Comparison of efficacy of intralesional vitamin D3 vs intralesional triamcinolone acetonide injection in keloid- A Randomised non inferiority study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Lesions will be assessed by clinical examination, Vancouver Scar Scale (VSS), digital photograph and Visual Analogue Scale for pain during treatment.
研究概览
简要总结
This study is a randomized controlled trial comparing the safety and efficacy of intralesional triamcinolone versus intralesional vit D3 injection in the treatment of keloid . lesions will be assessed by clinical examination, VSS scale, digital photograph and visual analog scale for pain during treatment. Assessment will be done at baseline and every 3 weeks and 1 month after the last dose. The clinical improvement will be defined as decreasing values of the score and complete recovery as the score reach to zero. Scar flattening will be considered as <1mm scar height over 90% of the lesion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •All patients with keloids above 18 years of age.
- •patients having two or more than two keloids not more than 5cm
- •No treatment done for keloids in last 6 months.
排除标准
- •Pregnancy and lactation
- •Family history of keloids.
- •Diabetes mellitus.
- •4.keloids on face.
结局指标
主要结局
Lesions will be assessed by clinical examination, Vancouver Scar Scale (VSS), digital photograph and Visual Analogue Scale for pain during treatment.
时间窗: Assessment will be done at baseline and every 3 weeks and 1 month after last dose.
次要结局
- The clinical improvement will be defined as decreasing values of the scores and complete recovery as scores reach to zero.(Scar flattening will be consired as 1mm scar height over 90% of the lesion)