Evaluation of the Tolerance and the Mode of Administration of Cyto-selective Difluoroethane-based Cryotherapy in the Treatment of Brown Spots
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- PERFORMANCE : Skin color evaluation
研究概览
简要总结
CRYO (N° 21D588A0001) study aims to evaluate the tolerance and adjust the mode of administration of a cyto-selective difluoroethane-based cryotherapy in the treatment of brown spots.
The study is a proof of concept on a small panel of subjects and has been designed to be interventional, monocentric, randomized and double blind.
The study will include three device prototypes and a CE marked device (trademark URGO CRYOBEAUTY MAINS-BRAS-JAMBES) used as reference.
详细描述
Solar lentigo is a harmless patch of darkened skin. It results from exposure to ultraviolet (UV) radiation, which causes local proliferation of melanocytes and accumulation of melanin within the skin cells (keratinocytes). Solar lentigos or lentigines are very common, especially in people over the age of 40 years.
CRYONOVE PHARMA develops and manufactures cryotherapy-based devices to improve skin appearance and treat lentigo spot. The mode of action of CRYONOVE devices consists to "provoke a selective cell death (melanocyte & melanosome) by thermic shock induced by a rapid decrease in skin temperature via the diffusion of difluoroethane gas to the skin".
In this proof of concept study, the sponsor aims to assess the tolerance and the admininistration mode of cryogenic spray which could be used for lentigo treatment on the face.
The study is exploratory, interventional, monocentric, randomized and double blind.
Three prototypes of devices for face are compared to a CE marking device (trademark URGO CRYOBEAUTY MAINS-BRAS-JAMBES) used as reference.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Each spot will be treated by a defined prototype / device (always the same prototype / device on the same spot all along the study - one unique prototype/device per spot). The application order of the different device prototypes (810A-v1), (810B-v1), (810C-v1) will be defined by randomization except for CNV Body that will always be applied last.
Each prototype will be identified by a 3 characters internal code (00-x) corresponding to the treated spot with "00" corresponding to the subject number from 01 to 12 and "x" corresponding to the selected spot from A to D.
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
- 是
入选标准
- •Female or male.
- •Ages 30 to
- •Phototype II et III according to Fitzpatrick scale
- •Featuring brown spots (solar lentigos) on the face ≥ 3 mm to ≤ 6 mm in diameter (at least 4 spots per subject).
- •Agreeing not to be exposed to the sun (or artificial UV) during the study.
- •Informed, having undergone a general clinical examination attesting to his ability to participate in the study.
- •Having given written consent for participation in the study.
- •No suspicion of carcinoma after investigation by a Dermatologist.
排除标准
- •Having performed cosmetic treatments (exfoliants, scrubs or self-tanners, manicures, facials, UV ...) in the month before the start of the study, at the level of the face.
- •Having applied a depraving product in the month prior to the start of the study, at the level of the face.
- •Having performed cosmetic treatments in a dermatologist (laser, IPL, peeling, creams, cryotherapy ...), at the level of the face in the last 6 months.
- •With dermatosis, autoimmune disease, systemic, chronic or acute disease, or any other pathology that may interfere with treatment or influence the results of the study (people with diabetes or circulatory problems, allergic to cold, Raynaud's syndrome...).
- •Receiving treatment by general or local (dermo corticoids, corticosteroids, diuretics ...) likely to interfere with the evaluation of the parameter studied.
- •Participating in another study or being excluded from a previous study.
- •Unable to follow the requirements of the protocol.
- •Vulnerable: whose ability or freedom to give or refuse consent is limited.
- •Major protected by law (tutorship, curatorship, safeguarding justice...).
- •People unable to read and write Ukrainian language.
- •Unable to be contacted urgently over the phone.
- •For female subjects:
- •Pregnant woman (or wishing to be pregnant during study) or while breastfeeding.
- •A woman, who does not use effective methods of contraception.
结局指标
主要结局
PERFORMANCE : Skin color evaluation
时间窗: Day 56
Clinical evaluation of each treated lentigo spot and spotless area (one on face and far from a lentigo spot) will be performed in blinded conditions by a trained assessor by scoring using L'OREAL ColorChart\* in standardized position and lighting. The score delta between Day 56 post treatment and D0 pre-treatment will be calculated. The expected results is a score delta (D56-D0) \< -1 for lighteness of lentigo spot. \*Jean de Rigal, Marie-Laurence Abella, Franck Giron, Laurence Caisey, Marc André Lefebvre - Development and validation of a new Skin Color Chart® - Skin Research1 Technology, January 2007.
TOLERABILITY : Post-treatment pain assessement
时间窗: Day 0 (Time1 defined as 15 minutes post-treatment)
The pain of the treatment will be assessed by the VAS (Visual Analogue Scale). Pain intensity is measured in millimeters by the distance from the position of the mark to the "no pain" extremity. Based on the distribution of pain VAS scores in postoperative patients, the following bounds were recommended for the assessment of this scale: no pain (0-4mm), mild pain (5-44mm), moderate pain (45-74 mm) and severe pain (75- 100 mm). The expected outcomes are pain score \< 44 mm (mild pain) for CNV Body and score \< 4 mm (no pain) for each prototype.
TOLERABILITY : Appearance of edemas, blisters, bubbles or scars.
时间窗: Day 56
Clinical evaluation of treated lentigo spot will be performed by a Dermatologist by scoring with standardized position and lighting. The evaluation will be performed visualy on the selected lentigo spots and surrounded spotless skin area around the spot skin. A scale in 5 points (0 to 4) will be used : 0=none; 1=very mild; 2=mild; 3=moderate; 4=severe. The expected score is \< 1.
次要结局
- PERFORMANCE: Standardized photographs by C-Cube® acquisition(Day 56)
- TOLERABILITY : Hypopigmentation(Day 0/Time 0 to Day 56)
- TOLERABILITY : Hyperpigmentation(Day 0/Time 0 to Day 56)
- TOLERABILITY : Skin sensation(Day 0/Time 0 to Day 56)
- EFFICACY: Self-assessment of the subject(From Day 2 to Day 42)
- TOLERABILITY: other expected events(Day 0/Time 0 to Day 56)
- TOLERABILITY : Erythema(Day 0/Time 0 to Day 56)