Department of Dermatology, Venereology, and Leprology, Postgraduate Institute of Medical Education and Research, Chandigarh, India.
JAMA Dermatol. 2019 Feb 1;155(2):204-210. doi: 10.1001/jamadermatol.2018.4919.
Surgical interventions, notably noncultured epidermal suspension (NCES), are the next line of treatment in patients with vitiligo who fail to respond to medical therapy. Noncultured epidermal suspension is usually performed in patients with vitiligo with duration of clinical stability (DS) of 12 months or longer because DS is a vital parameter in determining outcome of NCES. In this pilot study, we planned to assess the efficacy of a novel combination of noncultured epidermal cell suspension and noncultured dermal cell suspension (NCES and NDCS) in patients with vitiligo with shorter DS (3-6 months).
To compare the efficacy of transplantation of NCES and NDCS vs NCES alone in patients with vitiligo with DS of 3 to 6 months.
DESIGN, SETTING, AND PARTICIPANTS: A single-center randomized clinical trial including 40 patients with focal, segmental, or generalized vitiligo with DS of 3 to 6 months or more than 12 months was carried out. Based on DS, 2 groups including 20 patients each were recruited (DS in group 1, 3 to 6 months; DS in group 2, more than 12 months). Each group was further randomized into 2 subgroups, A and B.
Patients in subgroups 1A and 2A underwent NCES alone, whereas patients in subgroups 1B and 2B underwent NCES and NDCS.
Extent of repigmentation, color match, and pattern of repigmentation at 24 weeks.
Of the 40 study participants, mean (SD) age was 24.9 (4.0) years and 24 (60%) were women; in group 1 with DS for 3 to 6 months, more than 75% repigmentation at 24 weeks was observed in all 10 patients in subgroup 1B (NCES and NDCS) compared with 3 of 10 patients in subgroup 1A (NCES) (100% vs 30%, P = .003). In group 2 (DS > 12 months), the same was observed in 6 of 10 patients in subgroup 2A and 7 of 10 patients in subgroup 2B (NCES) (60% vs 70%, P > .99). The 2 groups and subgroups did not show any significant differences with respect to color matching and pattern of repigmentation.
Combination of NCES and NDCS resulted in excellent response in patients with vitiligo with shorter duration of clinical stability compared with NCES alone. This combination may be used early in the course of stable vitiligo without waiting for a period of 12 months or more since last clinical activity.
ClinicalTrials.gov identifier: NCT03013049.
对于未能对药物治疗产生反应的白癜风患者，手术干预（尤其是未培养的表皮悬浮液（NCES））是下一步的治疗方法。通常在白癜风患者的临床稳定期（DS）为 12 个月或更长时间时进行非培养表皮悬浮液治疗，因为 DS 是决定 NCES 治疗效果的重要参数。在这项初步研究中，我们计划评估新型非培养表皮细胞悬浮液和非培养真皮细胞悬浮液（NCES 和 NDCS）联合治疗 DS 为 3 至 6 个月的白癜风患者的疗效。
比较 3 至 6 个月 DS 与单独进行 NCES 移植治疗白癜风患者的疗效。
设计、地点和参与者：这是一项单中心随机临床试验，纳入了 40 名 DS 为 3 至 6 个月或超过 12 个月的局限性、节段性或全身性白癜风患者。根据 DS，招募了每组 20 名患者（第 1 组 DS 为 3 至 6 个月；第 2 组 DS 为 12 个月以上）。每组进一步随机分为 2 个亚组，A 和 B。
亚组 1A 和 2A 的患者接受单独的 NCES 治疗，而亚组 1B 和 2B 的患者接受 NCES 和 NDCS 治疗。
24 周时的复色程度、颜色匹配和复色模式。
在 40 名研究参与者中，平均（SD）年龄为 24.9（4.0）岁，24 人（60%）为女性；在 DS 为 3 至 6 个月的第 1 组中，与亚组 1A（NCES）的 3 名患者（30%）相比，亚组 1B（NCES 和 NDCS）的所有 10 名患者中，24 周时复色程度超过 75%（100%，P = .003）。在第 2 组（DS >12 个月）中，亚组 2A 的 10 名患者中有 6 名和亚组 2B 的 10 名患者中有 7 名（60% vs 70%，P > .99）情况相同。两组和亚组在颜色匹配和复色模式方面均无显著差异。
与单独使用 NCES 相比，NCES 和 NDCS 的联合应用可使白癜风患者在较短的临床稳定期内获得极佳的疗效。这种联合治疗可以在稳定的白癜风病程早期使用，而无需等待最后一次临床活动后 12 个月或更长时间。
ClinicalTrials.gov 标识符：NCT03013049。
