The Application of Intralesional 5-fluorouracil for the Management of Hypertrophic Facial Scars in the Periocular Region Resulting From Trauma and Surgical Procedures in Individuals Aged Over 18 Years
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Reduction in the size of facial hypertrophic scars
研究概览
简要总结
To determine the effectiveness of intralesional 5-fluorouracil in objectively reversing hypertrophic scars in the periocular region resulting from trauma or cosmetic surgery.
详细描述
During the initial visit, informed consent will be obtained and documented, alongside baseline photographs and measurements of the facial scar dimensions using a ruler. In the subsequent visits-second, third, fourth, and fifth-0.5 ml of intralesional 5-fluorouracil, diluted to 25 mg/ml, will be administered. Clinical photographs will be captured, and dimensions will be measured at each of these visits. A total of 0.5 ml of this solution will be injected weekly into the lesion to be treated, amounting to four doses over the course of one month.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Male or female participants aged ≥18 years.
- •Presence of a facial scar in the periocular region secondary to trauma or facial cosmetic surgery.
- •Ability and willingness to provide written informed consent.
- •Signed informed consent form prior to participation.
排除标准
- •Presence of active local infection in the periocular region.
- •Active inflammatory dermatologic or ocular disorders in the treatment area.
- •Known allergy or hypersensitivity to 5-fluorouracil.
- •Pregnancy or breastfeeding.
- •Inability to comply with follow-up visits.
- •Withdrawal of consent during the study.
- •Development of significant local or systemic adverse reactions during the study period.
研究组 & 干预措施
Intralesional administration of 5-fluorouracil will be conducted in the periocular scar group
For the objective assessment of baseline status and subsequent facial skin changes, the validated Manchester Scar Scale will be used, which is a visual photonumeric scale for evaluating scar quality. This scale assesses six skin parameters, such as color, contour, distortion, texture, and brightness, assigning values from 1 to 4, with 1 indicating the best characteristic and 4 the least desirable.
干预措施: Intralesional administration of 5-fluorouracil (Drug)
结局指标
主要结局
Reduction in the size of facial hypertrophic scars
时间窗: From enrollment to the end of treatment at 4 weeks
To objectively assess baseline status and subsequent changes in facial skin, the validated photometric visual scale from Manchester, designed for evaluating scar quality, will be employed. This scale assesses six skin parameters, including coloration, contour, distortion, texture, and brightness, assigning values from 1 to 4, where 1 represents the most favorable characteristic and 4 the least desirable
次要结局
未报告次要终点