A Randomized, Double-blind, Vehicle Controlled Study of the Safety and Efficacy of Topical DRM02 in Subjects With Rosacea
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Change in inflammatory lesion count
研究概览
简要总结
The purpose of this study is to determine whether DRM02 is safe and effective in the treatment of rosacea when applied twice daily for 6 weeks.
详细描述
This is a double-blind, randomized, vehicle controlled, study enrolling 30 subjects with rosacea and designed to assess the safety, tolerability, and preliminary efficacy of DRM02.
Safety will be assessed during the study, through adverse events, local skin responses, urinalysis, serum chemistry and hematology laboratory testing, physical examination and vital signs.
Preliminary efficacy will be assessed through inflammatory lesion counts, the Investigator's Global Evaluation (IGE) and the Rosacea Signs and Symptoms (RSS) scale.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female 18 to 70 years of age.
- •Clinical diagnosis of rosacea with a score of 2 or 3 on the Investigator's Global Evaluation (IGE) of Rosacea scale and at least 15 and not more than 40 papules.
- •Subjects willing to minimize external factors that might trigger rosacea flare-ups.
- •Male or non-pregnant, non-lactating females.
- •Signed informed consent.
排除标准
- •Severe self-reported facial sensitivity.
- •Severe sun sensitivity.
- •Ocular-only, phymatous rosacea or steroid rosacea.
- •Use of topical rosacea treatments in the 4 weeks prior to baseline.
- •Use of systemic corticosteroids within the 4 weeks prior to baseline.
- •Use of systemic antibiotics in the 4 weeks prior to baseline.
- •Use of systemic retinoids for in the 6 months prior to baseline.
- •Use of topical retinoids in the 3 months prior to baseline.
- •Use of light- or laser-based rosacea treatments in the past 2 months prior to baseline.
- •Cosmetic procedures within the 2 months prior to baseline.
- •Use of topical anti-aging medications in the 2 weeks prior to baseline.
- •Subjects who have poor skin condition within 5 cm of the treatment area.
- •Subjects who are current drug or alcohol abusers; have a history of immunodeficiency or are a poor medical risk because of other systemic diseases or active uncontrolled infections.
- •Subjects with an unstable medical condition or a medical condition not adequately controlled with standard medical therapy.
- •Subjects who are actively participating in an experimental therapy study or who have received experimental therapy within 30 days.
- •Subjects who have a clinically significant laboratory value at screening.
研究组 & 干预措施
DRM02
DRM02 Topical Gel, 0.25%
干预措施: DRM02 (Drug)
Vehicle
DRM02 Topical Gel, Vehicle
干预措施: Vehicle (Other)
结局指标
主要结局
Change in inflammatory lesion count
时间窗: Week 6
次要结局
- Percent change in inflammatory lesions(Week 6)
- Investigator's Global Evaluation (IGE)(From baseline to weeks 0, 1, 2, 3, 4 and 6)
- IGE dichotomized into "success" and "failure"(Week 6)