EUCTR2017-002720-24-DK进行中（未招募）1 期
Efficacy of twice daily application of LEO 124249 ointment 30 mg/g for 12weeks on eyebrow alopecia areata. Exploratory Phase 2a - Efficacy of twice daily application of LEO 124249 ointment 30 mg/g for 12 weeks on eyebrow alopecia
EO Pharma A/S0 个研究点目标入组 24 人开始时间: 2017年8月22日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Signed and dated informed consent has been obtained before any trial related activities. Trial related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
- •2. Clinical unequivocal diagnosis of Alopecia Areata (patchy, univeralis and totalis, on both scalp and eyebrows as assessed by the investigator.
- •3. Maximal disease duration of current episode of Alopecia Areata on the eyebrows of 3 years at screening.
- •4. Maximal Alopecia Areata disease duration - defined as years of active disease - in other locations than eyebrows of 10 years at screening.
- •5. Male or female, age between 18 and 65 years at screening.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 24
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Clinical diagnosis of diffuse type alopecia areata as assessed by the investigator.
- •2. 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.
- •3. The following topical treatments are permitted elsewhere on the body: up to 25g per week of mild to moderate corticosteroids (WHO groups I-III), calcipotriol or calcineurin inhibitors for inflammatory skin conditions (e.g. atopic dermatitis or psoriasis).
- •4. 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.
- •5. The following inhaled medications are permitted: the equivalent to 1mg prednisolone used intranasaly or inhaled for rhinitis or asthma.
- •6. Systemic JAK inhibitor Ruxolitinib (Jakafi®/Jakavi®), Tofacitinib (Xeljanz®) at any time prior to randomisation.
- •7. Ongoing skin infection requiring systemic antimicrobials at randomisation.
- •8. Any skin condition, that in the opinion of the investigator, would interfere with the trial specified assessments.
- •9. Debute of thyroid disease or change in thyroid medication and/or dose within 6 months of screening.
- •10. Female subjects who are pregnant, breast feeding or intends to become pregnant or is of childbearing potential* and not using highly effective contraceptive methods** at trial entry and until end of follow-up visit.
- •*Female subjects are considered of child-bearing potential unless they have undergone hysterectomy, bilateral
- •salpingectomy or bilateral oophorectomy or have been post-menopausal for at least one year prior to screening.
- •** Highly effective contraception is defined as follows:
- •Sexual abstinence (when this is in line with the preferred and usual life style of the subject)
- •Vasectomized partner (given that the subject is monogamous)
- •Bilateral tubal occlusion
- •An intrauterine device (IUD)
- •Intrauterine hormone-releasing system (IUS)
- •Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition
- •of ovulation (oral, intravaginal, transdermal)
- •Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable,
- •implantable)
- •Surgical sterilised (vasectomy/bilateral tubectomy, hysterectomy and bilateral ovariectomy)
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