Tarafdar Dhiman, Sen Indrayudh, Koley Sankha, Ray Biswarup, Sarkar Pinaki, Sil Amrita, Ghosh Arghyaprasun, Das Nilay K
From the Department of Dermatology, Bankura Sammilani Medical College, Kenduadihi, Bankura, West Bengal, India.
From the Department of Ophthalmology, Bankura Sammilani Medical College, Kenduadihi, Bankura, West Bengal, India.
Indian J Dermatol. 2025 Mar-Apr;70(2):115. doi: 10.4103/ijd.ijd_78_24. Epub 2025 Feb 27.
Vitiligo is an acquired multifactorial depigmentation disorder with dreadful social stigma without any gold standard treatment option. Treatment of unstable vitiligo is, furthermore limited. Hydroxychloroquine has shown promise in a few case reports.
The effectiveness, tolerability and safety of narrow-band ultraviolet B (NBUVB)-plus topical clobetasol (group A) versus oral hydroxychloroquine-plus topical clobetasol (0.05%) (group B) were evaluated.
Single-centre, investigator-blind, randomised, active-controlled, parallel-group phase IV trial (CTRI/2019/07/020345) was conducted on unstable vitiligo of either sex. Patients were randomised into two groups (1:1 allocation ratio), and allocation concealment was ensured by the sequentially numbered, sealed, opaque envelope technique. The assessing physician was unaware regarding treatment allocation. Outcome measures were the vitiligo area scoring index (VASI), vitiligo disease activity score (VIDA) and dermatology life quality index (DLQI). The economic burden of therapy was calculated in terms of travel costs and loss of time for availing of the therapy. Routine haematological and biochemical tests and treatment-emergent adverse events were monitored for safety. The calculated sample size was 82 (5% alpha-error, 80% power, 61.1% and 30% percentage improvement in study groups, 10% drop-out).
Intention-to-treat analysis showed significant improvement in VASI (Friedman's analysis of variance, < 0.01) in group A (1048.00 ± 1450.10 reduced to 933.43 ± 1387.79) and group B (415.00 ± 458.47 reduced to 283.85 ± 386.61) at the end-of-treatment visit (24 week). Improvement was noted from 12 weeks onwards in group A and eight weeks onwards in group B (post-hoc Dunn's test, < 0.001). Within group comparison showed significantly more improvement in group B than group A from eight weeks onwards ( < 0.05, analysis of covariance test with baseline VASI as covariate). A similar result was obtained with VIDA. DLQI significantly improved only in group B. The monthly cost of travel and loss of time were significantly less (Mann-Whitney's test, < 0.5) in group B than group A. No adverse events were noted in either group.
Both NBUVB and hydroxychloroquine combined with topical clobetasol are safe and effective agents in the treatment of vitiligo, though the improvement is more and faster with hydroxychloroquine. With hydroxychloroquine, there is no infrastructural requirement, less travel cost and less loss of working hours as opposed to NBUVB, which needs infrastructural set-up.
白癜风是一种后天性多因素色素脱失性疾病，伴有严重的社会耻辱感，且尚无任何金标准治疗方案。此外，不稳定型白癜风的治疗也很有限。在一些病例报告中，羟氯喹显示出了一定前景。
评估窄谱中波紫外线（NBUVB）联合外用丙酸氯倍他索（A组）与口服羟氯喹联合外用0.05%丙酸氯倍他索（B组）的有效性、耐受性和安全性。
对各性别不稳定型白癜风患者进行了一项单中心、研究者盲法、随机、活性药物对照、平行组IV期试验（CTRI/2019/07/020345）。患者被随机分为两组（分配比例为1:1），并通过顺序编号、密封、不透明信封技术确保分配隐藏。评估医生不知道治疗分配情况。结局指标为白癜风面积评分指数（VASI）、白癜风疾病活动评分（VIDA）和皮肤病生活质量指数（DLQI）。根据交通费用和接受治疗所损失的时间计算治疗的经济负担。监测常规血液学和生化检查以及治疗中出现的不良事件以评估安全性。计算得出的样本量为82例（α错误率5%，检验效能80%，研究组改善百分比分别为61.1%和30%，失访率10%）。
意向性分析显示，治疗结束时（24周），A组（从1048.00±1450.10降至933.43±1387.79）和B组（从415.00±458.47降至283.85±386.61）的VASI均有显著改善（Friedman方差分析，P<0.01）。A组从第12周起、B组从第8周起观察到改善（事后Dunn检验，P<0.001）。组内比较显示，从第8周起，B组的改善明显多于A组（P<0.05，以基线VASI作为协变量的协方差分析检验）。VIDA也得到了类似结果。只有B组的DLQI有显著改善。B组每月的交通费用和时间损失显著低于A组（Mann-Whitney检验，P<0.05）。两组均未观察到不良事件。
NBUVB和羟氯喹联合外用丙酸氯倍他索在治疗白癜风方面都是安全有效的药物，不过羟氯喹的改善效果更明显且更快。与需要基础设施设置的NBUVB不同，使用羟氯喹无需基础设施，交通费用更低，工作时间损失更少。
