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EMIRA: Safety and Efficacy Study of a Topical Minocycline Foam in Patients With Papulopustular Rosacea

Sponsor
Vyne Therapeutics Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02601963
Collaborator
(none)
233
Enrollment
20
Locations
3
Arms
11
Duration (Months)
11.7
Patients Per Site
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: FMX-103 1.5%
  • Drug: FMX-103 3%
  • Drug: Vehicle foam (0%)
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
233 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Study Start Date :
Sep 1, 2015
Actual Primary Completion Date :
Aug 1, 2016
Actual Study Completion Date :
Aug 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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 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 Names:
  • Minocycline foam 1.5%

    		•
    Experimental: 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.

    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 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 Names:
  • Minocycline foam 3%

    		•
    Placebo Comparator: 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.

    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 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 Names:
  • Placebo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. the absolute change in inflammatory lesion count at Week 12 compared to Baseline. [Baseline to Week 12]

    Secondary Outcome Measures

    1. The dichotomized Investigator's Global Assessment (IGA) score at Week 12 compared to Baseline [Baseline to Week 12]

    2. Percent change in inflammatory lesion count at Week 12 compared to Baseline [Baseline to Week 12]

    3. The dichotomized modified Investigator's Global Assessment (mIGA) score at Week 12 compared to Baseline. [Baseline to Week 12]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Participants age is 18 years or older.

    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:

    1. History of hypersensitivity or allergy to minocycline, any other tetracycline or any other component of the formulation such as Soybean oil or Coconut oil.

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Berlin Germany 10783
    2 Berlin Germany 13055
    3 Berlin Germany 13086
    4 Berlin Germany 13507
    5 Blaubeuren Germany 89143
    6 Bochum Germany 44803
    7 Buxtehude Germany 21614
    8 Darmstadt Germany 64283
    9 Dülmen Germany 48249
    10 Düsseldorf Germany 40212
    11 Friedrichshafen Germany 88045
    12 Kiel Germany 24105
    13 Mahlow Germany 15831
    14 Mainz Germany 55131
    15 Osnabrück Germany 49078
    16 Schweinfurt Germany 97421
    17 Selters Germany 56242
    18 Stuttgart Germany 70178
    19 Stuttgart Germany 70499
    20 Ulm Germany 89081

    Sponsors and Collaborators

    • Vyne Therapeutics Inc.

    Investigators

    • Principal Investigator: Ulrich Mrowietz, MD, University Hospital Schleswig-Holstein

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Vyne Therapeutics Inc.
    ClinicalTrials.gov Identifier:
    NCT02601963
    Other Study ID Numbers:
    • Study FX2015-10
    First Posted:
    Nov 11, 2015
    Last Update Posted:
    Feb 15, 2017
    Last Verified:
    Feb 1, 2017
    Additional relevant MeSH terms:
    Rosacea
    Minocycline

    Study Results

    No Results Posted as of Feb 15, 2017