Efficacy and Safety of Intralesional Insulin in Comparison to Intralesional Corticosteroids in the Management of Keloids: A Non Inferiority Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Compare the effectiveness of keloid severity using Vancouver scar scale
研究概览
简要总结
This study is a single-blinded non inferiority trial that aims to compare the efficacy and safety of intralesional insulin and intralesional corticosteroids in the management of keloids. The study will include patients aged 18 and above with keloids, who will be randomly allocated to receive either intralesional insulin or intralesional triamcinolone acetonide. The primary outcome measure will be the Vancouver Scar Scale (VSS) score, while secondary outcomes will include individual components of VSS, adverse effects, and recurrence rate. The study expects to recruit 94 participants and will be conducted over 24 months. Data collection will be done on presdesigned case record form and stored in Excel. Data analysis will be done as per intention to treat analysis. If proven effective, intralesional insulin could serve as a safe, affordable alternative to steroids in keloid treatment, improving patient outcomes and reducing side effects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •No prior treatment for keloids in the past 2 months and are willing to follow up.
排除标准
- •Pregnancy, Lactation, patient on immunosuppressants and anticoagulants, local site infection, ear lobe keloid, hypertrophic scars, diabetes.
结局指标
主要结局
Compare the effectiveness of keloid severity using Vancouver scar scale
时间窗: Baseline, week 9 and week 24
次要结局
- 1.To assess and compare individual components of VSS (vascularity, height, pliability and pigmentation) 2.Compare the adverse effect(3.Recurrence rate)
研究者
M Nisha
Indira Gandhi Medical College and Research Institute