Facial Papulopustular RosaceaPhase 3NCT04608500
A Study (Study 2) to Evaluate the Safety and Efficacy of FMX103 1.5% Topical Minocycline Foam in the Treatment of Facial Papulopustular Rosacea
A Phase 3 study testing FMX103 minocycline foam 1.5% in people with Facial Papulopustular Rosacea, run by Vyne Therapeutics Inc. at 46 sites in United States.
Trial summary
The primary objectives of this study are to determine the efficacy and safety of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Facial Papulopustular Rosacea
- What is being tested?
- FMX103 minocycline foam 1.5%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 771 participants
- Where
- 46 sitesUnited States
- Study dates
- 1 Jun 2017to 31 Jul 2018
- 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
- Moderate-to-severe rosacea (as per the IGA score) on the proposed facial treatment area consisting of:
- At least 15 and not more than 75 facial papules and pustules, excluding lesions involving the eyes and scalp;
- No more than 2 nodules on the face.
- Presence of or history of erythema and/or flushing on the face.
Who cannot join
- Presence of any skin condition and/or Excessive facial hair, on the face that would interfere with the diagnosis or assessment of rosacea.
- Moderate or severe rhinophyma, dense telangiectasia (score 3, severe), or plaque-like facial edema.
- History of hypersensitivity or allergy to minocycline, any other tetracycline, or of any other component of the formulation.
- Active ocular rosacea (eg, conjunctivitis, blepharitis, or keratitis) of sufficient severity to require topical or systemic antibiotics.
Trial locations and contacts
46 sites in 1 country.
46 sites in 1 country
United States46 sites
Foamix Investigational Site # 219
Arlington, Texas, 76011
Foamix Investigational Site # 211
Arlington Heights, Illinois, 60005
Foamix Investigational Site # 223
Boca Raton, Florida, 33486
Foamix Investigational Site # 215
Boynton Beach, Florida, 33437
Foamix Investigational Site #245
DeLand, Florida, 32720
Foamix Investigational Site # 227
Denver, Colorado, 80209
Foamix Investigational Site # 210
Detroit, Michigan, 48202
Foamix Investigational Site #244
Encino, California, 91436
Foamix Investigational Site # 224
Exton, Pennsylvania, 19341
Foamix Investigational Site # 240
Fort Myers, Florida, 33912
Foamix Investigational Site # 232
Fridley, Minnesota, 55432
Foamix Investigational Site # 207
Glendale, Arizona, 85308
Foamix Investigational Site #247
Hialeah, Florida, 33015
Foamix Investigational Site #252
Hialeah, Florida, 33106
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 #249
Huntington Beach, California, 92647
Foamix Investigational Site # 228
Knoxville, Tennessee, 37922
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 # 214
Miami, Florida, 33126
Foamix Investigational Site #246
Miami, Florida, 33186
Foamix Investigational Site # 230
Mt. Pleasant, South Carolina, 29464
Foamix Investigational Site # 220
Murrieta, California, 92562
Foamix Investigational Site # 225
Newburgh, Indiana, 47630
Foamix Investigational Site # 204
Newnan, Georgia, 78660
Foamix Investigational Site # 236
Norman, Oklahoma, 73071
Foamix Investigational Site #251
North Hollywood, California, 91606
Foamix Investigational Site # 241
North Miami Beach, Florida, 33162
Foamix Investigational Site #248
Oldsmar, Florida, 34677
Foamix Investigational Site # 206
Pflugerville, Texas, 78660
Foamix Investigational Site #243
Plainfield, Indiana, 46168
Foamix Investigational Site # 212
Raleigh, North Carolina, 27612
Foamix Investigational Site # 222
Rogers, Arkansas, 72758
Foamix Investigational Site # 208
San Antonio, Texas, 78229
Foamix Investigational Site # 213
San Antonio, Texas, 78229
Foamix Investigational Site # 217
San Diego, California, 92123
Foamix Investigational Site #250
San Marcos, California, 92078
Foamix Investigational Site # 203
Seattle, Washington, 98104
Foamix Investigational Site # 218
South Bend, Indiana, 46617
Foamix Investigational Site # 239
Temecula, California, 92592
Foamix Investigational Site # 229
Watertown, Massachusetts, 02472
Foamix Investigational Site # 209
Webster, Texas, 77598
About this study
Official title: A Randomized, Multicenter, Double-blind, Vehicle-controlled Study to Evaluate the Safety and Efficacy of FMX103 1.5% Topical Minocycline Foam Compared to Vehicle in the Treatment of Facial Papulopustular Rosacea (FX2016-12)
The primary objectives of this study are to determine the efficacy and safety of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea.
Read the detailed description
This is a randomized, multicenter, double-blind, vehicle-controlled, 2 arm study to evaluate the safety and efficacy of FMX103 topical foam containing 1.5% minocycline compared to vehicle, in the treatment of participants with moderate-to-severe facial papulopustular rosacea. Qualified participants will be randomized in a 2:1 ratio (active:vehicle) to receive 1 of the following 2 treatments:
- FMX103 minocycline foam 1.5%
- Vehicle foam
Participants will be assigned to 1 of 2 treatments according to the randomization schedule. Participants will apply (or have applied) the study drug topically once daily for 12 weeks as directed. Participants will be advised to use the study drug at approximately the same time each day. Both the Investigator and participant will be blinded to the study drug identity. Participants will return for visits at Weeks 1, 4, 6, 8, 10, and 12. Efficacy evaluations (inflammatory lesion counts and Investigator's Global Assessment [IGA] score) will be performed at Weeks 4, 8, and 12 during the study.
Note: Originally the two studies FX2016-11 and FX2016-12 were combinedly presented in the protocol registration form under one NCT number (NCT03142451), and later separated since results were analyzed separately.
- Conditions
- Facial Papulopustular Rosacea
- Being tested
- FMX103 minocycline foam 1.5%, Vehicle foam
- Keywords
- Topical Minocycline Foam, 2-Arm study, Inflammatory lesion counts, Investigator's Global Assessment score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FMX103 minocycline foam 1.5%Drug
Dosage form description: Foam containing minocycline HCl 1.5%. Once daily application of a sufficient amount of foam to cover the entire face. Estimated maximum is 0.5 g of drug product containing 7.5 mg (1.5% active) of minocycline. Participants will apply a small amount of the drug as a thin layer over all areas of the face. Participants should apply the drug at approximately the same time each day, about 1 hour before bedtime.
Vehicle foamDrug
Dosage form description: Foam containing minocycline vehicle foam. Once daily application of a sufficient amount of foam to cover the entire face. Estimated maximum is 0.5 g of drug product containing 0.0 mg (vehicle) of minocycline. Participants will apply a small amount of the drug as a thin layer over all areas of the face. Participants should apply the drug at approximately the same time each day, about 1 hour before bedtime.
| Study group | Role | What they receive |
|---|---|---|
| FMX103 1.5% | Experimental | Participants will apply the assigned FMX103 minocycline foam 1.5% topically once daily for 12 weeks as directed. Receives: Drug: FMX103 minocycline foam 1.5% |
| Vehicle foam | Placebo comparator | Participants will apply the assigned vehicle foam topically once daily for 12 weeks as directed. Receives: Drug: Vehicle foam |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Absolute Change From Day 0/Baseline in the Inflammatory Lesion Count at 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.
Measured: Baseline and Week 12
Percentage of Participants Achieving Investigator Global Assessments (IGA) Treatment Success at 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.
Measured: Week 12
Secondary outcomes (5)
Percentage of Participants Achieving IGA Treatment Success of at Least 2 Grades at 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.
Measured: Week 12
The Percent Change From Day 0/Baseline in Inflammatory Lesion Count at 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.
Measured: Baseline and Week 12
The Absolute Change From Day 0/Baseline in the Inflammatory Lesion Counts at 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.
Measured: Baseline, Week 4 and Week 8
Percentage of Participants Achieving IGA Treatment Success at 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.
Measured: Week 4 and Week 8
Number of Participants With Adverse Events (AEs)
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.
Measured: From Day 0/Baseline until the Safety Follow-up (4 weeks after Week 12 [Final Visit])
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2020
- Study start1 Jun 2017
- Primary completion2 Jul 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Facial Papulopustular RosaceaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 771 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vyne Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Premier Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04608500
- Sponsor's protocol ID
- FX2016-12
- Status last verified
- Dec 2020
- First submitted
- 20 Oct 2020
- Last updated
- 7 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Double-blind, Vehicle-controlled Study to Evaluate the Safety and Efficacy of FMX103 1.5% Topical Minocycline Foam Compared to Vehicle in the Treatment of Facial Papulopustular Rosacea (FX2016-12)
- ClinicalTrials.gov ID
- NCT04608500
- Acronym / sponsor ID
- FX2016-12
- Conditions
- Facial Papulopustular Rosacea
- Keywords
- Topical Minocycline Foam, 2-Arm study, Inflammatory lesion counts, Investigator's Global Assessment score
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 771 participants (actual)
- Lead sponsor
- Vyne Therapeutics Inc.Industry (pharma, biotech, devices)
- Collaborators
- Premier Research
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 2 Jul 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 29 Oct 2020 (actual)
- Results
- Posted 16 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objectives of this study are to determine the efficacy and safety of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea.
Detailed description
This is a randomized, multicenter, double-blind, vehicle-controlled, 2 arm study to evaluate the safety and efficacy of FMX103 topical foam containing 1.5% minocycline compared to vehicle, in the treatment of participants with moderate-to-severe facial papulopustular rosacea. Qualified participants will be randomized in a 2:1 ratio (active:vehicle) to receive 1 of the following 2 treatments:
- FMX103 minocycline foam 1.5%
- Vehicle foam
Participants will be assigned to 1 of 2 treatments according to the randomization schedule. Participants will apply (or have applied) the study drug topically once daily for 12 weeks as directed. Participants will be advised to use the study drug at approximately the same time each day. Both the Investigator and participant will be blinded to the study drug identity. Participants will return for visits at Weeks 1, 4, 6, 8, 10, and 12. Efficacy evaluations (inflammatory lesion counts and Investigator's Global Assessment [IGA] score) will be performed at Weeks 4, 8, and 12 during the study.
Note: Originally the two studies FX2016-11 and FX2016-12 were combinedly presented in the protocol registration form under one NCT number (NCT03142451), and later separated since results were analyzed separately.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FMX103 1.5% | Experimental | Drug: FMX103 minocycline foam 1.5%Participants will apply the assigned FMX103 minocycline foam 1.5% topically once daily for 12 weeks as directed. |
| Vehicle foam | Placebo comparator | Drug: Vehicle foamParticipants will apply the assigned vehicle foam topically once daily for 12 weeks as directed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Moderate-to-severe rosacea (as per the IGA score) on the proposed facial treatment area consisting of:
- Presence of or history of erythema and/or flushing on the face.
Key exclusion criteria (4 listed)
- Presence of any skin condition and/or Excessive facial hair, on the face that would interfere with the diagnosis or assessment of rosacea.
- Moderate or severe rhinophyma, dense telangiectasia (score 3, severe), or plaque-like facial edema.
- History of hypersensitivity or allergy to minocycline, any other tetracycline, or of any other component of the formulation.
- Active ocular rosacea (eg, conjunctivitis, blepharitis, or keratitis) of sufficient severity to require topical or systemic antibiotics.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FMX103 minocycline foam 1.5%Dosage form description: Foam containing minocycline HCl 1.5%. Once daily application of a sufficient amount of foam to cover the entire face. Estimated maximum is 0.5 g of drug product containing 7.5 mg (1.5% active) of minocycline. Participants will apply a small amount of the drug as a thin layer over all areas of the face. Participants should apply the drug at approximately the same time each day, about 1 hour before bedtime. | Drug | FMX103 1.5% |
| Vehicle foamDosage form description: Foam containing minocycline vehicle foam. Once daily application of a sufficient amount of foam to cover the entire face. Estimated maximum is 0.5 g of drug product containing 0.0 mg (vehicle) of minocycline. Participants will apply a small amount of the drug as a thin layer over all areas of the face. Participants should apply the drug at approximately the same time each day, about 1 hour before bedtime. | Drug | Vehicle foam |
Primary outcome
The Absolute Change From Day 0/Baseline in the Inflammatory Lesion Count at Week 12
Time frame: 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.
Percentage of Participants Achieving Investigator Global Assessments (IGA) Treatment Success at Week 12
Time frame: 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.
5 secondary outcomes
Percentage of Participants Achieving IGA Treatment Success of at Least 2 Grades at Week 12
Time frame: Week 12
The Percent Change From Day 0/Baseline in Inflammatory Lesion Count at Week 12
Time frame: Baseline and Week 12
The Absolute Change From Day 0/Baseline in the Inflammatory Lesion Counts at Week 4 and Week 8
Time frame: Baseline, Week 4 and Week 8
Percentage of Participants Achieving IGA Treatment Success at Week 4 and Week 8
Time frame: Week 4 and Week 8
Number of Participants With Adverse Events (AEs)
Time frame: From Day 0/Baseline until the Safety Follow-up (4 weeks after Week 12 [Final Visit])
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
46 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing FMX103 minocycline foam 1.5% in people with Facial Papulopustular Rosacea, run by Vyne Therapeutics Inc. at 46 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 4 inclusion and 4 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 7 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 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. Some participants in this study may receive a placebo. 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 16 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?
The Absolute Change From Day 0/Baseline in the Inflammatory Lesion Count at Week 12 (time frame: Baseline and Week 12). 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?
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 7 Jan 2021.