A Study of Tolerability, Safety, And Efficacy, of DMT310 In Patients With Acne Vulgaris
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 121
- 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 vulgaris.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, 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 acne vulgaris as determined by:
- •Investigator's Global Assessment (IGA) at Randomization Patient has at least 20 but not more than 50 inflammatory lesions on the face Patient has at least 20 but not more than 100 noninflammatory 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 acne
研究组 & 干预措施
Study Treatment 1
DMT310 Powder mixed with Hydrogen Peroxide
干预措施: DMT310 (Drug)
Study Treatment 1
DMT310 Powder mixed with Hydrogen Peroxide
干预措施: Hydrogen Peroxide (Drug)
Study Treatment 2
DMT310 Powder mixed with Placebo Diluent
干预措施: DMT310 (Drug)
Study Treatment 3
Placebo powder mixed with Hydrogen Peroxide
干预措施: Hydrogen Peroxide (Drug)
Study Treatment 3
Placebo powder mixed with Hydrogen Peroxide
干预措施: Placebo (Drug)
Control
Placebo powder mixed with Placebo Diluent
干预措施: Placebo (Drug)
结局指标
主要结局
Efficacy as measured by lesion counts
时间窗: 12 weeks
Inflammatory and Noninflammatory
Efficacy as measured by Investigator Global Assessment (IGA)
时间窗: 12 weeks
0 None No evidence of facial acne vulgaris 1. Minimal Few noninflammatory lesions (comedones) are present; a few inflammatory lesions(papules/pustules) may be present; no nodulo-cystic lesions are allowed) 2. Mild Several to many noninflammatory lesions (comedones) are present; a few inflammatory lesions (papules/pustules) are present; no nodulo-cystic lesions are allowed 3. Moderate Many noninflammatory (comedones) and inflammatory lesions (papules/pustules) are present; no nodulo-cystic lesions are allowed 4. Severe Significant degree of inflammatory disease; papules/pustules are a predominant feature; a few nodulo-cystic lesions may be present; comedones may be present
次要结局
- Incidence of adverse events as a measure of safety and tolerability(12 weeks)