Randomized Controlled Evaluator-blinded Trial of Microneedling for the Treatment of Hypertrophic Scars of Adult Burn Survivors and Patients With Severe Skin Disorders
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Skin Erythema Changes
研究概览
简要总结
Approximately 33 to 91% of severe burn victims will develop hypertrophic scars. Hypertrophic scars are defined as erythematous (red), raised and rigid scars that can cause pain and itching, among other things. They cause psychological distress and affect the quality of life of burn victims. Microneedling is a technique that uses an electrical device to create hundreds of microchannels that penetrate the skin layers. This study is interested in determining the effectiveness of microneedling in improving the pliability, thickness and erythema of hypertrophic scars. Each scar will receive up to 5 ACS-pen treatments followed by the application of cortisone (triamcinolone acetonide). Knowing that microneedling increases the absorption of products applied to the skin by about 80%, it is logical to think that creating these channels to the dermis and applying cortisone afterwards would have a beneficial effect on the hypertrophic scars of these patients.
详细描述
Patients will receive microneedling once every six weeks for a maximum of five treatments
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)
入排标准
- 年龄范围
- 16 Years 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any gender or race
- •16 years of age or older
- •Have at least 2 HSc that meet the clinical criteria for HSc
- •Provide written informed consent.
排除标准
- •Patients with keloid scars
- •Mature scar site
- •A psychiatric condition or cognitive impairment that interferes with their ability to follow the treatment protocol
- •Dermatological conditions (i.e. psoriasis, eczema, etc.) in the area of the evaluation site
- •An allergy to ultrasound gel
- •On anticoagulant medications
- •Inability to understand English or French.
研究组 & 干预措施
Microneedling treated scar
Microneedling
干预措施: Microneedling (Procedure)
Control scar
No intervention, standard of care
结局指标
主要结局
Skin Erythema Changes
时间窗: Baseline, before treatments #3, #4 and #5, post 6 weeks and 12 weeks
Erythema index measure by Mexameter, values from 0 to 999. The erythema values are individual for each person and depend strongly on the ethnic group. The measurements are generally used to determine changes before and after a treatment.
Cutometer Skin Elasticity Changes
时间窗: Baseline, before treatments #3, #4 and #5, post 6 weeks and 12 weeks
Skin elasticity measures (r0- Cutometer), mm
Skin Thickness Changes
时间窗: Baseline, before treatments #3, #4 and #5, post 6 weeks and 12 weeks
Ultrasound skin measures, mm
次要结局
- Patient reported effectiveness of intervention(Baseline, 12 weeks post intervention)
研究者
Bernadette Nedelec
Full professor, McGill University
Centre hospitalier de l'Université de Montréal (CHUM)