Pilot, Randomized, Double Blind, Placebo Controlled, Parallel Group, Dose Range Finding Study, to Evaluate the Tolerability and Safety of FXFM244 Antibiotic Foam and to Monitor Its Clinical Effect in Moderate to Severe Rosacea Patients
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Improvement in signs and symptoms of rosacea
研究概览
简要总结
Acne rosacea is a chronic acneiform disorder affecting both the skin and the eye. It is a syndrome of undetermined etiology characterized by both vascular and papulopustular components involving the face and occasionally the neck and upper trunk.
This is a pilot phase II study to evaluate the tolerability and safety and to monitor the clinical efficacy of Topical Minocycline Foam FXFM244 in moderate to severe Rosacea patients.
详细描述
A Pilot, Randomized, Double Blind, Placebo Controlled, Parallel Group, Dose Range Finding Study. The study will involve three treatment groups. Eligible patients will be randomized to receive either FXFM244 - 1%, FXFM244 - 4% or Placebo, in a blinded fashion. Patients will be treated twice daily for 12 weeks. Following the screening period and baseline visit, study subjects will return at Weeks 3, 6, 9 and 12. A follow up visit will take place at week 16. At each visit, patients will be evaluated via lesion count, global assessment tolerability and safety.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Patients with clinical diagnosis of moderate to severe facial rosacea as determined by:
- •At least 8 but no more than 50 total papules and/or pustules (inflammatory lesions)
- •Presence of moderate to severe erythema
- •Presence of telangiectasia.
- •An Overall Rosacea Severity score ≥2.5
- •Patient is male or female over 18 years of age.
- •No known medical conditions that, in the Investigator's opinion could interfere with study participation
- •Patient is willing and able to comply with all requirement of the protocol
- •Patient is willing and able to give written informed consent prior to participation in the study
排除标准
- •Presence of skin diseases at or near the investigational area
- •Immunosuppressed state or other serious systemic disease
- •Signs and/or symptoms of systemic infection
- •Concomitant medication:
- •Use of oral and/or topical antibiotic treatment within 14 days prior to study entry.
- •Use of any topical anti-rosacea agent except antibiotics within 14 days prior to study entry.
- •Use of cyproterone acetate, CPA-containing contraceptives (e.g. Diane) or other corticosteroids (during the last 3 months);
- •Use of retinoids (during the last 4 weeks)
- •Use of artificial sun bath or having a sun holiday during the last 2 weeks
- •Alcohol or drug abuse, according to assessment by the investigator
- •Known or suspected hypersensitivity to Minocycline or any of the excipients in the Study Medication
- •Use of another investigational drug within 30 days prior to entry into this study
- •Pregnant or lactating women.
研究组 & 干预措施
Topical Minocycline Foam FXFM244 Placebo
Minocycline Foam FXFM244 Placebo
干预措施: Topical Minocycline Foam FXFM244 (Drug)
Topical Minocycline Foam FXFM244, 1%
Minocycline Foam FXFM244, 1%
干预措施: Topical Minocycline Foam FXFM244 (Drug)
Topical Minocycline Foam FXFM244, 4%
Minocycline Foam FXFM244, 4%
干预措施: Topical Minocycline Foam FXFM244 (Drug)
结局指标
主要结局
Improvement in signs and symptoms of rosacea
时间窗: 12 weeks
次要结局
- The severity of the overall rosacea condition will be measured at baseline and at all follow-up visits. The severity will be assessed and graded based on the scales for erythema, telangiectases and number of papulopustular lesions(0, 3, 6, 9 and 12 weeks)