Assessment of CRYOBEAUTY MAINS ET DECOLLETE Versus Liquid Nitrogen Cryotherapy, in the Treatment of Solar Lentigines

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Solar Lentigo

Intervention / Treatment
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* Device: CRYOBEAUTY MAINS ET DECOLLETE
* Device: Liquid nitrogen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CRYOBEAUTY MAINS ET DECOLLETE<br>CRYOBEAUTY MAINS ET DECOLLETE is a new technology conceived to treat solar lentigo. One side left, or right of neckline and/or hands is attributed to this device according to randomization protocol. | Device: CRYOBEAUTY MAINS ET DECOLLETE<br>* 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.<br>|
| Active Comparator: Liquid nitrogen<br>Liquid nitrogen is a classic cryotherapy device. One side, either left or right of neckline and/or hands are attributed to this device according to randomization protocol. | Device: Liquid nitrogen<br>* 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.<br>* Other names: Azote médical liquide;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance assessment of new cryotherapy device CRYOTHERAPY MAIN ET DECOLLETE to treat solar lentigo spots on the hands. | Evaluation of CRYOBEAUTY MAINS's performance Hexsel scoring: > Very significant clearance (about 90%); only minor evidence of hyper pigmentation remains > Significant improvement (about 75%); some signs of hyper pigmentation remains > Intermediate between marked and slight improvement; about 50% improvement in the appearance of hyper pigmentation > Some improvement (about 25%); however, significant evidence of hyper pigmentation remains > Hyperpigmentation has not changed since baseline > Worse (hyperpigmentation is worse than at baseline) | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance assessment of CRYOBEAUTY HANDS AND DECOLLETE on the spots of the neckline. | Evaluation of CRYOBEAUTY MAINS's performance Hexsel scoring: > Very significant clearance (about 90%); only minor evidence of hyper pigmentation remains > Significant improvement (about 75%); some signs of hyper pigmentation remains > Intermediate between marked and slight improvement; about 50% improvement in the appearance of hyper pigmentation > Some improvement (about 25%); however, significant evidence of hyper pigmentation remains > Hyperpigmentation has not changed since baseline > Worse (hyperpigmentation is worse than at baseline) | 8 weeks | 
| Evolution of spot's colour | Colours assessment: by using Mexameter® MX 18 | 0 weeks | 
| Evolution of spot's colour | Colours assessment: by using Mexameter® MX 18 | 4 weeks | 
| Evolution of spot's colour | Colours assessment: by using Mexameter® MX 18 | 8 weeks | 
| Pain assessment | VAS | 0 weeks | 
| Incidence of Treatment-Emergent Adverse Events | Adverse events [Safety and Tolerability] | 4 weeks | 
| Incidence of Treatment-Emergent Adverse Events | Adverse events [Safety and Tolerability] | 8 weeks | 
| Assessment of ergonomic and device's readiness | Ergonomic and device's readiness questionnaire: 6 QCM questions are given to the participants | 0 weeks | 
| Assessment of volunteers feeling (QoL) | MelasQoL (Melasma. Quality of Life Scale) | 0 weeks |