Study of the Effectiveness of the ADVATx Laser in the Treatment of Port-wine Stains
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in lesion presentation measured by Investigator Global Assessment (IGA)
研究概览
简要总结
The primary objective of the present study is to get experiences with the use of CE-marked ADVATx laser treatment for port-wine stains.
Secondary objectives: To investigate the clinical efficacy of ADVATx laser treatment for port-wine stains.
To investigate the potential side effects (erythema, hyperpigmentation, oedema, pain, swelling, skin burning, blisters) of the treatment.
Patients in the study will receive ADVATx laser treatment (1 treatment per month for 4 months) The treatment takes approximately 10-30 minutes per session. The treatment lasts for a total of 5 months for one patient. At each treatment session photographic documentation will be performed. PRO will be assessed by a questionnaire. At the end of the study, the patient rates the treatment and improvement on a Patient Satisfaction Scale.
详细描述
Prospective testing and evaluation of a ADVATx, a CE marked device within its intended use, carried out in one centre.
The ADVATx™ laser system, a solid-state laser with wavelengths of 589 nm and 1319 nm. It offers a solution for an exceptionally wide range of indications. It can treat more than 15 indications related to vascular lesions and other dermatological problems with excellent results and high patient safety. It is extremely economical to operate.
Only medical personnel qualified to use medical lasers are authorised to use them.
EUDAMED registration
Advalight card with SRN number:
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
- 7 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient understands the information provided, gives informed consent to participate in the study and is deemed by the investigator to be able to participate,
- •a signed consent form,
- •parental consent is required for patients under 18 years of age,
- •the lesions to be treated are at least 15 cm2,
- •the study is open to Fitzpatrick skin types I-IV.
排除标准
- •Lack of parental consent for patients under 18 years of age,
- •symptoms localised to the central part of the face (cheeks, nose),
- •people with Fitzpatrick skin type V-VI,
- •4. epilepsy,
- •fever, infectious diseases,
- •the patient is within one month or currently enrolled in another clinical trial.
研究组 & 干预措施
AdvaTx laser treated
AdvaTx laser treated patients
干预措施: ADVATx laser treatment (Device)
结局指标
主要结局
Change in lesion presentation measured by Investigator Global Assessment (IGA)
时间窗: 5 months
The IGA is a five-point scale from 0 (no change) to 4 (complete or nearly complete clearance). Three blinded dermatologists will review standardized clinical photographs to evaluate each treated area. Results will be reported as the average IGA score for each treatment method.
次要结局
- Patient satisfaction score(5 months)
- Pain score during laser treatment measured by Visual Analog Score (VAS)(5 months)
研究者
Prof. Dr. Kemény Lajos
Professor, MD, DSc, MHAS
Szeged University