A prospective observational study on the efficacy and side effects of oral KUVA ( khellin UV A) SOL therapy in stable vitiligo patients.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- 1.VASI ( Vitiligo Area Scoring Index)
研究概览
简要总结
Vitiligo is an acquired condition resulting in loss of melanocytes causing localized depigmentation affecting 0.5 – 1% of the world’s population. Although it is not a life-threatening condition but it causes severe disï¬guration and considerable emotional and social distress. Both local and systemic PUVA therapies remain ï¬rst-line methods for treating the disease. However, side effects like nausea, headache, vomiting, increased liver transaminases, severe photo-toxic reactions are common in systemic PUVA treatment. These side effects justify the research for photochemotherapeutic agent like Khellin with possible less side effects and potentially same efficacy. In this study, we focus on adding information to the literature about efficacy and adverse effects of KUVA - SOL therapy ( Khellin UV-A SOL) which is a ptomising treatment option for vitiligo. The study will recruit patients who are to be initiated on KUVA SOL therapy coming to Kasturba Hospital, Manipal SKIN OPD.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients with stable lesions.
- •2.Patients between 18 and 60 years of age.
- •3.Patients who give informed consent for the study and photography.
- •4.Patients who can follow up in the opd.
排除标准
- •1.Patients who are unwilling to participate in the study.
- •2.Patients who had used any topical treatment 2 weeks and systemic treatment 4 weeks before starting on KUVA SOL.
- •3.Patients with history of photosensitive disorders, skin cancer, hepatic or renal disease and lesions over genitals.
- •4.Pregnant or lactating women.
- •5.Unstable vitiligo.
- •6.Patients with spontaneous repigmentation of depigmented macules.
结局指标
主要结局
1.VASI ( Vitiligo Area Scoring Index)
时间窗: Every 4 weeks of initiating therapy for total of 16 weeks.
2.VIDA ( Vitiligo Disease Activity)
时间窗: Every 4 weeks of initiating therapy for total of 16 weeks.
3.VAS ( Visual Analogue Scale)
时间窗: Every 4 weeks of initiating therapy for total of 16 weeks.
4.Scoring by Dermosopy Image Processing Methodology.
时间窗: Every 4 weeks of initiating therapy for total of 16 weeks.
5. Side Effects.
时间窗: Every 4 weeks of initiating therapy for total of 16 weeks.
次要结局
- 1. Liver function tests.(2. Renal function tests.)