The Safety and Efficacy of Thermo-mechanical System for Fractional Ablation Associated Triamcinolone Acetonide Drug Delivery for the Treatment of Hypertrophic Scars and Keloids
试验速览
- 阶段
- 不适用
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Antera Elevation Volume - comparing between Thermo-mechanical system for fractional ablation associated triamcinolone acetonide drug delivery and triamcinolone acetonide injection for the treatment of Hypertrophic scars and Keloids
研究概览
简要总结
This study aims to assess the safety and efficacy of Thermo-mechanical system for fractional ablation associated triamcinolone acetonide drug delivery for the treatment of Hypertrophic scars and 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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers without underlying disease
- •Patient with keloid age more than 6 months and keloid thickness more than 1 mm.
排除标准
- •Dermatitis or infection on treatment area
- •Suspected cancer on treatment area
- •Immunocompromised host
- •Pregnancy or lactating woman
- •Recieved corticosteroid injection within 2 months
结局指标
主要结局
Antera Elevation Volume - comparing between Thermo-mechanical system for fractional ablation associated triamcinolone acetonide drug delivery and triamcinolone acetonide injection for the treatment of Hypertrophic scars and Keloids
时间窗: 6 months
Measuring Antera Elevation Volume in mm3
Thickness by caliper (mm) - comparing between Thermo-mechanical system for fractional ablation associated triamcinolone acetonide drug delivery and triamcinolone acetonide injection for the treatment of Hypertrophic scars and Keloids
时间窗: 6 months
cthickness by caliper in mm.
Patient satisfaction quartile scale - comparing between Thermo-mechanical system for fractional ablation associated triamcinolone acetonide drug delivery and triamcinolone acetonide injection for the treatment of Hypertrophic scars and Keloids
时间窗: 6 months
Patient satisfaction quartile scale from 0 - 100%
Vancouver Scar Scale - comparing between Thermo-mechanical system for fractional ablation associated triamcinolone acetonide drug delivery and triamcinolone acetonide injection for the treatment of Hypertrophic scars and Keloids
时间窗: 6 months
Vancouver Scar Scale between 0 to 13
Physician evaluation quartile score - comparing between Thermo-mechanical system for fractional ablation associated triamcinolone acetonide drug delivery and triamcinolone acetonide injection for the treatment of Hypertrophic scars and Keloids
时间窗: 6 months
Physician evaluation quartile score from 0-100%
次要结局
- Side effect of Thermo-mechanical system, Triamcinolone itself, Injection side effect(6 months)
- Side effect of Triamcinolone acetonide injection(6 months)
研究者
Woraphong Manuskiatti, M.D.
Professor
Mahidol University