Efficacy and Safety of Combination Therapy of Intralesional 5-Fluorouracil and Triamcinolone Acetonide in Treatment of Keloids and Hypertrophic Scars: A Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Vancouver Scar Scale (VSS) Score
研究概览
简要总结
Pathological scars like keloids and hypertrophic scars (HTS's) cause significant aesthetic, symptomatic and psychological issues to patients. Treatment is challenging with no universally accepted "gold standard" method. Plethora of options is in practice: intralesional (IL) injections, silicon sheets, lasers, cryotherapy, radiotherapy and surgery. This study analysed the effect of combination therapy of IL 5-fluorouracil (5-FU) and triamcinolone acetonide (TAC) in keloids and HTS's.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 16 years or more, with keloids or hypertrophic scar more than 10 mm in size
排除标准
- •Signs of systemic or local infection
- •who underwent treatment for same scar in the past 6 months
- •Renal failure or liver dysfunction or bone marrow suppression
研究组 & 干预措施
Patients aged 16 years or more, with keloids and HTS's more than 10 mm in size
干预措施: Intralesional Triamcinolone 5 mg/ml (Drug)
Patients aged 16 years or more, with keloids and HTS's more than 10 mm in size
干预措施: Intralesional 5-fluorouracil (Drug)
结局指标
主要结局
Vancouver Scar Scale (VSS) Score
时间窗: 12 months
Change in scar severity based on the Vancouver Scar Scale, a validated tool assessing vascularity, pigmentation, pliability, and height. Scale Range: 0 (normal skin) to 13 (worst scarring)
Patient-Reported Pain Score
时间窗: 12 months
Self-reported scar-associated pain using a 10-point Visual Analog Scale (VAS). Scale Range: 0 (no pain) to 10 (worst imaginable pain)
Scar Height
时间窗: 12 months
Change in scar height measured in millimeters (mm) using a standardized caliper.
Patient-Reported Pruritus Score
时间窗: 12 months
Self-reported itch severity related to the scar, measured using a 10-point Visual Analog Scale (VAS). Scale Range: 0 (no itch) to 10 (worst imaginable itch)
Patient-Reported Scar Appearance Score
时间窗: 12 months
Self-reported perception of scar appearance using a 10-point Visual Analog Scale (VAS). Scale Range: 0 (no visible scar) to 10 (worst possible scar appearance)
次要结局
未报告次要终点
研究者
Prajjwol Luitel
Principal Investigator
Maharajgunj Medical Campus