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

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.

Study Overview

• Status: Completed
• Conditions: Rosacea; Papulopustular Rosacea
• Intervention / Treatment: Drug: FMX-103 1.5%; Drug: FMX-103 3%; Drug: Vehicle foam (0%)

• Study Type: Interventional
• Enrollment (Actual): 233
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13086
  • Berlin, Germany, 13055
  • Berlin, Germany, 10783
  • Berlin, Germany, 13507
  • Blaubeuren, Germany, 89143
  • Bochum, Germany, 44803
  • Buxtehude, Germany, 21614
  • Darmstadt, Germany, 64283
  • Dülmen, Germany, 48249
  • Düsseldorf, Germany, 40212
  • Friedrichshafen, Germany, 88045
  • Kiel, Germany, 24105
  • Mahlow, Germany, 15831
  • Mainz, Germany, 55131
  • Osnabrück, Germany, 49078
  • Schweinfurt, Germany, 97421
  • Selters, Germany, 56242
  • Stuttgart, Germany, 70178
  • Stuttgart, Germany, 70499
  • Ulm, Germany, 89081

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the absolute change in inflammatory lesion count at Week 12 compared to Baseline.	Baseline to Week 12

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Vyne Therapeutics Inc.
• Investigators: Principal Investigator: Ulrich Mrowietz, MD, University Hospital Schleswig-Holstein

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: October 19, 2015
• First Submitted That Met QC Criteria: November 10, 2015
• First Posted (Estimate): November 11, 2015

Study Record Updates

• Last Update Posted (Actual): February 15, 2017
• Last Update Submitted That Met QC Criteria: February 14, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Rosacea; Anti-Infective Agents; Anti-Bacterial Agents; Minocycline
• Other Study ID Numbers: Study FX2015-10