A Study Of The Tolerability, Safety, And Efficacy Of DMT310 For The Treatment Of Acne Rosacea
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Efficacy as measured by lesion counts
研究概览
简要总结
The objective is to evaluate the tolerability, safety, and efficacy of DMT310 topical powder mixed with diluent in male and female patients with moderate to severe facial acne rosacea.
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
- Quadruple (Participant, Care Provider, 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
- •Patient is male or non-pregnant female at least 18 years of age.
- •Clinical diagnosis of moderate to severe papulopustular acne rosacea as determined by:
- •Investigator's Global Assessment (IGA) at Randomization score of 3 or
- •Patient has at least 15 inflammatory lesions on the face
- •Patient is willing to apply the Investigational Product as directed
- •Patient is willing and able to comply with the protocol
排除标准
- •Patient is pregnant or planning to become pregnant Patient is taking a topical therapy on the face which may affect the patient's rosacea
研究组 & 干预措施
Study Treatment 1
DMT310 Powder mixed with Hydrogen Peroxide
干预措施: Topical Powder (Drug)
Study Treatment 2
Placebo powder mixed with Hydrogen Peroxide
干预措施: Placebo Topical Powder (Drug)
结局指标
主要结局
Efficacy as measured by lesion counts
时间窗: 12 Weeks
Inflammatory lesion counts
Efficacy as measured by Investigator Global Assessment (IGA)
时间窗: 12 Weeks
IGA Scale: 0 Clear No papules and/or pustules 1. Almost Clear Rare papules and/or pustules 2. Mild Few papules and/or pustules 3. Moderate Pronounced number of papules and/or pustules (but less than numerous papules and/or pustules) 4. Severe Numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions
次要结局
- Incidence of adverse events as a measure of safety and tolerability(12 Weeks)