The goal of this clinical trial is to compare the 3 different prototype of cyto-selective cryotherapy devices (name of the devices : CRYONOVE) use in brown spots on the face of subject from different ethnicities. The main questions it aims to answer are: * the tolerance of 3 prototypes of cyto-selective cryotherapy treatments * the performance of 3 prototypes of cyto-selective cryotherapy treatments Participants will be treated for each spots with a definied prototype during 6 treatment visits. Researchers will compare the tolerance and performance of the 3 prototypes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
45
The prototype is a variant version from that of a CE marked MD already commercialized (Cryobeauty mains, Cryobeauty Pharma SAS, France) which produces a cryogenic spray sequence (EC14). The prototype is intended to treat pigmented spots of the face (PIH spots and senile and solar lentigos).
The prototype is a variant version from that of a CE marked MD already commercialized (Cryobeauty mains, Cryobeauty Pharma SAS, France) which produces a cryogenic spray sequence (EC05\_1osc). The prototype is intended to treat pigmented spots of the face (PIH spots and senile and solar lentigos).
The prototype is a variant version from that of a CE marked MD already commercialized (Cryobeauty mains, Cryobeauty Pharma SAS, France) which produces a cryogenic spray sequence (EC05\_2osc). The prototype is intended to treat pigmented spots of the face (PIH spots and senile and solar lentigos).
Tolerance
The primary objective of this clinical investigation is to evaluate the tolerance (IGA scale) of 3 prototypes of cyto-selective cryotherapy treatments applied on the brown spots on the face of subject from different ethnicities (Caucasian and melanin-rich skins). A brown spot is defined as solar or senile lentigo (SSL) and post-inflammatory hyperpigmentation (PIH). -\> IGA Scale : Investigator's Global Assessment - 6 points - Scale in 6 points (0 to 5) 0 = clear of hyperpigmentation 1. = almost clear of hyperpigmentation 2. = mild, but noticeable hyperpigmentation 3. = moderate hyperpigmentation (medium brown in quality) 4. = severe hyperpigmentation (dark brown in quality) 5. = very severe hyperpigmentation (very dark brown, almost black in quality)
Time frame: Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 56, Day 70, Day 84
Performance
The secondary objective of this clinical investigation is to evaluate the performance of 3 prototypes of cyto-selective cryotherapy treatments applied on the brown spots on the face of subject from different ethnicities (Caucasian and melanin-rich skins). * Standardized photographs will be taken before the treatment at each visit (C-cube). * Color Chart (color and lightness) only for Caucasian skins.
Time frame: Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 56, Day 70, Day 84
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