A Phase 3 interventional study of FMX103 1.5% in Papulopustular Rosacea, sponsored by Vyne Therapeutics Inc.. Completed at 79 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-18.
Sponsored by Vyne Therapeutics Inc. · Phase 3, Interventional, and Treatment
Among 145 studies in Rosacea with a site in United States — 8 open to participants now, 9 under way, none of them phase 3. Rosacea · United States.
Among the 145 studies in Rosacea with a site in United States, this one is the 18th largest by enrollment of the 137 interventional ones that give a count, is one of 17 that started in 2017, is one of 32 in phase 3, and was the 92nd registered.
233 studies on the registry are indexed under Rosacea; 23 are open to participants now.
Browse Rosacea studies →8 of the 145 studies in Rosacea with a site in United States are open now. Recruiting first, the newest first:
Novartis Pharmaceuticals · Sites in United States, Bulgaria, Canada and 6 more countries
Brigham and Women's Hospital · Sites in United States
Narrows Institute for Biomedical Research · Sites in United States
University of Miami · Sites in United States
Wright State University · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 17 Rosacea studies recruiting now, 9 (53%) set no upper age limit and 7 (41%) stop at 75 or younger; 1 take children under 18; 8 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
145 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 25 · Phase 2 44 · Phase 3 34 · Phase 4 20
First in 2002; this study’s year is marked. 17 started in 2017.
This study's enrollment of 504 is above the median of 61 across 200 interventional studies indexed under Rosacea.
Median enrollment 78 across the 137 interventional studies, 236 across the 8 observational. Of the 127 that completed or were terminated, 76 (60%) have results posted.
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98 of 145 have an industry lead sponsor. The 10 most frequent:
Vyne Therapeutics Inc. is the lead sponsor of 32 studies on the registry; none are open to participants now.
Of its 22 completed or terminated interventional studies of FDA-regulated products, 13 (59%) have results posted.
Vyne Therapeutics Inc. has 5 studies filed under Rosacea — fewer than ten, so there is no comparison to draw.
3 of the studies in Rosacea with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07443202Tarsus Pharmaceuticals, Inc.Study of Lotilaner Ophthalmic Gel in Patients With Ocular Rosacea (KORE) | 2026-12-31 |
| NCT06801717University of MiamiRosacea Radiofrequency Microneedling | 2027-07-01 |
| NCT04108897Johns Hopkins UniversityAnalysis of the Microbiome in Rosacea | 2027-09 |
Among the 145 studies in Rosacea with a site in United States, from their registry updates:
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
FMX-103
Drug: FMX103 1.5%
FMX103 1.5% minocycline foam
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.
Time frame: Day 0/ Baseline (Final visit of previous DB study [Week 12]) and at Week 40
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.
Time frame: At Week 40
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.
Time frame: Day 0/ Baseline (Final visit of previous DB study [Week 12]) and at Weeks 4, 10, 16, 22, 28, and 34
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.
Time frame: At Weeks 4, 10, 16, 22, 28 and Week 34
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.
Time frame: Day 0/ Baseline (Final visit of previous DB study [Week 12]) and at Weeks 4, 10, 16, 22, 28, and 34
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.
Time frame: At Week 40
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.
Time frame: Day 0/ Baseline (Final visit of previous DB study [Week 12]) until safety follow-up (Week 44)
This open-label, multi-center, 40-week extension study was conducted at 70 sites in the United States from 05 September 2017 to 03 January 2019, and enrolled participants from previous double-blind (DB) studies FX2016-11 and FX2016-12.
| Milestone | DB-FMX103 1.5% Minocycline Foam | DB-Vehicle Foam |
|---|---|---|
| Started | 332 | 172 |
| Completed | 276 | 134 |
| Not completed | 56 | 38 |
| Withdrew: Adverse event | 4 | 2 |
| Withdrew: Lost to follow-up | 16 | 13 |
| Withdrew: Withdrawal by subject | 30 | 20 |
| Withdrew: Not mentioned | 6 | 3 |
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.
| Lesions | DB-FMX103 1.5% Minocycline Foam | DB-Vehicle Foam |
|---|---|---|
| Absolute Change From Baseline in Inflammatory Lesion Count at Week 40 | 23.0 ± 10.96 | 22.5 ± 10.83 |
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.
| Percentage of participants | DB-FMX103 1.5% Minocycline Foam | DB-Vehicle Foam |
|---|---|---|
| Percentage of Participants Achieving Investigator's Global Assessments (IGA) Treatment Success at Week 40 | 81.6 | 76.0 |
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.
| Lesions | DB-FMX103 1.5% Minocycline Foam | DB-Vehicle Foam |
|---|---|---|
| Week 4 | 19.5 ± 11.57 | 17.4 ± 12.18 |
| Week 10 | 20.4 ± 11.62 | 19.8 ± 12.92 |
| Week 16 | 21.9 ± 11.38 | 20.0 ± 13.09 |
| Week 22 | 22.2 ± 12.35 | 20.7 ± 11.33 |
| Week 28 | 22.4 ± 11.89 | 21.7 ± 10.89 |
| Week 34 | 23.2 ± 11.75 | 22.5 ± 10.71 |
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.
| Percentage of participants | DB-FMX103 1.5% Minocycline Foam | DB-Vehicle Foam |
|---|---|---|
| Week 4 | 50.6 | 48.2 |
| Week 10 | 60.1 | 54.5 |
| Week 16 | 68.1 | 64.0 |
| Week 22 | 69.1 | 64.4 |
| Week 28 | 72.4 | 65.9 |
| Week 34 | 73.5 | 72.1 |
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.
| Percent Change | DB-FMX103 1.5% Minocycline Foam | DB-Vehicle Foam |
|---|---|---|
| Week 4 | 67.91 ± 27.569 | 61.25 ± 32.306 |
| Week 10 | 72.43 ± 27.937 | 69.02 ± 32.966 |
| Week 16 | 77.36 ± 22.739 | 71.46 ± 33.230 |
| Week 22 | 77.51 ± 25.101 | 73.63 ± 27.515 |
| Week 28 | 78.82 ± 23.439 | 77.06 ± 25.863 |
| Week 34 | 81.91 ± 20.549 | 80.38 ± 22.873 |
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.
| Participants | DB-FMX103 1.5% Minocycline Foam | DB-Vehicle Foam |
|---|---|---|
| Easy to Use; 1-Very satisfied | 178 | 82 |
| Easy to Use; 5-Very dissatisfied | 0 | 2 |
| Feel on Skin; 1-Very satisfied | 110 | 47 |
| Feel on Skin; 5-Very dissatisfied | 3 | 3 |
| Odor; 1-Very satisfied | 155 | 78 |
| Odor; 5-Very dissatisfied | 0 | 0 |
| Color; 1-Very satisfied | 107 | 44 |
| Color; 5-Very dissatisfied | 10 | 7 |
| Ease of application; 1-Very satisfied | 183 | 88 |
| Ease of application; 5-Very dissatisfied | 0 | 0 |
| Ease fitting in to daily routine; 1-Very satisfied | 155 | 83 |
| Ease fitting in to daily routine; 5-Very dissatisfied | 0 | 0 |
| Compared to Other Products;1-Very satisfied | 144 | 70 |
| Compared to Other Products; 5-Very dissatisfied | 1 | 2 |
| Use with other rosacea treatments; 1-Very likely | 153 | 74 |
| Use with other rosacea treatments; 5-Very unlikely | 3 | 5 |
| Recommend to friend; 1-Very likely | 156 | 75 |
| Recommend to friend; 5-Very unlikely | 3 | 1 |
| Overall Satisfaction with Product; 1-Very satisfied | 155 | 75 |
| Overall Satisfaction with Product; 5-Very dissatisfied | 2 | 1 |
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.
| Participants | DB-FMX103 1.5% Minocycline Foam | DB-Vehicle Foam |
|---|---|---|
| All AEs | 151 | 70 |
| TEAEs | 137 | 64 |
| Serious TEAEs | 9 | 4 |
| Treatment-related TEAEs | 5 | 8 |
| Adverse events leading to study discontinuation | 3 | 2 |
| Participants with any severe TEAE | 6 | 6 |
| Death | 1 | 0 |
Collected over Day 0/ Baseline (Final visit of previous DB study [Week 12]) until safety follow-up (Week 44). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Minocycline Foam 1.5% | 1/332 (0.3%) | 9/332 (2.7%) | 8/332 (2.4%) |
| Vehicle Foam | 0/172 (0%) | 4/172 (2.3%) | 11/172 (6.4%) |
| Event | Minocycline Foam 1.5% | Vehicle Foam |
|---|---|---|
| Appendicitis perforatedInfections and infestations | 0/332 | 1/172 |
| Post procedural haemorrhageInjury, poisoning and procedural complications | 0/332 | 1/172 |
| Large intestinal obstructionGastrointestinal disorders | 0/332 | 1/172 |
| Respiratory, thoracic and mediastinal disordersRespiratory, thoracic and mediastinal disorders | 0/332 | 1/172 |
| LabyrinthitisInfections and infestations | 1/332 | 0/172 |
| Periorbital cellulitisInfections and infestations | 1/332 | 0/172 |
| PneumoniaInfections and infestations | 1/332 | 0/172 |
| Staphylococcal infectionInfections and infestations | 1/332 | 0/172 |
| Cerebrospinal fluid leakageNervous system disorders | 1/332 | 0/172 |
| Cerebrovascular accidentNervous system disorders | 1/332 | 0/172 |
| Event | Minocycline Foam 1.5% | Vehicle Foam |
|---|---|---|
| SinusitisInfections and infestations | 8/332 | 11/172 |
All treated population included all participants who used the study drug at least once.
| Age, Continuous(Years) | DB-FMX103 1.5% Minocycline Foam | DB-Vehicle Foam | Total |
|---|---|---|---|
| Mean | 51.1 ± 12.62 | 51.9 ± 11.90 | 51.4 ± 12.37 |
| Sex: Female, Male(Participants) | DB-FMX103 1.5% Minocycline Foam | DB-Vehicle Foam | Total |
|---|---|---|---|
| Female | 241 | 110 | 351 |
| Male | 91 | 62 | 153 |
| Ethnicity (NIH/OMB)(Participants) | DB-FMX103 1.5% Minocycline Foam | DB-Vehicle Foam | Total |
|---|---|---|---|
| Hispanic or Latino | 62 | 31 | 93 |
| Not Hispanic or Latino | 269 | 141 | 410 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Race (NIH/OMB)(Participants) | DB-FMX103 1.5% Minocycline Foam | DB-Vehicle Foam | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 3 | 4 | 7 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 5 | 3 | 8 |
| White | 321 | 163 | 484 |
| More than one race | 2 | 0 | 2 |
| Unknown or Not Reported | 0 | 1 | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Sep 2017 to primary completion in Jan 2019, 15 months.
Results were first posted in Dec 2020, 1 year 11 months after primary completion. A results delay was requested in Feb 2020.
Of 17 phase 3 interventional studies under Rosacea, half reached primary completion within 11 months of starting (the median); a quarter within 9 and three quarters within 15. This study's 15 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: FMX103