PDF(Pubmed)
Abstract：
BACKGROUND: A myriad of therapeutic modalities for alopecia areata are available; however, none is of high level of evidence, creating an immense need for the evaluation of other treatment modalities, of which topical sodium valproate is of potential role via proposed decrease in beta-catenin breakdown, despite its well-known side effect of hair fall as an oral therapy.
OBJECTIVE: Evaluating the efficacy and the safety of sodium valproate (SV)-loaded nanospanlastics, in comparison to topical corticosteroids, this is the currently available gold standard topical treatment for patchy AA.
METHODS: A total of 66 patients with patchy AA were randomly assigned to receive either topical mometasone furoate lotion or topical SV applied twice daily to all patches except a control patch, which was left untreated. Clinical, trichoscopic and biochemical assessments of beta-catenin tissue levels and Axin-2 gene expression were carried out at baseline and after 3 months.
RESULTS: Both therapeutic modalities were comparable. Potential efficacy was highlighted by significant improvement in the representative patch, the largest treated patch, to the control patch, the smallest untreated patch in both steroid and valproate groups (p = 0.027, 0.003 respectively). Both beta-catenin levels and Axin-2 gene expression were reduced after treatment, pointing to the inhibitory effect of dominating uncontrolled inflammatory milieu. Baseline beta-catenin was found to significantly negatively correlate with improvement in the representative patch in patients with baseline level above 0.42 ng/ml (p = - 0.042).
CONCLUSIONS: Both topical SV and steroids are of comparable modest efficacy. Thus, further evaluation of SV is due in combination with intralesional steroids and other anti-inflammatory treatment modalities, together with developing individualized approaches based on baseline beta-catenin level.
RESULTS:
UNASSIGNED: NCT05017454, https://clinicaltrials.gov/ct2/show/NCT05017454 .
OBJECTIVE: Evaluating the efficacy and the safety of sodium valproate (SV)-loaded nanospanlastics, in comparison to topical corticosteroids, this is the currently available gold standard topical treatment for patchy AA.
METHODS: A total of 66 patients with patchy AA were randomly assigned to receive either topical mometasone furoate lotion or topical SV applied twice daily to all patches except a control patch, which was left untreated. Clinical, trichoscopic and biochemical assessments of beta-catenin tissue levels and Axin-2 gene expression were carried out at baseline and after 3 months.
RESULTS: Both therapeutic modalities were comparable. Potential efficacy was highlighted by significant improvement in the representative patch, the largest treated patch, to the control patch, the smallest untreated patch in both steroid and valproate groups (p = 0.027, 0.003 respectively). Both beta-catenin levels and Axin-2 gene expression were reduced after treatment, pointing to the inhibitory effect of dominating uncontrolled inflammatory milieu. Baseline beta-catenin was found to significantly negatively correlate with improvement in the representative patch in patients with baseline level above 0.42 ng/ml (p = - 0.042).
CONCLUSIONS: Both topical SV and steroids are of comparable modest efficacy. Thus, further evaluation of SV is due in combination with intralesional steroids and other anti-inflammatory treatment modalities, together with developing individualized approaches based on baseline beta-catenin level.
RESULTS:
UNASSIGNED: NCT05017454, https://clinicaltrials.gov/ct2/show/NCT05017454 .
摘要：
背景：斑秃有无数的治疗方法；然而，没有高水平的证据,对其他治疗方式的评估产生了巨大的需求，其中外用丙戊酸钠通过β-连环蛋白分解的降低具有潜在作用，尽管其众所周知的副作用的头发下降作为一种口服疗法。
目的：评价丙戊酸钠（SV）纳米推拉剂的疗效和安全性，与局部皮质类固醇相比，这是目前可用的斑片AA的黄金标准外用治疗。
方法：共有66例斑片状AA患者被随机分配接受局部糠酸莫米松洗剂或局部SV，每天两次应用于除对照贴片以外的所有贴片，没有得到治疗。临床,在基线和3个月后对β-连环蛋白组织水平和Axin-2基因表达进行镜检和生化评估。
结果：两种治疗方式具有可比性。代表性贴片的显著改善突出了潜在的疗效，最大的治疗贴片，到控制补丁，类固醇和丙戊酸盐组中最小的未治疗斑块（分别为p=0.027，0.003）。治疗后β-catenin水平和Axin-2基因表达均降低，指出控制不受控制的炎症环境的抑制作用。在基线水平高于0.42ng/ml的患者中，基线β-连环蛋白与代表性斑块的改善显着负相关（p=-0.042）。
结论：两种外用SV和类固醇具有相当的适度疗效。因此，对SV的进一步评估应与病灶内类固醇和其他抗炎治疗方式结合使用，同时开发基于基线β-连环蛋白水平的个性化方法。
结果：
■NCT05017454,https://clinicaltrials.gov/ct2/show/NCT05017454.
目的：评价丙戊酸钠（SV）纳米推拉剂的疗效和安全性，与局部皮质类固醇相比，这是目前可用的斑片AA的黄金标准外用治疗。
方法：共有66例斑片状AA患者被随机分配接受局部糠酸莫米松洗剂或局部SV，每天两次应用于除对照贴片以外的所有贴片，没有得到治疗。临床,在基线和3个月后对β-连环蛋白组织水平和Axin-2基因表达进行镜检和生化评估。
结果：两种治疗方式具有可比性。代表性贴片的显著改善突出了潜在的疗效，最大的治疗贴片，到控制补丁，类固醇和丙戊酸盐组中最小的未治疗斑块（分别为p=0.027，0.003）。治疗后β-catenin水平和Axin-2基因表达均降低，指出控制不受控制的炎症环境的抑制作用。在基线水平高于0.42ng/ml的患者中，基线β-连环蛋白与代表性斑块的改善显着负相关（p=-0.042）。
结论：两种外用SV和类固醇具有相当的适度疗效。因此，对SV的进一步评估应与病灶内类固醇和其他抗炎治疗方式结合使用，同时开发基于基线β-连环蛋白水平的个性化方法。
结果：
■NCT05017454,https://clinicaltrials.gov/ct2/show/NCT05017454.
