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OpenTrials
Completed

NCT Number: NCT02601963

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

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.

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Key information

Conditions

Rosacea Papulopustular Rosacea Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Berlin, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FMX-103 1.5%

Drug

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%

FMX-103 3%

Drug

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%

Vehicle foam (0%)

Drug

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

Primary outcomes

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

    Time frame: Baseline to Week 12

Secondary outcomes

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

    Time frame: Baseline to Week 12

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

    Time frame: Baseline to Week 12

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

    Time frame: Baseline to Week 12

Sponsors and collaborators

Lead sponsor

Vyne Therapeutics Inc.

Industry

Registry information

Official study 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

Acronym: EMIRA

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 11, 2015
Registry last updated
Feb 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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