A Randomized, Multicenter, Double-blind, Vehicle-controlled Study to Evaluate the Safety and Efficacy of FMX103 1.5% Topical Minocycline Foam Compared to Vehicle in the Treatment of Facial Papulopustular Rosacea (FX2016-11)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 751
- 试验地点
- 54
- 主要终点
- The Absolute Change From Day 0/Baseline in the Inflammatory Lesion Count at Week 12
研究概览
简要总结
The primary objectives of this study are to determine the efficacy and safety of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea.
详细描述
This is a randomized, multicenter, double-blind, vehicle-controlled, 2 arm study to evaluate the safety and efficacy of FMX103 topical foam containing 1.5% minocycline compared to vehicle, in the treatment of participants with moderate-to-severe facial papulopustular rosacea. Qualified participants will be randomized in a 2:1 ratio (active:vehicle) to receive 1 of the following 2 treatments:
- FMX103 minocycline foam 1.5%
- Vehicle foam
Participants will be assigned to 1 of 2 treatments according to the randomization schedule. Participants will apply (or have applied) the study drug topically once daily for 12 weeks as directed. Participants will be advised to use the study drug at approximately the same time each day. Both the Investigator and participant will be blinded to the study drug identity. Participants will return for visits at Weeks 1, 4, 6, 8, 10, and 12. Efficacy evaluations (inflammatory lesion counts and Investigator's Global Assessment [IGA] score) will be performed at Weeks 4, 8, and 12 during the study.
Note: Originally the two studies FX2016-11 and FX2016-12 were combinedly presented in the protocol registration form under one NCT number (NCT03142451), and later separated since results were analyzed separately.
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)
盲法说明
This is a double-blind study, with limited access to the randomization code. The randomization code will be held in confidence until after the study database is locked and a memo documenting the database lock has been issued. Every effort will be made to retain the integrity of the blind. When issued to the sites, the study drug will be identical in appearance for all participants, regardless of treatment assignment.
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
- •Moderate-to-severe rosacea (as per the IGA score) on the proposed facial treatment area consisting of:
- •At least 15 and not more than 75 facial papules and pustules, excluding lesions involving the eyes and scalp;
- •No more than 2 nodules on the face.
- •Presence of or history of erythema and/or flushing on the face.
排除标准
- •Presence of any skin condition and/or Excessive facial hair, on the face that would interfere with the diagnosis or assessment of rosacea.
- •Moderate or severe rhinophyma, dense telangiectasia (score 3, severe), or plaque-like facial edema.
- •History of hypersensitivity or allergy to minocycline, any other tetracycline, or of any other component of the formulation.
- •Active ocular rosacea (eg, conjunctivitis, blepharitis, or keratitis) of sufficient severity to require topical or systemic antibiotics.
研究组 & 干预措施
FMX103 1.5%
Participants will apply the assigned FMX103 minocycline foam 1.5% topically once daily for 12 weeks as directed.
干预措施: FMX103 minocycline foam 1.5% (Drug)
Vehicle foam
Participants will apply the assigned vehicle foam topically once daily for 12 weeks as directed.
干预措施: Vehicle foam (Drug)
结局指标
主要结局
The Absolute Change From Day 0/Baseline in the Inflammatory Lesion Count at Week 12
时间窗: Baseline and Week 12
To determine the efficacy of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea. Lesion counts included the number of papules, pustules, and nodules. Change from Baseline was calculated as the value at Baseline minus the post-Baseline value. Thus, a positive change reflects a reduction in lesion count.
Percentage of Participants Achieving Investigator Global Assessments (IGA) Treatment Success at Week 12
时间窗: Week 12
To determine the efficacy of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea. The Investigator assessed the global severity of rosacea using the IGA scale. The scale ranges from 0 (Clear): No inflammatory papules or pustules to 4 (Severe): Many inflammatory papules or pustules, and up to 2 nodules. Higher scores indicated severe outcome. Treatment success was defined as an IGA score of 0 (clear) or 1 (almost clear), and at least a 2-step improvement (decrease) from Day 0/Baseline.
次要结局
- Percentage of Participants Achieving IGA Treatment Success of at Least 2 Grades at Week 12(Week 12)
- The Percent Change From Day 0/Baseline in Inflammatory Lesion Count at Week 12(Baseline and Week 12)
- The Absolute Change From Day 0/Baseline in the Inflammatory Lesion Counts at Week 4 and Week 8(Baseline, Week 4 and Week 8)
- Percentage of Participants Achieving IGA Treatment Success at Week 4 and Week 8(Week 4 and Week 8)
- Number of Participants With Adverse Events (AEs)(From Day 0/Baseline until the Safety Follow-up (4 weeks after Week 12 [Final Visit]))