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| Name | Class |
|---|---|
| CEISO | INDUSTRY |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CRYOBEAUTY MAINS ET DECOLLETE | Experimental | 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. |
|
| Liquid nitrogen | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CRYOBEAUTY MAINS ET DECOLLETE | Device | 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. |
|
| 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:
| 8 weeks |
| 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:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Catherine Queille-Roussel, MD | Centre de Pharmacologie Clinique Applique a la Dermatologie | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CPCAD | Nice | France |
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| Liquid nitrogen | Device | 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. |
|
|
| 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 |