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

Primary Purpose

Rosacea, Papulopustular Rosacea

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
FMX-103 1.5%
FMX-103 3%
Vehicle foam (0%)
Sponsored by
Vyne Therapeutics Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rosacea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

FMX-103 1.5%

FMX-103 3%

Vehicle foam (0%)

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

The dichotomized Investigator's Global Assessment (IGA) score at Week 12 compared to Baseline
Percent change in inflammatory lesion count at Week 12 compared to Baseline
The dichotomized modified Investigator's Global Assessment (mIGA) score at Week 12 compared to Baseline.

Full Information

First Posted
October 19, 2015
Last Updated
February 14, 2017
Sponsor
Vyne Therapeutics Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02601963
Brief Title
Safety and Efficacy Study of a Topical Minocycline Foam in Patients With Papulopustular Rosacea
Acronym
EMIRA
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 Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vyne Therapeutics Inc.

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rosacea, Papulopustular Rosacea

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
233 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FMX-103 1.5%
Arm Type
Experimental
Arm Description
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.
Arm Title
FMX-103 3%
Arm Type
Experimental
Arm Description
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.
Arm Title
Vehicle foam (0%)
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
FMX-103 1.5%
Other Intervention Name(s)
Minocycline foam 1.5%
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
FMX-103 3%
Other Intervention Name(s)
Minocycline foam 3%
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Vehicle foam (0%)
Other Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
the absolute change in inflammatory lesion count at Week 12 compared to Baseline.
Time Frame
Baseline to Week 12
Secondary Outcome Measure Information:
Title
The dichotomized Investigator's Global Assessment (IGA) score at Week 12 compared to Baseline
Time Frame
Baseline to Week 12
Title
Percent change in inflammatory lesion count at Week 12 compared to Baseline
Time Frame
Baseline to Week 12
Title
The dichotomized modified Investigator's Global Assessment (mIGA) score at Week 12 compared to Baseline.
Time Frame
Baseline to Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulrich Mrowietz, MD
Organizational Affiliation
University Hospital Schleswig-Holstein
Official's Role
Principal Investigator
Facility Information:
City
Berlin
ZIP/Postal Code
10783
Country
Germany
City
Berlin
ZIP/Postal Code
13055
Country
Germany
City
Berlin
ZIP/Postal Code
13086
Country
Germany
City
Berlin
ZIP/Postal Code
13507
Country
Germany
City
Blaubeuren
ZIP/Postal Code
89143
Country
Germany
City
Bochum
ZIP/Postal Code
44803
Country
Germany
City
Buxtehude
ZIP/Postal Code
21614
Country
Germany
City
Darmstadt
ZIP/Postal Code
64283
Country
Germany
City
Dülmen
ZIP/Postal Code
48249
Country
Germany
City
Düsseldorf
ZIP/Postal Code
40212
Country
Germany
City
Friedrichshafen
ZIP/Postal Code
88045
Country
Germany
City
Kiel
ZIP/Postal Code
24105
Country
Germany
City
Mahlow
ZIP/Postal Code
15831
Country
Germany
City
Mainz
ZIP/Postal Code
55131
Country
Germany
City
Osnabrück
ZIP/Postal Code
49078
Country
Germany
City
Schweinfurt
ZIP/Postal Code
97421
Country
Germany
City
Selters
ZIP/Postal Code
56242
Country
Germany
City
Stuttgart
ZIP/Postal Code
70178
Country
Germany
City
Stuttgart
ZIP/Postal Code
70499
Country
Germany
City
Ulm
ZIP/Postal Code
89081
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
29396702
Citation
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.
Results Reference
derived

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

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