Clinical Evaluation of the Performance of a Difluoroethane-based Cyto-selective Cryotherapy to Treat Dark Spots on the Hand in 30 Volunteers.

Study Overview
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Brief Summary
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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).

Official Title
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Clinical Evaluation of the Performance of a Difluoroethane-based Cyto-selective Cryotherapy to Treat Dark Spots on the Hand in 30 Volunteers.

Conditions
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Solar Lentigo

Intervention / Treatment
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* Device: CRYOBEAUTY MAINS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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.

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
Interventional Model Description: Patients will be treated on the randomized hand, the other hand is the comparator/control. Comparison between the treated hand and the control hand will be performed.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CRYOBEAUTY MAINS<br>Cryotherapy medical device designed to treat solar lentigo on the randomized hand. | Device: CRYOBEAUTY MAINS<br>* CYOBEAUTY MAINS diffuses Difluoroethane gas to the skin. The administration of the cryogenic gas is temperature controlled, accurate and contactless (by means of a spray nozzle), in small quantity (<1g) and during a predetermined short duration (3 seconds)<br>|
| No Intervention: Control<br>The non randomized hand is not teated. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 evidence 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 |
| --- | --- | --- |
| Evaluation of solar lentigines numbers | Counting by enumeration of spots | 0 week : same-day following the CRYOBEAUTY MAINS treatment | 
| Evaluation of solar lentigines numbers | Counting by enumeration of spots | 4 weeks | 
| Evaluation of solar lentigines numbers | Counting by enumeration of spots | 8 weeks | 
| Evaluation of solar lentigines colors | Colors assessment: by using Mexameter® MX 18 | 0 week : same-day following the CRYOBEAUTY MAINS treatment | 
| Evaluation of solar lentigines colors | Colors assessment: by using Mexameter® MX 18 | 4 weeks | 
| Evaluation of solar lentigines colors | Colors assessment: by using Mexameter® MX 18 | 8 weeks | 
| Assessment of pain intensity | VAS | 0 week : same-day following the CRYOBEAUTY MAINS treatment | 
| Complication and adverse events rate | Any complications or adverse events related or not to the treatment will be collected and evaluated. | 0 week : same-day following the CRYOBEAUTY MAINS treatment | 
| Complication and adverse events rate | Any complications or adverse events related or not to the treatment will be collected and evaluated. | 4 weeks | 
| Complication and adverse events rate | Any complications or adverse events related or not to the treatment will be collected and evaluated. | 8 weeks | 
| Assessment of ergonomic and device's readiness | Ergonomic and device's readiness questionnaire : 6 QCM questions are given to the participants | 0 week : same-day following the CRYOBEAUTY MAINS treatment | 
| Assessment of volunteers feeling (QoL) | MelasQoL (Melasma. Quality of Life Scale) | 0 week : same-day following the CRYOBEAUTY MAINS treatment | 
| Assessment of volunteers feeling (QoL) | MelasQoL (Melasma. Quality of Life Scale) | 4 weeks | 
| Assessment of volunteers feeling (QoL) | MelasQoL (Melasma. Quality of Life Scale) | 8 weeks | 
| 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 evidence 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) | 0 week : same-day following the CRYOBEAUTY MAINS treatment | 
| 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 evidence 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) | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Solar Lentigo, Cryotherapy, Difluoroethane