Safety and Efficacy Study of a Topical Minocycline Foam in Patients With Papulopustular Rosacea
NCT ID: NCT02601963
Last Updated: 2017-02-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
233 participants
INTERVENTIONAL
2015-09-30
2016-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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 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%
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%
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%)
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%)
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.
Interventions
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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 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%
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%)
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Participants have a moderate-to-severe rosacea excluding lesions involving the eyes and scalp.
3. Subject must have diagnosed rosacea for at least 6 months prior to screening.
Exclusion Criteria
2. Women of child bearing potential who are pregnant, lactating (in the last 3 months) or planning to become pregnant during the study period.
3. Moderate or severe rhinophyma, dense telangiectasis (score 3, severe), or plaque- like facial edema.
4. 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).
5. 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.
6. Bacterial folliculitis.
18 Years
ALL
No
Sponsors
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Vyne Therapeutics Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Ulrich Mrowietz, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Schleswig-Holstein
Locations
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Berlin, , Germany
Berlin, , Germany
Berlin, , Germany
Berlin, , Germany
Blaubeuren Abbey, , Germany
Bochum, , Germany
Buxtehude, , Germany
Darmstadt, , Germany
Dülmen, , Germany
Düsseldorf, , Germany
Friedrichshafen, , Germany
Kiel, , Germany
Mahlow, , Germany
Mainz, , Germany
Osnabrück, , Germany
Schweinfurt, , Germany
Selters, , Germany
Stuttgart, , Germany
Stuttgart, , Germany
Ulm, , Germany
Countries
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References
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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.
Other Identifiers
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Study FX2015-10
Identifier Type: -
Identifier Source: org_study_id
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