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
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