Solar Lentigo
Conditions
Brief summary
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: 1. CRYOTHERAPY MAINS ET DECOLLETE is the device under evaluation. 2. Liquid nitrogen is a comparator device.
Interventions
DEVICECRYOBEAUTY MAINS ET DECOLLETE
The intervention lasts up to 6.5 s. The device will be applied on spots \<6 mm which are previously selected by the investigator team.
DEVICELiquid nitrogen
The intervention lasts up to 3 s. The liquid is stored in well-isolated recipients. Each patient has his recipient to avoid contamination. The investigator applies on spots \<6 mm a small amount of nitrogen liquid.
Sponsors
CEISO
Cryobeauty
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Performance assessment of new cryotherapy device CRYOTHERAPY MAIN ET DECOLLETE to treat solar lentigo spots on the hands. | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Performance assessment of CRYOBEAUTY HANDS AND DECOLLETE on the spots of the neckline. | 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) |
| Evolution of spot's colour | 0 weeks | Colours assessment: by using Mexameter® MX 18 |
| Pain assessment | 0 weeks | VAS |
| Incidence of Treatment-Emergent Adverse Events | 4 weeks | Adverse events \[Safety and Tolerability\] |
| Assessment of ergonomic and device's readiness | 0 weeks | Ergonomic and device's readiness questionnaire: 6 QCM questions are given to the participants |
| Assessment of volunteers feeling (QoL) | 0 weeks | MelasQoL (Melasma. Quality of Life Scale) |
Countries
France
Outcome results
None listed