A prospective, comparative, randomised study on efficacy, safety and tolerability of topical tofacitinib vs topical tofacitinib with puvasol in the management of vitiligo.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- To assess the clinical efficacy of topical tofacitinib vs topical tofacitinib with puvasol in vitiligo patients with respect to repigmentation of skin
研究概览
简要总结
Vitiligo is a chronic pigmentary skin disorder presenting with depigmented patches. The course of the disease is unpredictable and there are various treatment options available. This is a prospective, comparative, randomised clinical study to assess the safety, efficacy and tolerability of topical tofacitinib vs topical tofacitinib with puvasol in the treatment of vitiligo. Each group will have 33 patients each. The study will be conducted at a tertiary hospital. One group will be treated with 2% topical tofacitinib cream applied twice daily for a period of 4 months. The other group will be treated with 2% topical tofacitinib cream applied twice daily along with oral trioxsalen 20-40 mg give thrice a week 2 hours before sun exposure with 48 hours spacing for a period of 4 months. Thus the study aims to find the best possible results in the management of vitiligo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 12.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients who are clinically diagnosed cases of vitiligo 2)Both sexes – males and females 3)Age – above 12 years to 60 years 4)Body surface area involving the depigmented patches of less than 10% 5)Depigmented patches in exposed areas of the body.
排除标准
- •Patients having vitiligo patches in more than 10% BSA and having patches over flexure areas and genitals 2)Patients with active or latent TB 3)Patients with anaemia (Hb < 9g/dl) ,liver diseases, kidney disease, GI disease (diverticulitis, perforation ,ulcers ) , respiratory disease (ILD , COPD, pulmonary edema) 4)Patients with malignancies or lymphoproliferative disorders 5)Patients on potent immunosuppresants, biological DMARDS , H/O organ transplant 6)Patients with deranged lipid profile 7)H/O recent live vaccination 8)Age less than 12 years, pregnancy and lactation 9)Family history of melanoma/non melanoma skin cancers 10)People suffering from photosensitivity disorders.
结局指标
主要结局
To assess the clinical efficacy of topical tofacitinib vs topical tofacitinib with puvasol in vitiligo patients with respect to repigmentation of skin
时间窗: 4 months
次要结局
- To know the safety and tolerability of topical tofacitinib vs topical tofacitinib with puvasol in treatment of vitiligo.