Prospective Clinical Trial to Assess the Performance of a Cyto-selective Cryotherapye "CRYOBEAUTY MAINS ET DECOLLETE" Compared With Liquid Nitrogen Cryotherapy in the Treatment of Solar Lentigines in 30 Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Cryobeauty
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Performance assessment of new cryotherapy device "CRYOTHERAPY MAIN ET DECOLLETE" to treat solar lentigo spots on the hands.
研究概览
简要总结
This study evaluates the performance of new technology "CRYOTHERAPY MAINS ET DECOLLETE" against a classic cryotherapy "Nitrogen Liquid " to treat solar lentigines.
The hands and the neckline will be randomised, either left or right side and treated by two cryotherapy devices:
- CRYOTHERAPY MAINS ET DECOLLETE is the device under evaluation.
- Liquid nitrogen is a comparator device.
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
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Phototype II to IV
- •Presenting solar lentigos on both hands and neck, diameter ≤ 6mm
- •Accepting not to expose the body to sunlight or artificial UV rays during the study
- •Affiliate to a health insurance plan
- •Having undergone a general clinical examination attesting to his / her ability to participate in the study
- •Having given written consent
排除标准
- •Having carried out aesthetic care (exfoliants, scrubs or self-tanning, manicure, hand care, UV ...) in the month before the start of the study, at the level of the hands and/or neckline.
- •Having applied a depigmenting product in the month preceding the start of the study, at the level of the hands and/or neckline.
- •Having carried out aesthetic care at a dermatologist (laser, IPL, peeling, depigmenting creams, cryotherapy ...), at the level of the hands and/or neckline, during the last six months
- •Dermatosis, autoimmune disease (vitiligo), systemic, chronic or acute disease, or any other disease that may interfere with the treatment or influence the results of the study (people with diabetes, circulatory problems, cold allergies, With Raynaud's syndrome ...)
- •Receiving general or local treatment (corticosteroids ...) likely to interfere with the evaluation of the studied parameters.
- •Participating in another study or being in an exclusion period from a previous study
- •Being incapable of following the requirements of the protocol
- •Person protected by law
- •Unable to read and write French
- •Pregnant woman or woman wishing to be pregnant during the study, or during breastfeeding period
- •Women of childbearing age who do not have contraception
结局指标
主要结局
Performance assessment of new cryotherapy device "CRYOTHERAPY MAIN ET DECOLLETE" to treat solar lentigo spots on the hands.
时间窗: 8 weeks
Evaluation of CRYOBEAUTY MAINS's performance Hexsel scoring: 1. \> Very significant clearance (about 90%); only minor evidence of hyper pigmentation remains 2. \> Significant improvement (about 75%); some signs of hyper pigmentation remains 3. \> Intermediate between marked and slight improvement; about 50% improvement in the appearance of hyper pigmentation 4. \> Some improvement (about 25%); however, significant evidence of hyper pigmentation remains 5. \> Hyperpigmentation has not changed since baseline 6. \> Worse (hyperpigmentation is worse than at baseline)
次要结局
- Incidence of Treatment-Emergent Adverse Events(8 weeks)
- Assessment of ergonomic and device's readiness(0 weeks)
- Assessment of volunteers feeling (QoL)(0 weeks)
- Pain assessment(0 weeks)
- Evolution of spot's colour(8 weeks)
- Performance assessment of CRYOBEAUTY HANDS AND DECOLLETE on the spots of the neckline.(8 weeks)