Microneedling With 5-Fluorouracil Versus Intralesional 5-Fluorouracil or Corticosteroids for Hypertrophic Scars and Keloids
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- the efficacy
研究概览
简要总结
The goal of this clinical trial is to learn about the efficacy and safety of microneedling-assisted 5-fluorouracil delivery in comparison with intralesional 5-fluorouracil, intralesional corticosteroid, and microneedling with saline for the treatment of pathological scars.
详细描述
Hypertrophic scars and keloids are dermal fibroproliferative disorders unique to humans. They are common and usually occur following burns, trauma, inflammation, or surgery, but sometimes occur spontaneously. Despite an array of therapeutic approaches for scar therapy such as surgical excision, occlusive dressings, topical and intralesional corticosteroids, interferon, cryosurgery, radiation, pressure therapy, laser therapy, retinoic acid, and silicone gel sheeting, no single method provides complete benefit. For this reason, the medical care of HTSs and keloids remains clinically challenging. The study was conducted on 60 patients complaining of HTSs & keloids.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcomes assessor will be blinded to the treatment allocation to reduce assessment bias during evaluation of scar improvement.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients diagnosed with HTSs or keloids
排除标准
- •pregnant or lactating females, immunocompromised patients
研究组 & 干预措施
Microneedling with 5-Fluorouracil
Intervention Name: Microneedling With 5 Fluorouracil Intervention Type: Procedure
干预措施: Microneedling with 5-Fluorouracil (Procedure)
Intralesional 5-Fluorouracil
Intervention name: Intralesional 5-Fluorouracil Intervention Type: drug
干预措施: Intralesional 5-fluorouracil (Drug)
Microneedling with normal saline
Intervention name: Microneedling with normal saline Intervention type: Procedure
干预措施: Microneedling With saline (Procedure)
结局指标
主要结局
the efficacy
时间窗: 3 weeks
to detect the Change in scar severity assessed by the Vancouver Scar Scale
Vancouver Scar Scale
时间窗: 3 weeks
To detect the Change in scar severity assessed by the Vancouver Scar Scale based on four scar characteristics (vascularity 0-3, pliability 0-5, height 0-3, pigmentation 0-2) with the minimum total score 0 (normal) and the maximum total score 13 (most severe scar). Higher scores after treatment mean worse outcome.
ImageJ Analysis
时间窗: 3 weeks
To objectively assess scar surface area. To quantify treatment effect, the percentage of change in scar area was calculated for each patient using the formula: ■("Percentage of change=" ("Post treatment area - Baseline area" /"Baseline area" )"×100" ), Higher scores mean worse outcomes.
次要结局
- Patient's satisfaction score(3 weeks)
- visual analogue scale(3 weeks)
研究者
Shimaa Ismail Abdelhamid
Associate Professor of Dermatology
Alexandria University