Efficacy of Twice Daily Applications of LEO 124249 Ointment 30mg/g for 12 Weeks to Subjects With Alopecia Areata
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in Severity of Alopecia Areata Tool (SALT) Score
研究概览
简要总结
This clinical trial attempts to investigate the efficacy and safety of LEO 124249 ointment in the treatment of alopecia areata and the molecular disease mechanism and biomarkers.
详细描述
The objectives of this clinical trial are to compare the efficacy of twice-daily topical LEO 124249 30 mg/g ointment with LEO 124249 ointment vehicle for 12 weeks in the treatment of hair loss in subjects with alopecia areata, to evaluate the safety of this treatment, to evaluate hair regrowth, to determine subject quality of life, and to explore disease mechanism and its biomarkers.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have signed and dated informed consent after receiving verbal and written information about the clinical trial.
- •Subjects with unequivocal clinical diagnosis of moderate to severe scalp alopecia areata (patch type, totalis, universalis), as determined by the (sub) investigator, affecting a minimum of 30% scalp area at Visit 1 (Screening) and Visit 2 (Day 1, baseline).
- •Minimum 6 month duration of hair loss at Visit 1 (Screening). No upper limit time limit.
- •Subject must accept to not cut hair in the treated scalp areas during the trial.
排除标准
- •Females who are pregnant or are breast feeding.
- •Current signs of spontaneous hair regrowth.
- •Diffuse type alopecia areata.
- •Co-existing moderate to severe androgenic alopecia (Norwood-Hamilton stage IV-VI and Ludwig stage II and III)
- •Subjects with changed or expected changes in medication for thyroid disease within 6 month before Visit 1 (screening) or during the trial.
- •Systemic treatment with immunosuppressive drugs (e.g. methotrexate, cyclosporine, azathioprine), chloroquin derivatives, corticosteroids, or any other systemic therapy that in the opinion of the investigator could affect hair regrowth, within 6 weeks prior to randomization (inhaled or intra-nasal steroids corresponding to up to 1 mg prednisone for asthma or rhinitis may be used).
研究组 & 干预措施
LEO 124249
LEO 124249 ointment 30 mg/g twice daily
干预措施: LEO 124249 (Drug)
Vehicle
LEO 124249 ointment vehicle twice daily
干预措施: Vehicle (Other)
结局指标
主要结局
Change in Severity of Alopecia Areata Tool (SALT) Score
时间窗: From baseline (Day 1) to Week 12 (Day 84)
The SALT score indicates the sum area of scalp with hair loss and ranges from 0 - 100 (min-max), with higher scores indicating more hair loss. A negative change in SALT score indicates lesser (improvement) hair loss while positive high scores indicate more (worsening) hair loss.
次要结局
- Summary of Absolute SALT Score(At baseline (Day 1), Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84))
- Summary of Change in SALT Score(From baseline (Day 1) to Week 4 (Day 28), Week 8 (Day 56), and Week 12 (Day 84))
- Hair Color(At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84))
- Global Assessment of Overall Hair Regrowth Compared to Baseline(At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84))
- Participant's Global Assessment of Hair Regrowth(At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84))
- Summary of Relative Change in SALT Score(From baseline (Day 1) to Week 4 (Day 28), Week 8 (Day 56), and Week 12 (Day 84))
- Percentage of Patients Who Achieve 50% Improvement in the SALT Score(At Week 12 (Day 84))
- Hair Length(At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84))
- Hair Growth Rate(At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84))
- Relative Hair Thickness(At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84))
- Hair Type(At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84))
- Subcategory and Total Score of the Alopecia Areata Quality of Life Questionnaire (AA-QLI)(At baseline (Day 1) and at Week 12 (Day 84))
- Treatment Satisfaction Questionnaire for Medication Score(At Week 12 (Day 84))