A Randomized, Double-blind, Vehicle Controlled Study of the Safety and Efficacy of Topical DRM02 in Subjects With Atopic Dermatitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Change in Physician's Lesion Assessment
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 atopic dermatitis when applied twice daily for 6 weeks.
详细描述
This is a double-blind, randomized, within-subject control, study enrolling 20 subjects with atopic dermatitis 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 the Physician's Lesion Assessment (PLA) and the Eczema Area and Severity Index (EASI) from only the two lesions identified at the baseline visit.
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 stable atopic dermatitis (AD) and with two lesions of similar size and have an identical score of at least 5 but no more than 9 on the sum of the individual components of the Eczema Area and Severity Index (EASI) at the Target Lesion scale.
- •Male or non-pregnant, non-lactating females.
- •Signed informed consent.
排除标准
- •Subjects who have unstable atopic dermatitis (AD).
- •Significant infection at the target lesion site.
- •Prior or concomitant use of systemic therapies for AD within the past 4 weeks. - Prior or concomitant use of topical treatments for AD, to within 10 cm of the target lesion within the past 4 weeks.
- •Prior or concomitant use of oral retinoids for AD within the last 6 months.
- •Use of biologics for AD within the past 3 months, or 5 half-lives (whichever is longer).
- •Subjects who have poor skin condition within 5 cm of the target lesion.
- •Subjects who are current drug or alcohol abusers; have a history of immunodeficiency disease; 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 Physician's Lesion Assessment
时间窗: Week 6
次要结局
- Physician's Lesion Assessment analyzed for treatment effect(From baseline to weeks 1, 2, 3, 4 and 6)