NCT03315689已完成2 期
A Randomized, Double-blind, Vehicle-controlled Multicenter Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of ATI-50002 Topical Solution Administered Twice-Daily for 28 Days in Adult Subjects With Alopecia Universalis and Alopecia Totalis With a 12-Month Long-Term Open-Label Extension
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Double Blind Period: ATI-50002 Levels in Scalp Biopsy (ng/g) - Pharmacodynamic (PD) Population at Day 2 and Day 29
研究概览
简要总结
The primary objective is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of ATI-50002 Topical Solution compared to vehicle in subjects with AU and AT.
详细描述
This study is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ATI-50002 Topical Solution in patients with Alopecia Universalis and Alopecia Totalis. Concentrations of ATI-50002 in the blood and skin will be assessed after 28 days of treatment with ATI-50002 Topical Solution.
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
- Double (Participant, Investigator)
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
- •Able to comprehend and willing to sign an Informed Consent Form (ICF).
- •Male or non-pregnant, non-nursing female ≥18 years old at the time of informed consent.
- •Have a clinical diagnosis of stable, clinically typical, AU or AT.
- •Have a duration of the current episode of AU or AT for a minimum of 6 months and a maximum of seven years.
- •Be willing and able to follow all study instructions and to attend all study visits.
排除标准
- •Females who are nursing, pregnant, or planning to become pregnant for the duration of the study including 30 days after the last application of study medication.
- •Patchy alopecia areata, diffuse alopecia areata or a history of an atypical pattern of Alopecia Areata (AA) (e.g., ophiasis, sisaihpo).
- •Active skin disease on the scalp (such as psoriasis or seborrheic dermatitis) or a history of skin disease on the scalp that in the opinion of the investigator would interfere with the study assessments of efficacy or safety.
- •Active scalp trauma or other condition affecting the scalp that, in the investigator's opinion, may affect the course of AU or AT or interfere with the study conduct or evaluations.
- •The presence of a permanent or difficult to remove hairpiece or wig that will, in the opinion of the investigator, interfere with study assessments if not removed at each visit.
研究组 & 干预措施
Vehicle
Placebo Comparator
Vehicle
干预措施: Vehicle (Drug)
Active
Experimental
ATI-50002 Topical Solution
干预措施: ATI-50002 (Drug)
结局指标
主要结局
Double Blind Period: ATI-50002 Levels in Scalp Biopsy (ng/g) - Pharmacodynamic (PD) Population at Day 2 and Day 29
时间窗: Day 2 - Day 29
ATI-50002 levels in scalp biopsies taken at Visits 3 (Day 2) and 7 (Day 29).
次要结局
- Open Label Extension: Mean Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 52(Baseline - Week 52)
- Open Label Extension: Mean Change in Subject's Eyebrow Assessment (SEA) at Week 52(Week 4 - Week 52)
- Open Label Extension: Mean Change in Clinician's Eyebrow Assessment (CEA) at Week 28(Week 4 - Week 28)
- Open Label Extension: Mean Change in Clinician's Eyebrow Assessment (CEA) at Week 40(Week 4 - Week 40)
- Open Label Extension: Mean Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 40(Baseline - Week 40)
- Open Label Extension: Mean Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 28(Baseline - Week 28)
- Open Label Extension: Change From Baseline in Alopecia Density and Extent Score (ALODEX) at Week 28(Baseline - Week 28)
- Open Label Extension: Change From Baseline in Alopecia Density and Extent Score (ALODEX) at Week 40(Baseline - Week 40)
- Open Label Extension: Change From Baseline in Alopecia Density and Extent Score (ALODEX) at Week 52(Baseline - Week 52)
- Open Label Extension: Mean Change in Subject's Eyebrow Assessment (SEA) at Week 28(Week 4 - Week 28)
- Open Label Extension: Mean Change in Subject's Eyebrow Assessment (SEA) at Week 40(Week 4 - Week 40)
- Open Label Extension: Mean Change in Clinician's Eyebrow Assessment (CEA) at Week 52(Week 4 - Week 52)
- Open Label Extension: Subject Global Impression of Treatment Satisfaction (SGIS) Week 28(Week 28)
- Open Label Extension: Subject Global Impression of Treatment Satisfaction (SGIS) Week 40(Week 40)
- Open Label Extension: Subject Global Impression of Treatment Satisfaction (SGIS) Week 52(Week 52)
- Open Label Extension: Severity of Alopecia Tool (SALT) Scores, Relative Percent Regrowth (%) at Week 24 From Baseline(Baseline - Week 24)
- Open Label Extension: Severity of Alopecia Tool (SALT Scores), Relative Percent Regrowth (%) at Week 40 From Baseline(Baseline - Week 40)
- Open Label Extension: The Severity of Alopecia Tool (SALT) Scores, Relative Percent Regrowth (%) at Week 52 From Baseline(Baseline - Week 52)
- Open Label Extension: The Alopecia Density and Extent (ALODEX) Scores, Relative Percent Regrowth (%) at 24 Weeks(Baseline - Week 24)
- Open Label Extension: The Alopecia Density and Extent (ALODEX) Scores, Relative Percent Regrowth (%) at 40 Weeks(Baseline - Week 40)
- Open Label Extension: The Alopecia Density and Extent (ALODEX) Scores, Relative Percent Regrowth (%) at 52 Weeks(Baseline - Week 52)
研究者
研究点 (1)
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