A Hospital-Based Randomized Controlled Trial comparing the Efficacy of Intralesional Triamcinolone combined with Pentoxifylline versus Intralesional Triamcinolone alone in the treatment of Keloid
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Decrease in Vancouver Scar Scale (VSS) score – Assessment of vascularity, pigmentation, pliability, and height.
研究概览
简要总结
Keloids are non-cancerous overgrowths of scar tissue that develops due to an exaggerated healing response following skin injury. They are often challenging to treat and show limited responsiveness to standard therapies. Intralesional corticosteroids(ILS) like Triamcinolone acetonide are frequently used as first line treatment but are associated with high recurrence rates and local side effects. Pentoxifylline(PTX) is known for its anti-inflammatory and antifibrotic effects, may improve therapeutic outcomes when used in combination with ILS. we are comparing the efficacy of ILS combined with PTX vs ILS(standard comparator) alone in treatment of keloid. Patients will undergo monthly sessions of combination treatment(ILS with PTX) or ILS alone for 6 months and further follow up will be done for a 6 months period. We will assess Vancouver scar scale(VSS) score at 0, 6 months and 12 months.
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
- •1.Age between 18 and 60 years.
- •2.Presence of clinically diagnosed keloid(s) persisting for at least 6 months.
- •4.Keloid size between 0.5 cm and 8 cm in diameter.
- •5.No treatment with intralesional injections within the past 1 month.
排除标准
- •1.Active local skin infections or ulceration at the treatment site.
- •2.History of hypertrophic scar rather than keloid.
- •3.Known hypersensitivity to triamcinolone or pentoxifylline.
- •4.Patients with immunosuppressive or systemic corticosteroid therapy.
- •5.Patients with systemic illness such as uncontrolled diabetes, liver/kidney dysfunction.
- •6.Pregnant or lactating women.
- •7.Bleeding diathesis or anticoagulant use.
- •8.History of epilepsy, peptic ulcer, or recent myocardial infarction (contraindications for pentoxifylline).
结局指标
主要结局
Decrease in Vancouver Scar Scale (VSS) score – Assessment of vascularity, pigmentation, pliability, and height.
时间窗: At 0, 6 and 12 months.
次要结局
- 1.Percentage reduction in keloid size (surface area and thickness)(2.Global photographic assessment – Standardized photos evaluation)
研究者
Ravi Daiya
All India Institute of Medical Sciences, Gorakhpuur