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临床试验/NCT07055529
NCT07055529尚未招募1 期

Comparison of Efficacy and Safety Psoralen Combined With Ultraviolet A (PUVA) Vs Tofacitinib in the Treatment of Generalized Vitiligo.

Hayat Abad Medical Complex, Peshawar1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2026年6月1日最近更新:
干预措施

试验速览

阶段
1 期
状态
尚未招募
发起方
入组人数
64
试验地点
1
主要终点
Assesment of repigmentation

研究概览

简要总结

This study aims to compare the efficacy and safety of PUVA versus Tofacitinib in the treatment of generalized vitiligo. Given the high prevalence of vitiligo in Pakistan and the significant psychosocial impact on patients, particularly in Peshawar, this study will provide valuable insights into optimal treatment strategies.

详细描述

Vitiligo is a chronic skin condition that occurs due to the loss of melanocytes, which results in the loss of skin colour. Vitiligo seems to be a common disease. An estimated 0.5-2% of people in the world suffer from it.1 It affects the quality of life because of being visible and often being stigmatized.1 In a study appearing in the Journal of Pakistan Association of Dermatologists, researchers studied familial prevalence and association of vitiligo with other auto-immune diseases in Pakistan. The study found 22% of vitiligo patients had a positive family history, thus suggesting a genetic predisposition. 2 There are many treatment options of varying efficacy available for vitiligo. For many years, PUVA (oral Psoralen plus ultraviolet A) therapy has been used to treat generalized vitiligo. This therapy promotes the repigmentation of the skin by facilitating the migration and proliferation of melanocytes. PUVA therapy has been shown to produce repigmentation rates between 50-75% in responsive patients, particularly on the face and trunk.3 However, PUVA therapy needs close monitoring due to the risk of phototoxicity, gastrointestinal symptoms and longer-term risks of skin aging and carcinogenesis.4 Recent times have seen a rise in the use of new treatments such as Janus kinase (JAK) inhibitors like Tofacitinib for generalized vitiligo.5 Tofacitinib an oral JAK inhibitor, works through the modulation of the immune response believed to cause the autoimmune destruction of melanocytes. Clinical trials show Tofacitinib has repigmentation rates of 45-65%, and is better tolerated than conventional therapies such as PUVA.6 In the study "Tofacitinib to Treat Refractory Progressive Vitiligo: A Retrospective Case Series," 25 patients with refractory progressive vitiligo were treated with oral tofacitinib. Out of these 16 (64%) patients, the progression of disease ceased. Almost half of these patients observed this effect within one month. In addition 10 patients (40%) showed various degrees of repigmentation. The study pointed out that tofacitinib with phototherapy had a significant effect on repigmentation rate. General findings indicate that oral tofacitinib is probably effective for intractable progressive vitiligo.7 JAK inhibitors are potentially a safer and effective alternative treatment option for vitiligo patients.8 Although useful, there isn't much direct knowledge of PUVA versus Tofacitinib efficacy in the Pakistani population. Due to variations in genetic make-up, environmental conditions, and access to healthcare, the present study serves as a justification for carrying out such studies in order to determine the best treatment option for patients with generalized vitiligo.

The objective of this study is to compare the efficacy and safety of PUVA and Tofacitinib in generalized vitiligo. Because of the high frequency of vitiligo in Pakistan and the considerable psychosocial impact of the disease on the patients of Peshawar, the current study will yield useful information regarding the best course of action on treatments.

OBJECTIVE To compare the efficacy and safety of PUVA versus Tofacitinib in the treatment of generalized vitiligo.

Operational Definitions

Vitiligo

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • • Patients of either gender aged 18-60 years, diagnosed with generalized vitiligo (depigmentation affecting more than 10% of the body surface area).
  • Stable vitiligo (no new lesions or progression of existing lesions in the last three months).

排除标准

  • Patients with a history of photosensitivity or allergies to Psoralen or Tofacitinib in order to prevent adverse reactions that could compromise patient safety and interfere with treatment efficacy assessment.
  • Pregnant or lactating women in order to ensure fetal and neonatal safety, as the effects of Psoralen and Tofacitinib on pregnancy and breastfeeding are not well studied and could pose potential risks.

研究组 & 干预措施

Group B in which the patient will be given Tofacitinib 5mg

Other

This study will have two groups and this group will recieve tablet tofacitinib 5mg

干预措施: Group B receiving Tablet Tofacitinib (Drug)

Group A in which the patient will recieve PUVA therapy

Other

The Study will have two groups and in this group patients will recieve Psoralen combined with UVA (PUVA) therapy

干预措施: Group A recieving PUVA therapy (Drug)

结局指标

主要结局

Assesment of repigmentation

时间窗: Six Months

Efficacy in this study will refer to the degree of repigmentation achieved, which will be measured using the Vitiligo Area Scoring Index (VASI) (Annex-1) to assess the percentage of repigmented skin in affected areas. A treatment will be deemed effective if it achieves at least 50% repigmentation in depigmented patches, as evaluated by VASI over a six-month period.

次要结局

未报告次要终点

研究者

发起方
Hayat Abad Medical Complex, Peshawar
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Syeda Sana Zaman

Trainee Medical Officer

Hayat Abad Medical Complex, Peshawar

研究点 (1)

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