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

Phase 2

Completed

• Conditions: Papulopustular Rosacea; Rosacea
• Interventions: Drug: Vehicle foam (0%); Drug: FMX-103 1.5%; Drug: FMX-103 3%

• Registration Number: NCT02601963
• Lead Sponsor: Vyne Therapeutics Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-10-19
• Study First Submitted QC: 2015-11-10
• Study First Posted: 2015-11-11
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-14
• Last Update Posted: 2017-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 233

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vehicle foam (0%)	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.
FMX-103 1.5%	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 3%	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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