Trial · NCT04608500
A Study (Study 2) to Evaluate the Safety and Efficacy of FMX103 1.5% Topical Minocycline Foam in the Treatment of Facial Papulopustular Rosacea
NCT04608500, Phase 3, Completed, Vyne Therapeutics Inc.; results first posted 2020-12-16
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study (Study 2) to Evaluate the Safety and Efficacy of FMX103 1.5% Topical Minocycline Foam in the Treatment of Facial Papulopustular Rosacea. Trials, record NCT04608500. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04608500
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study (Study 2) to Evaluate the Safety and Efficacy of FMX103 1.5% Topical Minocycline Foam in the Treatment of Facial Papulopustular Rosacea
- NCT number
- NCT04608500
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 771 participants, actual
- Lead sponsor
- Vyne Therapeutics Inc.
- Conditions
- Facial Papulopustular Rosacea
- Interventions
- FMX103 minocycline foam 1.5%, Vehicle foam
- First posted
- 2020-10-29
- Last updated
- 2021-01-07
- Results first posted
- 2020-12-16
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 Day 0/Baseline in the Inflammatory Lesion Count at Week 12 | Baseline and Week 12 | To determine the efficacy of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea. Lesion counts included the number of papules, pustules, and nodules. Change from Baseline was calculated as the value at Baseline minus the post-Baseline value. Thus, a positive change reflects a reduction in lesion count. |
| Primary | Percentage of Participants Achieving Investigator Global Assessments (IGA) Treatment Success at Week 12 | Week 12 | To determine the efficacy of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea. The Investigator assessed the global severity of rosacea using the IGA scale. 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 (clear) or 1 (almost clear), and at least a 2-step improvement (decrease) from Day 0/Baseline. |
| Secondary | Percentage of Participants Achieving IGA Treatment Success of at Least 2 Grades at Week 12 | Week 12 | To determine the efficacy of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea. The Investigator assessed the global severity of rosacea using the IGA scale. 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 a 2-grade improvement (decrease) in score at Week 12 compared to Day 0/Baseline. |
| Secondary | The Percent Change From Day 0/Baseline in Inflammatory Lesion Count at Week 12 | Baseline and Week 12 | To determine the efficacy of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea. Lesion counts included the number of papules, pustules, and nodules. |
| Secondary | The Absolute Change From Day 0/Baseline in the Inflammatory Lesion Counts at Week 4 and Week 8 | Baseline, Week 4 and Week 8 | To determine the efficacy of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea. Lesion counts included the number of papules, pustules, and nodules. Change from Baseline was calculated as the value at Baseline minus the post-Baseline value. Thus, a positive change reflects a reduction in lesion count. |
| Secondary | Percentage of Participants Achieving IGA Treatment Success at Week 4 and Week 8 | Week 4 and Week 8 | To determine the efficacy of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea. The Investigator assessed the global severity of rosacea using the IGA scale. 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 (clear) or 1 (almost clear), and at least a 2-grade improvement (decrease) from Day 0/Baseline. |
| Secondary | Number of Participants With Adverse Events (AEs) | From Day 0/Baseline until the Safety Follow-up (4 weeks after Week 12 [Final Visit]) | To evaluate the tolerability and safety of topical minocycline foam applied once daily for 12 weeks. A Treatment-emergent adverse events (TEAE) was defined as any AE with an onset date on or after the first application of study drug, and before to the last application of study drug plus 3 days, having been absent pre-treatment or worsening relative to the pre-treatment state. |
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 Day 0/Baseline in the Inflammatory Lesion Count at Week 12 | Baseline and Week 12 | The intent to treat (ITT) population included all randomized participants. Analyses using the ITT population were based on the randomized treatment. | Lesions | LEAST_SQUARES_MEAN |
| PRIMARY | Percentage of Participants Achieving Investigator Global Assessments (IGA) Treatment Success at Week 12 | Week 12 | The ITT population included all randomized participants. Analyses using the ITT population were based on the randomized treatment. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving IGA Treatment Success of at Least 2 Grades at Week 12 | Week 12 | The ITT population included all randomized participants. Analyses using the ITT population were based on the randomized treatment.~Here, overall number of participants analyzed signifies only the participants with available data that were analyzed for the outcome measure. | Percentage of participants | NUMBER |
| SECONDARY | The Percent Change From Day 0/Baseline in Inflammatory Lesion Count at Week 12 | Baseline and Week 12 | The ITT population included all randomized participants. Analyses using the ITT population were based on the randomized treatment.~Here, overall number of participants analyzed signifies only the participants with available data that were analyzed for the outcome measure. | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | The Absolute Change From Day 0/Baseline in the Inflammatory Lesion Counts at Week 4 and Week 8 | Baseline, Week 4 and Week 8 | The ITT population included all randomized participants. Analyses using the ITT population were based on the randomized treatment. | Lesions | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Achieving IGA Treatment Success at Week 4 and Week 8 | Week 4 and Week 8 | The ITT population included all randomized participants. Analyses using the ITT population were based on the randomized treatment. | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Adverse Events (AEs) | From Day 0/Baseline until the Safety Follow-up (4 weeks after Week 12 [Final Visit]) | The Safety (SAF) population included all randomized participants who used at least 1 dose of study drug, including participants who had no post-Baseline assessments unless all dispensed study drug was returned unused. Analyses using the SAF population were based on the treatment received. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group30
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 Day 0/Baseline in the Inflammatory Lesion Count at Week 12 | FMX103 1.5% | 18.38 | Standard Error 0.508 | Lesions | |
| The Absolute Change From Day 0/Baseline in the Inflammatory Lesion Count at Week 12 | Vehicle Foam | 14.53 | Standard Error 0.715 | Lesions | |
| Percentage of Participants Achieving Investigator Global Assessments (IGA) Treatment Success at Week 12 | FMX103 1.5% | 49.1 | Percentage of participants | ||
| Percentage of Participants Achieving Investigator Global Assessments (IGA) Treatment Success at Week 12 | Vehicle Foam | 39.0 | Percentage of participants | ||
| Percentage of Participants Achieving IGA Treatment Success of at Least 2 Grades at Week 12 | FMX103 1.5% | 53.8 | Percentage of participants | ||
| Percentage of Participants Achieving IGA Treatment Success of at Least 2 Grades at Week 12 | Vehicle Foam | 45.1 | Percentage of participants | ||
| The Percent Change From Day 0/Baseline in Inflammatory Lesion Count at Week 12 | FMX103 1.5% | 61.45 | Standard Error 1.578 | Percent change | |
| The Percent Change From Day 0/Baseline in Inflammatory Lesion Count at Week 12 | Vehicle Foam | 50.16 | Standard Error 2.221 | Percent change | |
| The Absolute Change From Day 0/Baseline in the Inflammatory Lesion Counts at Week 4 and Week 8 | FMX103 1.5% | Week 4 | 12.67 | Standard Error 0.484 | Lesions |
| The Absolute Change From Day 0/Baseline in the Inflammatory Lesion Counts at Week 4 and Week 8 | Vehicle Foam | Week 4 | 8.29 | Standard Error 0.678 | Lesions |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | FMX103 1.5% | 514 | |
| Overall Study | STARTED | Vehicle Foam | 257 | |
| Overall Study | COMPLETED | FMX103 1.5% | 479 | |
| Overall Study | COMPLETED | Vehicle Foam | 239 | |
| Overall Study | NOT COMPLETED | FMX103 1.5% | 35 | |
| Overall Study | NOT COMPLETED | Vehicle Foam | 18 |
Source ClinicalTrials.gov
Adverse events14
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 |
|---|---|---|---|---|---|---|
| other | Upper respiratory tract infection | Infections and infestations | FMX103 1.5% | 15 | 514 | |
| other | Upper respiratory tract infection | Infections and infestations | Vehicle Foam | 8 | 257 | |
| other | Viral upper respiratory tract infection | Infections and infestations | FMX103 1.5% | 14 | 514 | |
| other | Viral upper respiratory tract infection | Infections and infestations | Vehicle Foam | 8 | 257 | |
| other | Headache | Nervous system disorders | FMX103 1.5% | 11 | 514 | |
| other | Headache | Nervous system disorders | Vehicle Foam | 6 | 257 | |
| serious | Asthma | Respiratory, thoracic and mediastinal disorders | FMX103 1.5% | 0 | 514 | |
| serious | Asthma | Respiratory, thoracic and mediastinal disorders | Vehicle Foam | 1 | 257 | |
| serious | Dyspnoea | Respiratory, thoracic and mediastinal disorders | FMX103 1.5% | 0 | 514 | |
| serious | Dyspnoea | Respiratory, thoracic and mediastinal disorders | Vehicle Foam | 1 | 257 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | FMX103 1.5% | 0 | 514 |
| Total, all-cause mortality | Vehicle Foam | 0 | 257 |
| Total, other adverse events | FMX103 1.5% | 39 | 514 |
| Total, other adverse events | Vehicle Foam | 22 | 257 |
| Total, serious adverse events | FMX103 1.5% | 1 | 514 |
| Total, serious adverse events | Vehicle Foam | 2 | 257 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| FMX103 1.5% vs Vehicle Foam: deaths from any cause | Trial comparisons |
| FMX103 1.5% 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/NCT04608500
GET https://conductscience.org/api/trials/v1/NCT04608500/results?page=2