A Phase 3 interventional study of FMX101 and Vehicle Foam in Acne Vulgaris, sponsored by Vyne Therapeutics Inc.. Completed at 98 sites in United States. Open to participants aged 9 Years and older. Per ClinicalTrials.gov, last updated 2022-01-18.
Sponsored by Vyne Therapeutics Inc. · Phase 3, Interventional, and Treatment
Among 372 studies in Acne Vulgaris with a site in United States — 19 open to participants now, 28 under way, 2 of them phase 3. Acne Vulgaris · United States.
Among the 372 studies in Acne Vulgaris with a site in United States, this one is the 8th largest by enrollment of the 352 interventional ones that give a count, is one of 23 that started in 2017, is one of 76 in phase 3, and was the 234th registered.
790 studies on the registry are indexed under Acne Vulgaris; 93 are open to participants now.
Browse Acne Vulgaris studies →19 of the 372 studies in Acne Vulgaris with a site in United States are open now. Recruiting first, the newest first:
Sagimet Biosciences Inc. · Sites in United States
Integrative Skin Science and Research · Sites in United States
Bausch Health Americas, Inc. · Sites in United States
Sanofi Pasteur, a Sanofi Company · Sites in United States
Sagimet Biosciences Inc. · Sites in United States, Australia
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 47 Acne Vulgaris studies recruiting now, 17 (36%) set no upper age limit and 29 (62%) stop at 75 or younger; 21 take children under 18; 17 take healthy volunteers.
This study: 9 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.
372 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 58 · Phase 2 82 · Phase 3 82 · Phase 4 71
First in 2002; this study’s year is marked. 23 started in 2017.
This study's enrollment of 1,488 is above the median of 70 across 672 interventional studies indexed under Acne Vulgaris.
Median enrollment 79 across the 352 interventional studies, 59 across the 19 observational. Of the 322 that completed or were terminated, 189 (59%) have results posted.
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285 of 372 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 7 studies filed under Acne Vulgaris — fewer than ten, so there is no comparison to draw.
8 of the studies in Acne Vulgaris with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07863193Phase 3Sagimet Biosciences Inc.Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA) | 2027-08 |
| NCT06315166PollogenStudy on Using Radiofrequency to Treat Moderate to Severe Acne | 2026-12 |
| NCT02713607University of California, DavisLipidome and Microbiome Profile of Acne | 2027-01 |
| NCT06989840Sagimet Biosciences Inc.Phase 1 Study to Evaluate the Safety, Tolerability, PK, and PD of TVB-3567 in Healthy Participants With or Without Acne | 2027-01 |
| NCT07896486Weill Medical College of Cornell UniversityEvaluating a Brightening Serum for Post-Inflammatory Hyperpigmentation | 2027-01-15 |
Among the 372 studies in Acne Vulgaris with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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)
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:
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.
Has facial acne vulgaris with:
Exclusion Criteria:
FMX101, 4% minocycline foam applied topically once daily for 12 weeks
Drug: FMX101
Vehicle foam applied topically once daily for 12 weeks
Drug: Vehicle Foam
FMX101, 4% minocycline foam
Vehicle Foam
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.
Time frame: 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
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
| Milestone | FMX101, 4% Minocycline Foam | Vehicle Foam |
|---|---|---|
| Started | 738 | 750 |
| Completed | 649 | 644 |
| Not completed | 89 | 106 |
| Withdrew: Adverse event | 3 | 2 |
| Withdrew: Withdrawal by subject | 36 | 53 |
| Withdrew: Lost to follow-up | 34 | 39 |
| Withdrew: Protocol violation | 6 | 4 |
| Withdrew: Abnormal lab results | 1 | 0 |
| Withdrew: Miscellaneous | 9 | 8 |
A decrease in the inflammatory lesion count from Baseline to Week 12.
| Lesion Count | FMX101, 4% Minocycline Foam | Vehicle Foam |
|---|---|---|
| The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 12. | 16.39 (15.53 to 17.25) | 12.74 (11.88 to 13.61) |
| participants | FMX101, 4% Minocycline Foam | Vehicle Foam |
|---|---|---|
| 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 | 199 | 133 |
| Lesion Count | FMX101, 4% Minocycline Foam | Vehicle Foam |
|---|---|---|
| The Absolute Change From Baseline in the Non-inflammatory Lesion Count at Week 12 | 18.80 (17.06 to 20.54) | 15.89 (14.14 to 17.65) |
| Lesion Count | FMX101, 4% Minocycline Foam | Vehicle Foam |
|---|---|---|
| The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 9 | 15.59 (14.80 to 16.38) | 11.72 (10.92 to 12.52) |
| Lesion Count | FMX101, 4% Minocycline Foam | Vehicle Foam |
|---|---|---|
| The Absolute Change From Baseline in the Inflammatory Lesion Count at the Interim Visit at Week 6 | 13.09 (12.29 to 13.89) | 9.57 (8.76 to 110.37) |
| participants | FMX101, 4% Minocycline Foam | Vehicle Foam |
|---|---|---|
| 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 | 84 | 46 |
| participants | FMX101, 4% Minocycline Foam | Vehicle Foam |
|---|---|---|
| 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 | 137 | 79 |
Collected over Up to 16 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| FMX101, 4% Minocycline Foam | 0/737 (0%) | 1/737 (0.1%) | 0/737 (0%) |
| Vehicle Foam | 0/747 (0%) | 4/747 (0.5%) | 0/747 (0%) |
| Event | FMX101, 4% Minocycline Foam | Vehicle Foam |
|---|---|---|
| Chron's diseaseGastrointestinal disorders | 0/737 | 3/747 |
| PregnancyPregnancy, puerperium and perinatal conditions | 1/737 | 1/747 |
| CholecystitisHepatobiliary disorders | 0/737 | 1/747 |
| Age, Customized(Participants) | FMX101, 4% Minocycline Foam | Vehicle Foam | Total |
|---|---|---|---|
| 9-12 | 42 | 41 | 83 |
| 13-17 | 321 | 309 | 630 |
| ≥ 18 | 375 | 400 | 775 |
| Sex: Female, Male(Participants) | FMX101, 4% Minocycline Foam | Vehicle Foam | Total |
|---|---|---|---|
| Female | 460 | 469 | 929 |
| Male | 278 | 281 | 559 |
| Ethnicity (NIH/OMB)(Participants) | FMX101, 4% Minocycline Foam | Vehicle Foam | Total |
|---|---|---|---|
| Hispanic or Latino | 266 | 252 | 518 |
| Not Hispanic or Latino | 472 | 498 | 970 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | FMX101, 4% Minocycline Foam | Vehicle Foam | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 3 | 4 |
| Asian | 25 | 29 | 54 |
| Native Hawaiian or Other Pacific Islander | 2 | 4 | 6 |
| Black or African American | 125 | 144 | 269 |
| White | 571 | 560 | 1131 |
| More than one race | 14 | 10 | 24 |
| Unknown or Not Reported | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jul 2017 to primary completion in Sep 2018, 13 months.
Results were first posted in Feb 2020, 1 year 5 months after primary completion.
Of 53 industry-sponsored phase 3 interventional studies under Acne Vulgaris, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 17. This study's 13 months is close to that.
Counting every sponsor, half of 62 studies reached it within 13 months; a quarter within 10 and three quarters within 17.
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: FMX101