NCT03325296终止2 期
Efficacy of Twice Daily Application of LEO 124249 Ointment 30 mg/g for 12 Weeks on Eyebrow Alopecia Areata.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- LEO Pharma
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Change from baseline to week 12 of investigator evaluated overall area score (ASoverall L+R) of eyebrow hair growth.
研究概览
简要总结
This clinical trial attempts to investigate the efficacy of LEO 124249 ointment in the treatment of alopecia areata on the eyebrows.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical unequivocal diagnosis of Alopecia Areata (patchy, univeralis and totalis), on both scalp and eyebrows as assessed by the investigator.
- •Maximal disease duration of current episode of Alopecia Areata on the eyebrows of 3 years at screening.
- •Maximal Alopecia Areata disease duration - defined as years of active disease - in other locations than eyebrows of 10 years at screening.
排除标准
- •Clinical diagnosis of diffuse type alopecia areata as assessed by the investigator.
- •Any topical, intralesional therapy or procedure applied within 2 cm of the treatment area, within 4 weeks of randomisation, which in the opinion of the investigator, could interfere with the trial assessments. This includes, but is not limited to: corticosteroids, calcineurin inhibitors, calcipotriol, minoxidil, antimicrobials, prostaglandin analogs (e.g. bimatoprost), herbal extracts, topical immunotherapy with allergens or irritants and any laser or phototherapy, and eyebrow tattoo.
- •Any systemic treatment with immunosuppressive drugs (e.g. methotrexate, cyclosporine, azathioprine), chloroquin derivatives, corticosteroids (including intralesional treatment outside the trial treatment area), or any other systemic therapy that in the opinion of the investigator could affect hair regrowth, within 4 weeks prior to randomisation.
- •Any biologic medicinal product targeting the immune system within 5 half-lives and minimum 4 weeks prior to randomisation (e.g. anti-TNFα, anti-IL17, anti IL12/23, anti IL-4Rα targeting drugs).
- •Systemic JAK inhibitor Ruxolitinib (Jakafi®/Jakavi®), Tofacitinib (Xeljanz®) at any time prior to randomisation.
研究组 & 干预措施
LEO 124249 ointment 30 mg/g
Experimental
Ointment to be applied on the eyebrow twice daily.
干预措施: LEO 124249 (Drug)
LEO 124249 ointment vehicle
Placebo Comparator
Ointment to be applied on the eyebrow twice daily.
干预措施: Ointment vehicle (Other)
结局指标
主要结局
Change from baseline to week 12 of investigator evaluated overall area score (ASoverall L+R) of eyebrow hair growth.
时间窗: baseline to week 12
The percentage area of the identified left and right eyebrow area and left and right region of interest (ROI) covered by hair growth will be scored according to the following: 1-10 % - 1 11-20 % - 2 21-30 % - 3 31-40 % - 4 41-50 % - 5 51-60 % - 6 61-70 % - 7 71-80 % - 8 81-90 % - 9 91-100 % - 10
次要结局
- Treatment emergent AEs (including AEs relating to local tolerability)(baseline to week 12)
- Investigator evaluation of cosmetic outcome at Week 12 as assessed by Cosmetic outcome Score(baseline to Week 12)
- Degree of response in change from baseline to Week 12 for ASoverall L+R(baseline to Week 12)
研究者
研究点 (1)
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