Trial · NCT03271021
A Study to Evaluate the Efficacy and Safety of Topical Administration of FMX101 in the Treatment of Moderate-to-Severe Acne Vulgaris
NCT03271021, Phase 3, Completed, Vyne Therapeutics Inc.; results first posted 2020-02-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Evaluate the Efficacy and Safety of Topical Administration of FMX101 in the Treatment of Moderate-to-Severe Acne Vulgaris. Trials, record NCT03271021. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03271021
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Efficacy and Safety of Topical Administration of FMX101 in the Treatment of Moderate-to-Severe Acne Vulgaris
- NCT number
- NCT03271021
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,488 participants, actual
- Lead sponsor
- Vyne Therapeutics Inc.
- Conditions
- Acne Vulgaris
- Interventions
- FMX101, Vehicle Foam
- First posted
- 2017-09-01
- Last updated
- 2022-01-18
- Results first posted
- 2020-02-21
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 12. | 12 weeks | A decrease in the inflammatory lesion count from Baseline to Week 12. |
| Primary | 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 | 12 weeks | |
| Secondary | The Absolute Change From Baseline in the Non-inflammatory Lesion Count at Week 12 | 12 weeks | |
| Secondary | The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 9 | 9 weeks | |
| Secondary | The Absolute Change From Baseline in the Inflammatory Lesion Count at the Interim Visit at Week 6 | 6 weeks | |
| Secondary | 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 | 6 weeks | |
| Secondary | 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 | 9 weeks |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 12. | 12 weeks | Lesion Count | LEAST_SQUARES_MEAN | |
| PRIMARY | 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 | 12 weeks | participants | NUMBER | |
| SECONDARY | The Absolute Change From Baseline in the Non-inflammatory Lesion Count at Week 12 | 12 weeks | Lesion Count | LEAST_SQUARES_MEAN | |
| SECONDARY | The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 9 | 9 weeks | Lesion Count | LEAST_SQUARES_MEAN | |
| SECONDARY | The Absolute Change From Baseline in the Inflammatory Lesion Count at the Interim Visit at Week 6 | 6 weeks | Lesion Count | LEAST_SQUARES_MEAN | |
| SECONDARY | 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 | 6 weeks | participants | NUMBER | |
| SECONDARY | 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 | 9 weeks | participants | NUMBER |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 12. | FMX101, 4% Minocycline Foam | 16.39 | 95% Confidence Interval 15.53 to 17.25 | Lesion Count | |
| The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 12. | Vehicle Foam | 12.74 | 95% Confidence Interval 11.88 to 13.61 | Lesion Count | |
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 | FMX101, 4% Minocycline Foam | 199 | participants | ||
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 | Vehicle Foam | 133 | participants | ||
| The Absolute Change From Baseline in the Non-inflammatory Lesion Count at Week 12 | FMX101, 4% Minocycline Foam | 18.80 | 95% Confidence Interval 17.06 to 20.54 | Lesion Count | |
| The Absolute Change From Baseline in the Non-inflammatory Lesion Count at Week 12 | Vehicle Foam | 15.89 | 95% Confidence Interval 14.14 to 17.65 | Lesion Count | |
| The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 9 | FMX101, 4% Minocycline Foam | 15.59 | 95% Confidence Interval 14.80 to 16.38 | Lesion Count | |
| The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 9 | Vehicle Foam | 11.72 | 95% Confidence Interval 10.92 to 12.52 | Lesion Count | |
| The Absolute Change From Baseline in the Inflammatory Lesion Count at the Interim Visit at Week 6 | FMX101, 4% Minocycline Foam | 13.09 | 95% Confidence Interval 12.29 to 13.89 | Lesion Count | |
| The Absolute Change From Baseline in the Inflammatory Lesion Count at the Interim Visit at Week 6 | Vehicle Foam | 9.57 | 95% Confidence Interval 8.76 to 110.37 | Lesion Count |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | FMX101, 4% Minocycline Foam | 738 | |
| Overall Study | STARTED | Vehicle Foam | 750 | |
| Overall Study | COMPLETED | FMX101, 4% Minocycline Foam | 649 | |
| Overall Study | COMPLETED | Vehicle Foam | 644 | |
| Overall Study | NOT COMPLETED | FMX101, 4% Minocycline Foam | 89 | |
| Overall Study | NOT COMPLETED | Vehicle Foam | 106 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Cholecystitis | Hepatobiliary disorders | FMX101, 4% Minocycline Foam | 0 | 737 | 0 |
| serious | Cholecystitis | Hepatobiliary disorders | Vehicle Foam | 1 | 747 | 1 |
| serious | Chron's disease | Gastrointestinal disorders | FMX101, 4% Minocycline Foam | 0 | 737 | 0 |
| serious | Chron's disease | Gastrointestinal disorders | Vehicle Foam | 3 | 747 | 3 |
| serious | Pregnancy | Pregnancy, puerperium and perinatal conditions | FMX101, 4% Minocycline Foam | 1 | 737 | 1 |
| serious | Pregnancy | Pregnancy, puerperium and perinatal conditions | Vehicle Foam | 1 | 747 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | FMX101, 4% Minocycline Foam | 0 | 737 |
| Total, all-cause mortality | Vehicle Foam | 0 | 747 |
| Total, other adverse events | FMX101, 4% Minocycline Foam | 0 | 737 |
| Total, other adverse events | Vehicle Foam | 0 | 747 |
| Total, serious adverse events | FMX101, 4% Minocycline Foam | 1 | 737 |
| Total, serious adverse events | Vehicle Foam | 4 | 747 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
FMX101, 4% Minocycline Foam vs 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 | Trial comparisons |
FMX101, 4% Minocycline Foam vs 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 | Trial comparisons |
FMX101, 4% Minocycline Foam vs 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 | Trial comparisons |
| FMX101, 4% Minocycline Foam vs Vehicle Foam: deaths from any cause | Trial comparisons |
| FMX101, 4% Minocycline Foam vs Vehicle Foam: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03271021
GET https://conductscience.org/api/trials/v1/NCT03271021/registered