NL-OMON48618已完成不适用
Early clinical and biomarker responses after treatment in patients with non-segmental vitiligo - Early responses in vitiligo
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Patients with non-segmental vitiligo commencing standard of care treatment,
- •consisting of a potent topical corticosteroid, such as FP cream, alone or in
- •combination with NB-UVB phototherapy for at least 6 months.
- •- Patients with new lesions and/or signs of disease progression (active
- •disease) within the past 6 months prior to Screening.
- •- Males and females aged *18
- •- Patients able to communicate well with the investigator, to understand the
- •requirements of the study, as well as understand and sign the written informed
排除标准
- •- Patients that have received phototherapy or systemic immunosuppressive
- •treatment during the last 6 weeks prior to Screening.
- •- Patients that have received topical anti-inflammatory treatment (topical
- •corticosteroids, calcineurin inhibitors) during the last 4 weeks prior to
- •- Patients currently receiving treatments other than potent topical
- •corticosteroids, such as FP 0.05% cream, calcineurin inhibitors (tacrolimus,
- •pimecrolimus) or NB-UVB phototherapy for non-segmental vitiligo.
- •- Recurrent HSV skin infections.
- •- Patients with a history of hypertrophic scars or keloid.
- •- Patients with a history of hypersensitivity to (UVB or UVA) light and/or
- •allergy to local anaesthesia.
- •- Pregnant or nursing (lactating) women, where pregnancy is defined as the
- •state of a female after conception and until the termination of gestation,
- •confirmed by a positive hCG laboratory test (unless female is confirmed
- •post-menopausal).
- •- Patients with haemophilia or other clotting disorders
- •- Patients previously diagnosed with depression according to the DSM5 by a
- •qualifying physician.
- •- Patients without lesions located at suitable areas for biopsies / suction
- •blisters sampling (e.g. the face)
研究者
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