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| Name | Class |
|---|---|
| CEISO | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CRYOBEAUTY MAINS | Experimental | Cryotherapy medical device designed to treat solar lentigo on the randomized hand. |
|
| Control | No Intervention | The non randomized hand is not teated. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CRYOBEAUTY MAINS | Device | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of CRYOBEAUTY MAINS's performance | Hexsel scoring:
| 8 weeks |
| 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 |
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Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Catherine Queille-Roussel, MD | CPCAD Nice | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cpcad Nice Hôpital Archet 2 | Nice | 06200 | France |
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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.
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|
| 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:
| 0 week : same-day following the CRYOBEAUTY MAINS treatment |
| Evaluation of CRYOBEAUTY MAINS's performance | Hexsel scoring:
| 4 weeks |