Treatment of Port Wine Stains Using Pulsed Dye Laser, Erbium Yag Laser and Topical Sirolimus in an Open Label Pilot Study (POLAR).
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Percentage clearance assessed colorimetrically
研究概览
简要总结
The purpose of this study is to improve the therapeutic outcome of laser therapy for port wine stains by using a combination treatment of the pulsed dye laser (PDL), erbium yag laser and topical sirolimus.
详细描述
In the first treatment period all patients will receive a total of five treatments with two week intervals. Every patient will receive the following four treatments (utilizing a template with separate squares of 1cm2): 1) PDL treatment followed by topical sirolimus application after Er:Yag laser ablation of the stratum corneum compared with 2) PDL treatment followed by topical sirolimus application without Er:Yag laser ablation of the stratum corneum, 3) PDL treatment only and 4) sirolimus application only. After the six months follow-up period, during the second treatment period, patients will receive an additional five treatments of the adjacent cosmetic unit of the treated part of the PWS, employing the most successful of the four treatment modalities as evaluated after the first treatment period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- 是
入选标准
- •Subject has provided informed consent;
- •Subject is ≥ 18 years of age at time of screening;
- •Subject has an extra-facial homogenous Port Wine Stain (PWS);
- •The PWS is large enough in size to fit one of the templates
- •Subject has not received any laser treatment of the PWS in the last 3 months (in the treatment area);
- •The PWS has a minimal erythema grading score of 3 (on a 4 point scale) in the opinion of the investigator;
- •Screening blood safety values are within normal parameters or regarded as not clinically significant in the opinion of the investigator.
排除标准
- •PWS with a nodular/hypertrophic component in the treatment area;
- •PWS on cosmetically unacceptable locations in the opinion of the investigator;
- •For women: pregnant or breast feeding during the treatment period;
- •Women of child-bearing potential, unless they are using adequate contraceptive measures
- •Subject is known to have immune deficiency, or is immune compromised
- •Known allergy to sirolimus or other constituents of the study medication;
- •Incapacitated subjects;
- •Any medical or psychiatric condition which, in the investigator's opinion, would preclude the participant from adhering to the protocol or completing the study per protocol.
研究组 & 干预措施
sirolimus topical 40microgram/cm2
sirolimus topical 40microgram/cm2
干预措施: Sirolimus (Drug)
Pulsed Dye Laser + Erbium yag + sirolimus
Pulsed Dye Laser + Erbium yag laser + topical sirolimus
干预措施: Sirolimus (Drug)
Pulsed Dye Laser + topical sirolimus
Pulsed Dye Laser + topical sirolimus
干预措施: Sirolimus (Drug)
Pulsed Dye Laser + Erbium yag + sirolimus
Pulsed Dye Laser + Erbium yag laser + topical sirolimus
干预措施: Erbium yag laser (Other)
Pulsed Dye Laser + Erbium yag + sirolimus
Pulsed Dye Laser + Erbium yag laser + topical sirolimus
干预措施: Pulsed Dye Laser (Device)
Pulsed Dye Laser + topical sirolimus
Pulsed Dye Laser + topical sirolimus
干预措施: Pulsed Dye Laser (Device)
Pulsed Dye Laser
Pulsed Dye Laser
干预措施: Pulsed Dye Laser (Device)
结局指标
主要结局
Percentage clearance assessed colorimetrically
时间窗: 10 weeks
次要结局
未报告次要终点
研究者
M.B.A. van Doorn
MD, PhD
Erasmus Medical Center