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

Cryobeauty

Status

Completed

Conditions

Solar Lentigo

Treatments

Device: CRYOBEAUTY MAINS

Study type

Interventional

Funder types

Industry

Identifiers

NCT03157427

2017-A00068-45

Details and patient eligibility

About

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).

Enrollment

30 patients

Sex

All

Ages

30 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.