Clinical Evaluation of the Performance of a Difluoroethane-based Cyto-selective Cryotherapy to Treat Dark Spots on the Hand in 30 Volunteers.

Cryobeauty30 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Solar Lentigo

Interventions

CRYOBEAUTY MAINSDEVICE

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)

Eligibility

Sex: ALLMin age: 30 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Phototype II to IV * Subjects having brown spots (solar lentigo) on both hands, diameter ≤ 6 mm (at least 1 spot per hand). * Accepting not to expose themselves to the sun (or artificial UV) during the study. * Affiliated to a health insurance scheme in accordance with the French law on research involving the human subjects * Informed, having undergone a general medical examination attesting to his / her ability to participate in the study. * Having given informed written consent for their participation in the study. 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: * Pregnant woman (or wanting to be pregnant during the study) or during breastfeeding. * Female not willing to use contraceptives.

Locations (1)

Cpcad Nice Hôpital Archet 2

Nice, France

Outcomes

Primary Outcomes

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 evidence 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

Secondary Outcomes

Evaluation of solar lentigines numbers

Counting by enumeration of spots

Time frame: 0 week : same-day following the CRYOBEAUTY MAINS treatment

Evaluation of solar lentigines numbers

Counting by enumeration of spots

Time frame: 4 weeks

Evaluation of solar lentigines numbers

Counting by enumeration of spots

Time frame: 8 weeks

Evaluation of solar lentigines colors

Colors assessment: by using Mexameter® MX 18

Time frame: 0 week : same-day following the CRYOBEAUTY MAINS treatment

Evaluation of solar lentigines colors

Colors assessment: by using Mexameter® MX 18

Time frame: 4 weeks

Evaluation of solar lentigines colors

Colors assessment: by using Mexameter® MX 18

Time frame: 8 weeks

Data from ClinicalTrials.gov

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