A Prospective Triple-Blinded Single-Center Study of Laser-Assisted 5-Fluorouracil Versus Laser-Assisted Corticosteroid Treatment for Keloids
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Patient and Observer Scar Assessment Scale (POSAS) Score From Baseline to Final Visit
研究概览
简要总结
This is a split-scar study with a target sample size of 20. There are two interventions: fractional erbium:YAG-assisted drug delivery of 5-fluorouracil and fractional erbium:YAG-assisted drug delivery of triamcinolone acetonide. Patients will undergo treatments in a series of 4 treatments at approximately 4 week ± 1 week intervals. Investigators will monitor for safety and continued benefit after the end of the interventional treatment.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has one large keloid scar or at least two similar but separate keloid scars
- •Keloid present for at least 1 year
排除标准
- •Currently pregnant
- •Currently breastfeeding
- •Have taken oral retinoids within 6 months of study initiation
- •Has had keloid treatment within 1 month of study initiation
- •Has active infection at treatment site
- •Has active malignancy
- •Presence of pedunculated keloid(s) or keloid(s) that are judged to be best treated with surgical excision first
- •Hypertrophic scars
- •Known hypersensitivity to TAC or 5-FU
- •Chronic systemic corticosteroid or immunosuppressive medication use
- •Has intolerance to anesthesia
- •Has known connective tissue disease
- •Has known infectious disease
研究组 & 干预措施
Site A of keloid scar
One half of keloid scarring on a single subject
干预措施: Fractional erbium:YAG-assisted drug delivery of 5-fluorouracil (Combination Product)
Site B of keloid scar
One half of keloid scarring on a single subject
干预措施: Fractional erbium:YAG-assisted drug delivery of triamcinolone acetonide (Combination Product)
结局指标
主要结局
Change in Patient and Observer Scar Assessment Scale (POSAS) Score From Baseline to Final Visit
时间窗: Baseline, Week 16
POSAS has two components, the observer (physician) portion and the patient portion. The observer grades on a scale of 1 to 10, 10 being the worst scar imaginable, six measures: vascularity, pigmentation, thickness, relief, pliability and surface area. The patient answers six questions regarding the characteristics of the scar, with each question being on a scale of 1 to 10. The scores of each category are summed to get the total POSAS score, with 120 being the highest score and representing the worst scar and 12 being the lowest score.
Change in Modified Hamilton Score
时间窗: Baseline, Week 16
The Hamilton scale consists of 4 items with a score range of 0 to 14, where 14 represents more severe scarring.
次要结局
- Change in Scar Measurement From Baseline to Final Visit(Baseline, Week 16)