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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
30
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.
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.
CPCAD
Nice, France
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: 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)
Time frame: 8 weeks
Performance assessment of CRYOBEAUTY HANDS AND DECOLLETE on the spots of the neckline.
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)
Time frame: 8 weeks
Evolution of spot's colour
Colours assessment: by using Mexameter® MX 18
Time frame: 0 weeks
Evolution of spot's colour
Colours assessment: by using Mexameter® MX 18
Time frame: 4 weeks
Evolution of spot's colour
Colours assessment: by using Mexameter® MX 18
Time frame: 8 weeks
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Pain assessment
VAS
Time frame: 0 weeks
Incidence of Treatment-Emergent Adverse Events
Adverse events \[Safety and Tolerability\]
Time frame: 4 weeks
Incidence of Treatment-Emergent Adverse Events
Adverse events \[Safety and Tolerability\]
Time frame: 8 weeks
Assessment of ergonomic and device's readiness
Ergonomic and device's readiness questionnaire: 6 QCM questions are given to the participants
Time frame: 0 weeks
Assessment of volunteers feeling (QoL)
MelasQoL (Melasma. Quality of Life Scale)
Time frame: 0 weeks