The goal of this clinical trial is to compare the 2 different prototype of cytoselectivecryotherapy 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 2 prototypes of cyto-selective cryotherapy treatments * the performance of 2 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
DOUBLE
Enrollment
30
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). The prototype is intended to treat pigmented spots of the face (PIH spots and senile and solar lentigos).
SMU - Photobiology Laboratory, Sefako Makgatho Health Sciences University
Pretoria, South Africa
Tolerance
Evaluate the evolution of the scores given by the dermatologist or the participant on the following items : Hyperpigmentation (IGA scale)\* Hypopigmentation Erythema, oedema, micro-bruise, hematoma, dryness, desquamation, fissures / cracks, roughness, crust Skin sensation (tightness, stinging, itching, warm and burning sensations) Day 0: Pain after each treatment (5 min. rest between two treatments) Other unexpected events \*: IGA Scale : Investigator's Global Assessment - 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: [Time Frame: Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 56, Day 70]
Performance (Acquisitions C-cube)
--\> Performance assesment : • Standardized photographs will be taken before the treatment at each visit (C-Cube acquisition without analysis) - illustration only
Time frame: [Time Frame: Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 56, Day 70]
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