Effect of Vitamin D Injection on Hypertrophic Scars and Keloids
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Clinical scoring by Vancouver Scale Score
研究概览
简要总结
Scars and keloids cause patients severe morbidity and psychological distress. Hypertrophic scars rise above the skin but stay within the scar boundaries, while keloids expand.
The development of keloids and hypertrophic scars is a consequence of insufficient wound healing. These lesions are distinguished by excessive ECM deposition. Excessive ECM deposition is caused by increased inflammatory and proliferative processes and decreased remodeling activities. These scarring lesions are also linked to genetic and systemic causes
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 12 years to 50 years. Patients with hypertrophic scars and keloids
排除标准
- •Age below 12 years and above 50 years. Patients received other treatment modalities for hypertrophic scars and keloids.
- •Systemic and other skin diseases. Patients were already receiving supplemental vitamin D.
研究组 & 干预措施
vitamin D deficiency
patients with vitamin D deficiency or insufficiency (<12 ng/ml and 12-19 ng/ml, respectively) received systemic and intralesional vitamin D injections
干预措施: Cholecalciferol (Drug)
vitamin D sufficiency
Patients with vitamin D sufficiency (20 and greater ng/mL) of vitamin D received only intralesional injections of vitamin D on hypertrophic scars and keloids.
干预措施: Cholecalciferol (Drug)
结局指标
主要结局
Clinical scoring by Vancouver Scale Score
时间窗: 3 months
Four characteristics of the scar are assessed. These are: vascularity, height, pliability, and pigmentation. Each characteristic is given a score, which are added together to give an overall score between 0 and 13
次要结局
未报告次要终点
研究者
Mostafa Bahaa
Teaching assisstant
Tanta University