NCT01101360已完成不适用
Evaluation of Fractional Radiofrequency (Matrix RF) Stand Alone and Combined With PDL Treatment on Port Wine Stains
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Adverse events recording and monitoring
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of the Matrix RF for Port Wine Stains based on clinical and histological analyses.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent agreement signed by the subject.
- •Healthy males or females older than 18 to 65 years of age.
- •Having a low to mid depth Port Wine Stain of at least 5 cm
- •Willingness to follow the treatment and follow-up schedule and the post-treatment care.
- •For female candidates - post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study (i.e., oral contraceptives, IUD, contraceptive implant, barrier methods with spermicide, or abstinence).
排除标准
- •PWS on lower legs or hands.
- •Pregnant and/or breastfeeding.
- •Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator.
- •Having a permanent implant in the treated area, such as an injected chemical substance in the face (if treated).
- •Having a history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treated area, unless treatment is conducted following a prophylactic regimen.
- •Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g., ibuprofen-containing agents) one week before and after each treatment session.
- •Use of retinoids, antioxidants or medical grade of skin nourishing supplements within 2 months of treatment or during the study.
- •Having received a facial dermabrasion or chemical peel treatment within 3 months of treatment or during the study (if face is treated).
- •Having received treatment with light, RF or other devices in the treated area within 6 months of treatment or during the study.
- •Having received Botox/collagen/fat injections or other methods of augmentation with injected or implanted material in the treated area within 9 months of treatment or during the study (if face is treated).
- •Having undergone a resurfacing procedure, face lift or eyelid surgery within a year of treatment or during the study (if face is treated).
- •Having undergone any other surgery in the treated area within 6 months of treatment (or more if skin has not healed completely) or during the study.
- •History of keloid scarring or of abnormal wound healing.
- •Suffering from current or history of significant skin conditions in the treated area or inflammatory skin conditions, including, but not limited to: active acne, excessive skin dryness, psoriasis, eczema, rash, rosacea (particularly severe open wound stage), varicella scars, open lacerations or abrasions and active cold sores or herpes sores prior to treatment (duration of resolution as per the Investigator's discretion) or during the treatment course.
- •History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications.
- •History of epidermal or dermal disorders (particularly if involving collagen or microvascularity).
- •History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation.
- •Suffering from hormonal imbalance, as per the Investigator's discretion.
- •Having a known anticoagulative or thromboembolic condition or taking anticoagulation medications one week prior to and during the treatment course (to allow inclusion, temporary cessation of use as per the subject's physician discretion).
- •Having or undergoing any form of treatment for active cancer, or having a history of skin cancer or any other cancer in the areas to be treated, including actinic keratosis, presence of malignant or pre-malignant pigmented lesions.
- •Suffering from significant concurrent illness, such as cardiac disorders, diabetes (type I or II), or pertinent neurological disorders.
- •Tattoo or permanent make-up in the treated area.
- •Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study.
- •Participation in a study of another device or drug within three month prior to enrollment or during the study.
- •As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
结局指标
主要结局
Adverse events recording and monitoring
时间窗: Up to 40 weeks
Time to complete healing
时间窗: Up to 30 weeks
Assess safety of the Matrix RF treatment for port wine stains
次要结局
- Lightening of the port wine stain(Up to 40 weeks)
- Reduction in blood vessel concentration(Up to 40 weeks)
- Clearance of port wine stain(Up to 40 weeks)
- Improvement of port wine stain(Up to 30 weeks)
研究者
研究点 (1)
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