Papulopustular Rosacea, Rosacea
Conditions
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.
Interventions
DRUGFMX-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.
DRUGFMX-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.
DRUGVehicle 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.
Sponsors
Vyne Therapeutics Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the absolute change in inflammatory lesion count at Week 12 compared to Baseline. | Baseline to Week 12 |
Secondary
| Measure | Time frame |
|---|---|
| Percent change in inflammatory lesion count 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 |
| The dichotomized modified Investigator's Global Assessment (mIGA) score at Week 12 compared to Baseline. | Baseline to Week 12 |
Countries
Germany
Outcome results
None listed