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临床试验/EUCTR2014-003473-42-GB
EUCTR2014-003473-42-GB进行中(未招募)1 期

Home Interventions and Light therapy for the treatment of vitiligo - HI-Light Vitiligo Trial

niversity of Nottingham0 个研究点目标入组 517 人开始时间: 2015年3月27日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
517

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. Patients 5 years of age or over with a diagnosis of non-segmental vitiligo confirmed by a dermatologist
  • 2. Vitiligo limited to less than 10% of body surface area, with at least one patch that is reported by the participant to have been active (new onset or spread) in the last 12 months.
  • 3. No other active therapy for vitiligo (or willing to stop current treatment – no washout period required).
  • 4. Able to administer the intervention safely at home
  • 5. Able and willing to give informed consent (or parental/guardian consent in the case of children).
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range: 80
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 350
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 10

排除标准

  • 1. Other types of vitiligo (e.g. segmental or universal vitiligo).
  • 2. Patients with vitiligo limited to areas of the body for which NB-UVB light therapy or potent topical corticosteroids would be inappropriate (e.g. around the genitals).
  • 3. History of skin cancer (ever).
  • 4. History of radiotherapy use (ever).
  • 5. Photosensitivity (e.g. lupus, polymorphic light eruption, solar urticaria, chronic actinic dermatitis, actinic prurigo, porphyria or other photosensitivity disorders e.g. dermatomyositis)
  • 6. Pregnant, breastfeeding or likely to become pregnant during the 9-month treatment period.
  • 7. Current use of immunosuppressive drugs (e.g. e.g. ciclosporin, azathioprine, mycophenolate mofetil, methotrexate, systemic tacrolimus)
  • 8. Allergy or contraindication to mometasone furoate or any of its components (e.g any cutaneous bacterial, viral or fungal infections in the area to be exposed to trial treatments).
  • 9. Current participation in another clinical trial or intervention study

研究者

发起方
niversity of Nottingham

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