A Hospital Based Randomized Controlled Trial Comparing the Efficacy of Intralesional Triamcinolone versus Alternating Intralesional Triamcinolone and Insulin in the Management of Keloids
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
研究概览
简要总结
Keloids are benign fibroproliferative growths that arise due to an exaggerated wound healing response following cutaneous injury. They represent a significant therapeutic challenge owing to their high recurrence rates and variable response to conventional modalities. Intralesional corticosteroids, particularly Triamcinolone acetonide (TAC), are widely regarded as the first-line treatment; however, they are often limited by suboptimal efficacy and local adverse effects. Insulin has been reported to possess tissue remodeling, angiogenic, and anti-fibrotic properties that may enhance scar maturity and improve clinical outcomes. This randomized controlled trial aims to compare the efficacy of intralesional Triamcinolone alone versus alternating intralesional Triamcinolone and Insulin in the management of keloids. Patients will receive monthly sessions of either intralesional Triamcinolone or alternating intralesional Triamcinolone and Insulin for 18 weeks, followed by a 12 weeks observation period. The therapeutic response will be evaluated using the Patient and observer scar assessment scale(POSAS) at baseline, 18 weeks, and 30 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Adults aged 18 to 60 years with a clinical diagnosis of keloid(s) more than 6 months in duration.
- •Lesion size between 0.5 cm and 10 cm in diameter.
- •No prior intralesional treatment within the last month.
- •Willing and able to comply with treatment schedule and follow-up visits.
- •Provided written informed consent.
排除标准
- •Active infection or ulceration at the treatment site.
- •Hypertrophic scar (not keloid).
- •History of allergy to triamcinolone or insulin.
- •Known diabetes mellitus or simultaneous Insulin/ oral hypoglycemic agents use.
- •Significant hepatic, renal, or cardiovascular illness.
- •Pregnant or breastfeeding women.
- •Coagulopathy or current use of anticoagulant medication.
研究者
Ravi Daiya
All India Institute of Medical Sciences, Gorakhpur
