A Randomized, Double-Blind, Vehicle Controlled Study To Evaluate The Safety, Tolerability, And Efficacy Of DMT210 Gel In Adult Patients With Moderate To Severe Acne Rosacea
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 1
- 主要终点
- Efficacy as measured by Inflammatory lesion counts
研究概览
简要总结
The study evaluates the safety, tolerability, and efficacy of DMT210 Gel, 5% when applied twice daily for 12 weeks in adult patients with moderate to severe acne rosacea. Half of participants will receive DMT210 Gel while the other half will receive vehicle control.
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
- •Patient is male or non-pregnant female at least 18 years of age.
- •Clinical diagnosis of moderate to severe facial rosacea as determined by Investigator's Global Assessment (IGA) at Randomization
- •Patient has at least ten inflammatory lesions of rosacea on the face at Randomization
- •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 which may affect the patient's rosacea
研究组 & 干预措施
DMT210 Topical Gel
DMT210 Topical Gel 5% applied to the face twice daily for 12 weeks
干预措施: DMT210 Topical Gel 5% (Drug)
Vehicle Control
Topical Gel vehicle applied to the face twice daily for 12 weeks
干预措施: Vehicle Control (Other)
结局指标
主要结局
Efficacy as measured by Inflammatory lesion counts
时间窗: 12 weeks
Inflammatory lesion counts
Efficacy as measured by 5-point Clinical Erythema Assessment (CEA)
时间窗: 12 weeks
5-point Clinical Erythema Assessment (CEA)
Efficacy as measured by Investigator Global Assessment (IGA)
时间窗: 12 weeks
Investigator Global Assessment (IGA)
Efficacy as measured by 5-point Patient Severity Assessment of Erythema (PSA)
时间窗: 12 weeks
5-point Patient Severity Assessment of Erythema (PSA)
次要结局
- Incidence of adverse events as a measure of safety and tolerability(12 weeks)