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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 233
- 主要终点
- the absolute change in inflammatory lesion count at Week 12 compared to Baseline.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: FMX-103 1.5% (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 along with vehicle. The foam will be applied once daily to the face for the 12-week treatment duration of the study.
干预措施: FMX-103 3% (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 along with vehicle. The foam will be applied once daily to the face for the 12-week treatment duration of the study.
干预措施: Vehicle foam (0%) (Drug)
结局指标
主要结局
the absolute change in inflammatory lesion count at Week 12 compared to Baseline.
时间窗: Baseline to Week 12
次要结局
- 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)
- Percent change in inflammatory lesion count at Week 12 compared to Baseline(Baseline to Week 12)