NCT03445650已完成3 期
A Phase 3 Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Trial to Evaluate the Safety and Efficacy of ADX-102 1% Topical Dermal Cream (Reproxalap) in Subjects With Sjögren-Larsson Syndrome (SLS)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Visual Index Ichthyosis Severity (VIIS) Scaling Score as Assessed by the Investigator in ADX-102 Treated Patients
研究概览
简要总结
A Phase 3 Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Trial to Evaluate the Safety and Efficacy of ADX-102 1% Topical Dermal Cream in Subjects with Sjögren-Larsson Syndrome (SLS).
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
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is aged 3 years or older
- •Subject has a genetically-confirmed diagnosis of SLS.
- •Subject has active ichthyosis that is Grade 2 or higher on the Visual Index Ichthyosis Severity (VIIS) score.
- •Females of child-bearing potential: Negative pregnancy test at Screening and Baseline Visits.
排除标准
- •Subject has evidence of a serious active infection.
- •Systemic or topical retinoids or other topical medications, not including emollients, within the past 30 days Baseline Visit
- •Subject has received an investigational systemic or topically administered drug within the past 30 days prior to Baseline Visit
- •Subject is currently receiving immunosuppressive therapy, including intermittent or low-dose systemic corticosteroids.
- •Subject has a known allergic reaction to any ingredients of study drug formulation.
- •Subject has any clinically significant laboratory test abnormalities or a history of any other condition that, in the opinion of the Investigator, could compromise the subject's ability to comply with the protocol or that could compromise the subject's safety or the interpretation of the study results.
研究组 & 干预措施
ADX-102 1% Topical Dermal Cream (reproxalap)
Experimental
干预措施: ADX-102 1% Topical Dermal Cream (reproxalap) (Drug)
Vehicle of ADX-102 Topical Dermal Cream
Placebo Comparator
干预措施: Vehicle of ADX-102 Topical Dermal Cream (Drug)
结局指标
主要结局
Visual Index Ichthyosis Severity (VIIS) Scaling Score as Assessed by the Investigator in ADX-102 Treated Patients
时间窗: Efficacy assessment period (Week 1 through Week 24), where Baseline is Day 1.
Change from baseline using the Visual Index Ichthyosis Severity (VIIS) Scaling Score (0 = least, 4 = most), where a higher value represents a worse outcome, in ADX-102 treated patients
次要结局
未报告次要终点
研究者
研究点 (2)
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