will be enrolled into from Studies FX2016-11 and FX2016-12. Subjects who elect to continue into this open-label study will receive supplies of active FMX103 1.5% minocycline foam.

Being tested
FMX103 1.5%
Medical subject headings
Rosacea

What participants receive

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

  • FMX103 1.5%Drug

    FMX103 1.5% minocycline foam

Study groups in NCT03276936
Study groupRoleWhat they receive
Minocycline Foam 1.5%ExperimentalFMX-103
Receives: Drug: FMX103 1.5%

What is being measured

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

  1. Absolute Change From Baseline in Inflammatory Lesion Count at Week 40

    Change from Baseline (Baseline visit in the initial DB study [FX2016-11 or FX2016-12] and Baseline visit of the open-label extension study [Week 12]) in inflammatory lesion count at Week 40 is reported. The lesion counts performed at Week 12 [Final Visit] in Study FX2016-11 or Study FX2016-12 constituted as the Baseline value for this study. Changes from Baseline were calculated as the Baseline [pre-dose] value minus the post-Baseline value, so that decreases reflected a reduction in lesion count. The number of papules, pustules, and nodules were counted, and the numbers recorded.

    Measured: Day 0/ Baseline (Final visit of previous DB study [Week 12]) and at Week 40

  2. Percentage of Participants Achieving Investigator's Global Assessments (IGA) Treatment Success at Week 40

    The IGA scale for Rosacea, was used by the Investigators to assess the severity of a participant's Rosacea. The scale ranges from 0 (Clear): No inflammatory papules or pustules to 4 (Severe): Many inflammatory papules or pustules, and up to 2 nodules. 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: At Week 40

Secondary outcomes (5)

  1. Absolute Change From Baseline in Inflammatory Lesion Count at Weeks 4, 10, 16, 22, 28, and 34

    Change from Baseline (Baseline visit in the initial DB study [FX2016-11 or FX2016-12] and Baseline visit of the open-label extension study [Week 12]) in inflammatory lesion count at Week 40 is reported. The lesion counts performed at Week 12 [Final Visit] in Study FX2016-11 or Study FX2016-12 constituted as the Baseline value for this study. Changes from Baseline were calculated as the Baseline [pre-dose] value minus the post-Baseline value, so that decreases reflected a reduction in lesion count. The number of papules, pustules, and nodules were counted, and the numbers recorded.

    Measured: Day 0/ Baseline (Final visit of previous DB study [Week 12]) and at Weeks 4, 10, 16, 22, 28, and 34

  2. Percentage of Participants Achieving IGA Treatment Success at Weeks 4, 10, 16, 22, 28 and 34

    The IGA scale for Rosacea, was used by the Investigators to assess the severity of a participant's Rosacea. The scale ranges from 0 (Clear): No inflammatory papules or pustules to 4 (Severe): Many inflammatory papules or pustules, and up to 2 nodules. 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: At Weeks 4, 10, 16, 22, 28 and Week 34

  3. Percentage Change From Baseline in Inflammatory Lesion Count at Weeks 4, 10, 16, 22, 28, and 34

    Change from Baseline (Baseline visit in the initial DB study [FX2016-11 or FX2016-12] and Baseline visit of the open-label extension study [Week 12]) in inflammatory lesion count at Week 40 is reported. The lesion counts performed at Week 12 [Final Visit] in Study FX2016-11 or Study FX2016-12 constituted as the Baseline value for this study. Changes from Baseline were calculated as the Baseline [pre-dose] value minus the post-Baseline value, so that decreases reflected a reduction in lesion count. The number of papules, pustules, and nodules were counted, and the numbers recorded.

    Measured: Day 0/ Baseline (Final visit of previous DB study [Week 12]) and at Weeks 4, 10, 16, 22, 28, and 34

  4. Number of Participants Reporting Satisfaction and Dissatisfaction With the Study Drug Based on Subject Satisfaction Questionnaire (SSQ) at Week 40

    The questionnaire consisted of questions with responses on scale with scores: as 1 (Very satisfied or Very likely ) to 5 (Very dissatisfied or Very unlikely) for each variable as for example, Easy to use, 1 is very satisfied and 5 is very dissatisfied. The minimum score represented best outcome and higher score represented worst outcome.

    Measured: At Week 40

  5. Number of Participants With Adverse Events (AEs)

    Evaluation of the long-term safety of topical FMX103 1.5% minocycline foam in the treatment of moderate to severe facial papulopustular rosacea for 40 weeks. A Treatment-emergent Adverse Events (TEAEs) was defined as any AE with an onset date after the first dose date of the open-label extension study and before the last application of study drug plus 3 days having been absent pre-treatment or worsened relative to the pre-treatment state.

    Measured: Day 0/ Baseline (Final visit of previous DB study [Week 12]) until safety follow-up (Week 44)

Timeline

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

  1. First posted8 Sep 2017
  2. Study start5 Sep 2017
  3. Primary completion3 Jan 2019
  4. Study completion15 Jan 2019

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
504 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03276936
Sponsor's protocol ID
FX2016-13
Status last verified
Jan 2022
First submitted
21 Aug 2017
Last updated
18 Jan 2022
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing FMX103 1.5% in people with Papulopustular Rosacea, run by Vyne Therapeutics Inc. at 79 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 2 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 79 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. 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 29 Dec 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 Inflammatory Lesion Count at Week 40 (time frame: Day 0/ Baseline (Final visit of previous DB study [Week 12]) and at Week 40). 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 NCT03276936.

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.

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