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Brief Summary:
Vitiligo is a common acquired disorder of pigmentation affecting 0.5% to 1% of the world population. Sharply demarcated patches of depigmentation, which can affect all ethnicities, and can lead to cosmetic disfiguration and psychosocial distress, characterize the disease. The etiology of vitiligo remains unknown. Various mechanisms have been proposed, such as autoimmunity, self-destruction, biochemical, genetic, neural, oxidative stress, and an imbalance of epidermal cytokines leading to inflammation and selective loss of epidermal melanocytes. Currently, the most popular theory is autoimmunity. Previous studies noted that around 25-30% of patients have at least one other autoimmune disease, such as autoimmune thyroid disease, Addison's disease, pernicious anemia, and alopecia areata. Currently, NB-UVB phototherapy is the most widely used therapeutic option for vitiligo affecting more than 10-20% of the skin surface, as it is generally c**idered to be a safe initial treatment. Potential side effects include phototoxic reaction, thickening of the skin and koebnerization. NB-UVB is a band of UV radiation with a wavelength of 311-313 nm. UVB induces mitogenesis and migration in melanocytes mediated by several factors such as IL-1, TNF alpha, and leukotriene C4. UV radiation produces increased number and activity of melanocytes, increased melanin density, elongation and branching of dendrites, with increased transfer of more heavily melanized melanosomes to keratinocytes, seen clinically as increased pigmentation. Apremilast is an oral small molecule phosphodiesterase-4 (PDE4) inhibitor that has been shown to regulate inflammatory mediators. Apremilast enters cells by passive diffusion and, once intracellular, binds PDE4. PDE-4, the dominant phosphodiesterase expressed in immune cells, degrades cyclic AMP (cAMP) into AMP. PDE4 inhibition thereby elevates intracellular cAMP, which can down-regulate the inflammatory resp**es such as TNF-α, IFN-γ, interleukins (IL) 2, 12 and 23 through mechanisms such as partially inhibiting expression of inflammatory cytokines and increasing expression of anti-inflammatory mediators such as IL2 and IL10. The hypothesis is that apremilast will shut down the inflammatory insult in vitiligo and NB-UVB phototherapy will then be able to regenerate melanocytes and their activity. By examination of skin biopsies taken pre- and post-therapy, the study team aims to assess changes in immune and cellular markers in affected skin.
简短的总结:
白癜风是一种常见的色素沉着障碍，影响世界0.5%至1%的人口。这种病的特征是有明显的脱色斑块，这些斑块会影响到所有种族，并会导致美观的毁容和心理上的痛苦。白癜风的病因尚不清楚。各种机制已经被提出，如自身免疫、自我破坏、生化、遗传、神经、氧化应激和表皮细胞因子失衡导致炎症和表皮黑素细胞选择性丧失。目前，最流行的理论是自体免疫。先前的研究指出，大约25-30%的患者至少有一种自身免疫性疾病，如自身免疫性甲状腺疾病、艾迪生氏病、恶性贫血和斑秃。目前，NB-UVB光疗是白癜风最广泛使用的治疗方案，影响皮肤10-20%以上，一般认为是一种安全的初始治疗方法。潜在的副作用包括光毒性反应、皮肤增厚和生物合成。NB-UVB是一种波长为311-313 nm的紫外辐射带。UVB诱导黑素细胞在IL-1、TNF -、白三烯C4等多种因素介导下的有丝分裂和迁移。紫外线辐射增加了黑素细胞的数量和活性，增加了黑素密度、延长和树突状细胞的分枝，增加了黑素体向角化细胞的转移，临床上被认为是增加了色素沉着。Apremilast是一种口服小分子磷酸二酯酶-4 (PDE4)抑制剂，已被证明可以调节炎症介质。Apremilast通过被动扩散进入细胞，一旦细胞内结合PDE4。PDE-4,占据主导地位的磷酸二酯酶免疫细胞中表达,降低环腺苷酸(cAMP)AMP。PDE4抑制从而提高细胞内营,可以抑制炎症反应,如TNF-αIFN-γ,白细胞介素(IL)2、12和23日通过部分抑制炎性细胞因子的表达等机制,增加IL2和IL10等抗炎介质的表达。假设apremilast能够抑制白癜风的炎性损伤，NB-UVB光疗将能够再生黑素细胞及其活性。通过检查治疗前后的皮肤活检，研究小组的目标是评估受影响皮肤中免疫和细胞标志物的变化。
Study Type : Interventional (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Enrolled subjects will be randomized to treatment with narrowband UVB two to three times weekly to one half of their body for a total of 16 weeks, while the contralateral side of the body is covered by a special garment to prevent any UVB treatment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Split Body Study of the Effects of Combined Therapy With Narrow-Band Ultraviolet B Phototherapy and Apremilast for the Treatment of Vitiligo
Actual Study Start Date : April 14, 2017
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : June 2019
研究类型:介入(临床试验)
预计报名人数:20人
干预模式:单组分配
干预模型描述:入组的受试者将被随机分配使用窄带UVB治疗，每周2 - 3次，每次半个身体，共16周，而身体的对侧被一件特殊的衣服覆盖，以防止任何UVB治疗
屏蔽:没有(开放标签)
主要目的:治疗
分体研究窄波段紫外B光疗联合Apremilast治疗白癜风的疗效
实际开始时间:2017年4月14日
预计主要竣工日期:2018年11月
预计研究完成日期:2019年6月
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发表于 2018-8-19 06:22:55
楼主