Double-blind, Vehicle-controlled, Randomised, Multi-centre Study to Evaluate the Efficacy and Safety of LH-8 Cutaneous Solution in Children and Adolescents With Moderate to Severe Scalp Alopecia Areata.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 107
- 试验地点
- 3
- 主要终点
- Relative change in scalp alopecia areata severity scores (SALT) from baseline value to be assessed after 24 weeks of treatment.
研究概览
简要总结
Double-blind, randomised, multi-centre study to evaluate the efficacy and safety of LH-8 cutaneous solution versus placebo in children and adolescents with moderate to severe scalp alopecia areata.
Phase 2/3 study performed in France, Germany, Bulgaria and India in 100 patients.
详细描述
Methods / trial design:
Randomised, double-blind, vehicle-controlled multicentre trial in parallel groups.
At screening (Visit 0), subjects will discontinue their previous treatment for alopecia areata, if any. Screening period will last up to 28 days. The 24-week treatment phase will include assessment Visits 1 to 3, which will take place at 12-week intervals. At assessment Visit 1, eligible subjects will be randomly assigned in a 2:1 ratio to receive LH-8 cutaneous solution or vehicle (placebo) twice daily for a 24 week treatment period. During the treatment phase the subjects will complete daily their drug diaries. The post-treatment safety and efficacy follow-up phase will include Visit 4 and Visit 5, 12 and 24 weeks after end of treatment, respectively.
Subjects (as applicable) and parents will be instructed to contact the investigator, if an event on scalp (intolerance) occurs during the treatment or post-treatment period. They may be asked to come to the site for an unscheduled visit, in order to perform additional examinations.
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
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
LH-8 cutaneous solution
LH-8 cutaneous solution (0.126 mL per spray) applied to the whole scalp:
干预措施: LH-8 (Drug)
Placebo cutaneous solution
Placebo cutaneous solution (0.126 mL per spray) applied to the whole scalp:
干预措施: Placebo (Drug)
结局指标
主要结局
Relative change in scalp alopecia areata severity scores (SALT) from baseline value to be assessed after 24 weeks of treatment.
时间窗: 24 weeks treatment
Visual assessment and global standardised scalp photographs for SALT evaluation.
次要结局
- Absolute change in SALT score from baseline at the end of 24 weeks' treatment period.(24 weeks treatment)
- Proportion of the responders, i.e. subjects achieving at least a 40% relative reduction in SALT score from baseline at the end of 24 weeks' treatment period.(24 weeks treatment)
- Adverse events(48 weeks)
- Visual assessment and global standardised scalp photographs for SALT evaluation.(After 12 and 24 weeks treatment)
- Change in percentage of subjects from baseline by the severity banding CDLQI scores.(48 weeks)
- Percentages of subjects by EuroQol Five Dimensions Youth Questionnaire (EQ-5D-Y) dimensions and levels at Visits 1-5.(48 weeks)
- General physical examination findings, including irritation of eyes and skin(24 weeks treatment)
- Assessment of treatment effect on hair follicles in non-alopecic areas by quantifying the number of new alopecic areas.(24 weeks treatment)
- Absolute and relative change of the EQ-Visual Analogue Scale (EQ-VAS) scores from baseline(48 weeks)
- Evaluation of the Paediatric Alopecia Areata Patient Benefit Index (PAAPBI) scores at Visits 1 to 5.(48 weeks)
- Assessment of the rate of spontaneous hair regrowth.(For 6-12 months)
- • Absolute and relative change from baseline in Children's Dermatology Life Quality Index (CDLQI) scores.(48 weeks)