Clinical Evaluation of the Performance of a Difluoroethane-based Cyto-selective Cryotherapy to Treat Dark Spots on the Hand in 30 Volunteers.
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
- 2
- 主要终点
- Evaluation of CRYOBEAUTY MAINS's performance
研究概览
简要总结
This study evaluates the performance of "CRYOBEAUTY MAINS", a Cyto-selective Cryotherapy based on Difluoroethane as a treatment of Solar Lentigines in 30 volunteers. Only one application of "CRYOBEAUTY MAINS" in one hand (right or left hand according to the randomization code).
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
- •Subjects having brown spots (solar lentigo) on both hands, diameter ≤ 6 mm (at least 1 spot per hand).
- •Accepting not to expose themselves to the sun (or artificial UV) during the study.
- •Affiliated to a health insurance scheme in accordance with the French law on research involving the human subjects
- •Informed, having undergone a general medical examination attesting to his / her ability to participate in the study.
- •Having given informed written consent for their participation in the study.
- •Non inclusion Criteria:
- •Having carried out aesthetic care (exfoliants, scrubs or self-tanning, manicure, hand care, UV ...) in the month prior to the start of the study, on the hands.
- •Having applied a depigmenting product in the month prior to the start of the study, on the hands.
- •Having carried out aesthetic care at a dermatologist (laser, IPL, peeling, depigmenting creams, cryotherapy ...), on the hands, during the last 6 months.
- •Presenting dermatosis, autoimmune disease, systemic, chronic or acute illness, or any other condition that may interfere with the treatment or influence the results of the study (diabetic, circulatory, cold allergic, Raynaud's syndrome ...)
- •Any general or local treatment (dermocorticoids, corticosteroids, diuretics, etc.) likely to interfere with the evaluation of the parameter studied.
- •Participating in another study or being in an exclusion period from a previous study
- •Being unable to comply to the protocole.
- •Having Received over 4,500 euros compensation for his / her participation in clinical trials in the previous 12 months, including participation in this study.
- •Vulnerable: being unable to give or refuse consent.
- •Protected by the law (guardianship, curatorship, safeguard of justice ...).
- •Unable to write or read in French.
- •Can not be contacted by telephone.
- •For female subjects:
- •Pregnant woman (or wanting to be pregnant during the study) or during breastfeeding.
- •Female not willing to use contraceptives.
排除标准
- 未提供
研究组 & 干预措施
CRYOBEAUTY MAINS
Cryotherapy medical device designed to treat solar lentigo on the randomized hand.
干预措施: CRYOBEAUTY MAINS (Device)
Control
The non randomized hand is not teated.
结局指标
主要结局
Evaluation of CRYOBEAUTY MAINS's performance
时间窗: 8 weeks
Hexsel scoring: 1. \> Very significant clearance (about 90%); only minor evidence of hyper pigmentation remains 2. \> Significant improvement (about 75%); some evidence 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
- Evaluation of solar lentigines colors(8 weeks)
- Assessment of pain intensity(0 week : same-day following the CRYOBEAUTY MAINS treatment)
- Assessment of volunteers feeling (QoL)(8 weeks)
- Evaluation of solar lentigines numbers(8 weeks)
- Complication and adverse events rate(8 weeks)
- Assessment of ergonomic and device's readiness(0 week : same-day following the CRYOBEAUTY MAINS treatment)
- Evaluation of CRYOBEAUTY MAINS's performance(4 weeks)