RosaceaPhase 2EMIRANCT02601963
Safety and Efficacy Study of a Topical Minocycline Foam in Patients With Papulopustular Rosacea
A Phase 2 study testing FMX-103 1.5% and FMX-103 3% in people with Rosacea and Papulopustular Rosacea, run by Vyne Therapeutics Inc. at 20 sites in Germany.
Trial summary
The purpose of this study is to see if the study drug, FMX-103, is safe to give and if it helps people with moderate-to-severe papulopustular rosacea. The investigational product is FMX-103 minocycline foam. Two concentrations of the investigational product, 1.5% and 3%, will be studied along with vehicle. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rosacea, Papulopustular Rosacea
- What is being tested?
- FMX-103 1.5% and FMX-103 3%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 233 participants
- Where
- 20 sitesGermany
- Study dates
- Sep 2015to Aug 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Participants age is 18 years or older.
- Participants have a moderate-to-severe rosacea excluding lesions involving the eyes and scalp.
- Subject must have diagnosed rosacea for at least 6 months prior to screening.
Who cannot join
- History of hypersensitivity or allergy to minocycline, any other tetracycline or any other component of the formulation such as Soybean oil or Coconut oil.
- Women of child bearing potential who are pregnant, lactating (in the last 3 months) or planning to become pregnant during the study period.
- Moderate or severe rhinophyma, dense telangiectasis (score 3, severe), or plaque- like facial edema.
- Rosacea conglobata or fulminans, corticosteroid-induced rosacea or isolated pustulosis of the chin, facial erythrosis of known origin other than rosacea (e.g., known carcinoid syndrome).
- Ocular rosacea (e.g., conjunctivitis, blepharitis, or keratitis) of sufficient severity to require topical ophthalmic or systemic antibiotics, papulopustular rosacea that requires medically indicated systemic treatment.
- Bacterial folliculitis.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Germany20 sites
Study site
Berlin, 10783
Study site
Berlin, 13055
Study site
Berlin, 13086
Study site
Berlin, 13507
Study site
Blaubeuren Abbey, 89143
Study site
Bochum, 44803
Study site
Buxtehude, 21614
Study site
Darmstadt, 64283
Study site
Dülmen, 48249
Study site
Düsseldorf, 40212
Study site
Friedrichshafen, 88045
Study site
Kiel, 24105
Study site
Mahlow, 15831
Study site
Mainz, 55131
Study site
Osnabrück, 49078
Study site
Schweinfurt, 97421
Study site
Selters, 56242
Study site
Stuttgart, 70178
Study site
Stuttgart, 70499
Study site
Ulm, 89081
About this study
Official title: A Randomized, Multicenter, Double-blind, Vehicle-controlled Study to Evaluate the Safety and Efficacy of Two Different Doses of a Topical Minocycline Foam Compared to Vehicle in the Treatment of Papulopustular Rosacea - Study FX2015-10
The purpose of this study is to see if the study drug, FMX-103, is safe to give and if it helps people with moderate-to-severe papulopustular rosacea.
The investigational product is FMX-103 minocycline foam. Two concentrations of the investigational product, 1.5% and 3%, will be studied along with vehicle. The foam will be applied once daily to the face for the 12-week treatment duration of the study.
Approximately 210 patients will participate in this study.
- Conditions
- Rosacea, Papulopustular Rosacea
- Being tested
- FMX-103 1.5%, FMX-103 3%, Vehicle foam (0%)
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FMX-103 1.5%Drug
Also called Minocycline foam 1.5%
The investigational product is FMX-103 minocycline foam. Two concentrations of the investigational product, 1.5% and 3%, will be studied compared to vehicle in patients with moderate-to-severe papulopustular rosacea. The foam will be applied once daily to the face for the 12-week treatment duration of the study.
FMX-103 3%Drug
Also called Minocycline foam 3%
The investigational product is FMX-103 minocycline foam. Two concentrations of the investigational product, 1.5% and 3%, will be studied compared to vehicle in patients with moderate-to-severe papulopustular rosacea. The foam will be applied once daily to the face for the 12-week treatment duration of the study.
Vehicle foam (0%)Drug
Also called Placebo
The investigational product is FMX-103 minocycline foam. Two concentrations of the investigational product, 1.5% and 3%, will be studied compared to vehicle in patients with moderate-to-severe papulopustular rosacea. The foam will be applied once daily to the face for the 12-week treatment duration of the study.
| Study group | Role | What they receive |
|---|---|---|
| FMX-103 1.5% | Experimental | The investigational product is FMX-103 minocycline foam. Two concentrations of the investigational product, 1.5% and 3%, will be studied along with vehicle. The foam will be applied once daily to the face for the 12-week treatment duration of the study. Receives: Drug: FMX-103 1.5% |
| FMX-103 3% | Experimental | The investigational product is FMX-103 minocycline foam. Two concentrations of the investigational product, 1.5% and 3%, will be studied along with vehicle. The foam will be applied once daily to the face for the 12-week treatment duration of the study. Receives: Drug: FMX-103 3% |
| Vehicle foam (0%) | Placebo comparator | The investigational product is FMX-103 minocycline foam. Two concentrations of the investigational product, 1.5% and 3%, will be studied along with vehicle. The foam will be applied once daily to the face for the 12-week treatment duration of the study. Receives: Drug: Vehicle foam (0%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
the absolute change in inflammatory lesion count at Week 12 compared to Baseline.
Measured: Baseline to Week 12
Secondary outcomes (3)
The dichotomized Investigator's Global Assessment (IGA) score at Week 12 compared to Baseline
Measured: Baseline to Week 12
Percent change in inflammatory lesion count at Week 12 compared to Baseline
Measured: Baseline to Week 12
The dichotomized modified Investigator's Global Assessment (mIGA) score at Week 12 compared to Baseline.
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2015 (estimated)
- Study startSep 2015
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 233 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vyne Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ulrich Mrowietz, MD, Principal investigator, University Hospital Schleswig-Holstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02601963
- Sponsor's protocol ID
- Study FX2015-10
- Acronym
- EMIRA
- Status last verified
- Feb 2017
- First submitted
- 19 Oct 2015
- Last updated
- 15 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Mrowietz U, Kedem TH, Keynan R, Eini M, Tamarkin D, Rom D, Shirvan M. A Phase II, Randomized, Double-Blind Clinical Study Evaluating the Safety, Tolerability, and Efficacy of a Topical Minocycline Foam, FMX103, for the Treatment of Facial Papulopustular Rosacea. Am J Clin Dermatol. 2018 Jun;19(3):427-436. doi: 10.1007/s40257-017-0339-0.
PubMed 29396702
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2017. 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 Two Different Doses of a Topical Minocycline Foam Compared to Vehicle in the Treatment of Papulopustular Rosacea - Study FX2015-10
- ClinicalTrials.gov ID
- NCT02601963
- Acronym / sponsor ID
- EMIRA / Study FX2015-10
- Conditions
- Rosacea, Papulopustular Rosacea
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 233 participants (actual)
- Lead sponsor
- Vyne Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 11 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to see if the study drug, FMX-103, is safe to give and if it helps people with moderate-to-severe papulopustular rosacea.
The investigational product is FMX-103 minocycline foam. Two concentrations of the investigational product, 1.5% and 3%, will be studied along with vehicle. The foam will be applied once daily to the face for the 12-week treatment duration of the study.
Approximately 210 patients will participate in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FMX-103 1.5% | Experimental | Drug: FMX-103 1.5%The investigational product is FMX-103 minocycline foam. Two concentrations of the investigational product, 1.5% and 3%, will be studied along with vehicle. The foam will be applied once daily to the face for the 12-week treatment duration of the study. |
| FMX-103 3% | Experimental | Drug: FMX-103 3%The investigational product is FMX-103 minocycline foam. Two concentrations of the investigational product, 1.5% and 3%, will be studied along with vehicle. The foam will be applied once daily to the face for the 12-week treatment duration of the study. |
| Vehicle foam (0%) | Placebo comparator | Drug: Vehicle foam (0%)The investigational product is FMX-103 minocycline foam. Two concentrations of the investigational product, 1.5% and 3%, will be studied along with vehicle. The foam will be applied once daily to the face for the 12-week treatment duration of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants age is 18 years or older.
- Participants have a moderate-to-severe rosacea excluding lesions involving the eyes and scalp.
- Subject must have diagnosed rosacea for at least 6 months prior to screening.
Key exclusion criteria (6 listed)
- History of hypersensitivity or allergy to minocycline, any other tetracycline or any other component of the formulation such as Soybean oil or Coconut oil.
- Women of child bearing potential who are pregnant, lactating (in the last 3 months) or planning to become pregnant during the study period.
- Moderate or severe rhinophyma, dense telangiectasis (score 3, severe), or plaque- like facial edema.
- Rosacea conglobata or fulminans, corticosteroid-induced rosacea or isolated pustulosis of the chin, facial erythrosis of known origin other than rosacea (e.g., known carcinoid syndrome).
- Ocular rosacea (e.g., conjunctivitis, blepharitis, or keratitis) of sufficient severity to require topical ophthalmic or systemic antibiotics, papulopustular rosacea that requires medically indicated systemic treatment.
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 |
|---|---|---|
| FMX-103 1.5%Also: Minocycline foam 1.5%The investigational product is FMX-103 minocycline foam. Two concentrations of the investigational product, 1.5% and 3%, will be studied compared to vehicle in patients with moderate-to-severe papulopustular rosacea. The foam will be applied once daily to the face for the 12-week treatment duration of the study. | Drug | FMX-103 1.5% |
| FMX-103 3%Also: Minocycline foam 3%The investigational product is FMX-103 minocycline foam. Two concentrations of the investigational product, 1.5% and 3%, will be studied compared to vehicle in patients with moderate-to-severe papulopustular rosacea. The foam will be applied once daily to the face for the 12-week treatment duration of the study. | Drug | FMX-103 3% |
| Vehicle foam (0%)Also: PlaceboThe investigational product is FMX-103 minocycline foam. Two concentrations of the investigational product, 1.5% and 3%, will be studied compared to vehicle in patients with moderate-to-severe papulopustular rosacea. The foam will be applied once daily to the face for the 12-week treatment duration of the study. | Drug | Vehicle foam (0%) |
Primary outcome
the absolute change in inflammatory lesion count at Week 12 compared to Baseline.
Time frame: Baseline to Week 12
3 secondary outcomes
The dichotomized Investigator's Global Assessment (IGA) score at Week 12 compared to Baseline
Time frame: Baseline to Week 12
Percent change in inflammatory lesion count at Week 12 compared to Baseline
Time frame: Baseline to Week 12
The dichotomized modified Investigator's Global Assessment (mIGA) score at Week 12 compared to Baseline.
Time frame: Baseline to Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2017.
- Derived from this study: PubMed 29396702Mrowietz U, Kedem TH, Keynan R, Eini M, Tamarkin D, Rom D, Shirvan M. A Phase II, Randomized, Double-Blind Clinical Study Evaluating the Safety, Tolerability, and Efficacy of a Topical Minocycline Foam, FMX103, for the Treatment of Facial Papulopustular Rosacea. Am J Clin Dermatol. 2018 Jun;19(3):427-436. doi: 10.1007/s40257-017-0339-0.
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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.
Ulrich Mrowietz, MD principal investigator
University Hospital Schleswig-Holstein
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FMX-103 1.5% and FMX-103 3% in people with Rosacea and Papulopustular Rosacea, run by Vyne Therapeutics Inc. at 20 sites in Germany.
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 3 inclusion and 6 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 15 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Germany. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 in inflammatory lesion count at Week 12 compared to Baseline. (time frame: Baseline to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02601963, which also lists 1 linked publication.
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 15 Feb 2017.