Efficacy, Tolerance and Acceptability of Pulsed Dye Laser on Telangiectasias of the Face and Neckline in Systemic Scleroderma: a Prospective Single-center Open-label Study of 21 Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Evaluation of the decrease in the number of telangiectasia
研究概览
简要总结
This single-center, prospective, open-label, quasi-experimental, intra-individual comparative study will include a consecutive cohort of 21 patients with diffuse or limited, minimally active scleroderma with 3 to 30 years of evolution.
Patients will have 4 sessions of pulsed dye laser 595 nm spaced 8 weeks apart. The final quadruple evaluation by several evaluators will be 2 months after the last session, on the following criteria: evolution of the number of telangiectasia; subjective improvement score (LINKERT scale); impact on quality of life (SKINDEX score); visual analog pain scale (VAS); adverse events (AEs), including discontinuation of treatment due to post-session purpura (AT-PPS); patient satisfaction (yes or no).
详细描述
Primary Objective:
To evaluate the efficacy of pulsed dye laser treatment on facial and neckline telangiectasias in systemic scleroderma by comparing the mean number of telangiectasias.
Secondary Objectives:
Evaluation of the aesthetic efficacy by the patient, observer and adjudication committee Evaluation of the impact on the quality of life after treatment (skindex) Evaluation of treatment tolerance in terms of pain (VAS) and adverse events (purpura, oozing, hyperpigmentation, hospitalization)
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
- •patient followed in dermatology and/or internal medicine at the University Hospital of Caen for systemic scleroderma
- •patient with telangiectasias related to scleroderma
- •patient with an aesthetic prejudice
排除标准
- •Patient with previous laser treatment for facial telangiectasias.
- •Tanned, irritated or traumatized facial skin
- •Patient not affiliated to the Social Security system
- •Pregnancy
研究组 & 干预措施
four pulsed dye laser sessions were administered every eight weeks in the 21 patients
干预措施: pulsed dye laser (Device)
结局指标
主要结局
Evaluation of the decrease in the number of telangiectasia
时间窗: baseline and two months after last intervention
次要结局
- Assessment of quality of life after pulsed dye laser treatment using the SKINDEX questionnaire(baseline and two months after last intervention)