A study to sequentially determine the dermatoscopic features of vitiligo and its correlation with disease activity and treatment response
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To sequentially determine the dermatoscopic features of vitiligo
研究概览
简要总结
Vitiligo is one of the common acquired pigmentary disorders, which is characterized by depigmentation as a result of the loss of melanin producing cells also known as melanocytes. The prevalence rate of vitiligo in the world approximates around 1%, while in India it goes up to 8.8%, making it a significant proportion of patients seen in dermatology services. The dark complexion of ethnic skin combined with social stigma and lack of knowledge about the disease in the general population causes a lot of psychological distress to affected patients.
Vitiligo is characterized by milky or ivory white sharply demarcated macules, often symmetrical on both sides of the body. The size of the lesions may vary from a few millimetres to several centimetres. The most common sites affected are the ones which are prone to repeated trauma or chronic pressure or friction like hips, dorsum of hands and feet, ankles, elbows and knees. The natural course of the disease is highly unpredictable as well, with periods of abrupt onset, active disease, then stability or repigmentation and rapid progression after a period of dormancy.
There are many theories and hypothesis suggesting the pathophysiology of vitiligo: genetic, biochemical, neural, autoimmune, defective free radical defence, etc. In spite of this, vitiligo still remains an idiopathic disorder, with more than one factor at play in a single individual.
Conventional medical therapies have used both topical and oral treatment. First line therapies are usually topical steroids or topical calcineurin inhibitors like tacrolimus.3 Oral mini pulse therapy using dexamethasone is used for rapidly progressive or active disease and has shown to halt the disease activity and caused repigmentation in some patients.3 Other therapies like antioxidants, systemic phototherapy i.e. psoralen and ultraviolet A (PUVA), ultraviolet B (UVB) therapy, laser therapy are also being used. Surgery as a therapeutic option is kept for patients who have stable disease and are not responding to medical therapies. This mostly includes autologous grafting techniques, both tissue and cellular (both cultured and non-cultured).
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 1.00 Day(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •A clinical diagnosis of vitiligo (segmental or non-segmental type)
- •Active disease defined as VIDA score of 4+
- •Two independent areas/lesions of of size 2 x 2 cm to 6 x 6 cm showing clinical signs of progressive vitiligo
- •Patients who are yet to be initiated on medical management.
- •A wash off period of 4 weeks for topical and 12 weeks for systemic treatment will be ensured.
排除标准
- •Stable disease
- •Patients with only mucosal vitiligo
- •Patients receiving phototherapy or surgical management
- •Patients who refuse to give consent for participation in the study.
结局指标
主要结局
To sequentially determine the dermatoscopic features of vitiligo
时间窗: Baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks
次要结局
- 1. To correlate the dermatoscopic features with disease activity assessed by means of VIDA and VASI.(2. To correlate the dermatoscopic features of repigmentation with treatment modality used.)
