Effectiveness of Microneedling and Topical Latanoprost in Treatment of Acrofacial Vitiligo
试验速览
- 阶段
- 2 期
- 入组人数
- 70
- 主要终点
- Improvement in VASI score
研究概览
简要总结
To compare efficacy of topical latanoprost preceded by microneedling versus topical latanoprost alone in treatment of acrofacial vitiligo.
详细描述
patients meeting inclusion and exclusion criteria presented to Dermatology Outpatient Clinic, Sohag University Hospital will be enrolled in the study after obtaining a written consent from them. Full history will be obtained and meticulous examination will be carried out. Patients will be randomly divided into 2 groups, one group will receive topical latanoprost with microneedling, and the other one will receive topical latabnoprost alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acrofacial stable vitiligo for 6 months duration (without new lesions appearance or change in size of the existing lesions).
排除标准
- •History of scar formation.
- •Patients with systemic diseases (diabetes, bleeding disorders, chronic renal diseases, chronic liver diseases, asthma and hypertension).
- •Patients who are receiving chemotherapy or radiotherapy.
- •Pregnant and lactating females.
研究组 & 干预措施
Microneedling + latanoprost
patient will receive topical application of latanoprost 0.005% eye drops solution twice daily for 3 months preceded by microneeding in sessions by dermapen every 2 weeks for 3 months (totally 6 sessions).
干预措施: Latanoprost (Drug)
Microneedling + latanoprost
patient will receive topical application of latanoprost 0.005% eye drops solution twice daily for 3 months preceded by microneeding in sessions by dermapen every 2 weeks for 3 months (totally 6 sessions).
干预措施: Microneedling (Device)
latanoprost
Patient will receive topical application of latanoprost 0.005% eye drops solution only twice daily for 3 months (active control side).
干预措施: Latanoprost (Drug)
结局指标
主要结局
Improvement in VASI score
时间窗: 6 months
VASI score: The percentage of vitiligo involvement is calculated in terms of hand units. One hand unit is approximately equivalent to 1% of the total body surface area. The degree of pigmentation is estimated to the nearest of one of the following percentages: * 100% - complete depigmentation, no pigment is present * 90% - specks of pigment present * 75% - depigmented area exceeds the pigmented area * 50% - pigmented and depigmented areas are equal * 25% - pigmented area exceeds depigmented area * 10% - only specks of depigmentation present. The VASI for each body region is determined by the product of the area of vitiligo in hand units and the extent of depigmentation within each hand unit measured patch. Total body VASI = S All body sites \[Hand Units\] x \[Residual depigmentation\]. (Feily et al., 2014).
次要结局
未报告次要终点
研究者
Noreen Ismail AbdelGhani Ahmed
resident at general administration of medical affairs
Sohag University