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

NCT ID: NCT03157427

Last Updated: 2017-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-21
• Study Completion Date: 2017-09-12

Brief Summary

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).

Conditions

Solar Lentigo

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

CRYOBEAUTY MAINS

Cryotherapy medical device designed to treat solar lentigo on the randomized hand.

Group Type: EXPERIMENTAL

CRYOBEAUTY MAINS

Intervention Type: DEVICE

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)

Control

The non randomized hand is not teated.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

CRYOBEAUTY MAINS

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)

Intervention Type: DEVICE

Eligibility 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.

• 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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CEISO

INDUSTRY

Sponsor Role: collaborator

Cryobeauty

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Catherine Queille-Roussel, MD

Role: PRINCIPAL_INVESTIGATOR

CPCAD Nice

Locations

Cpcad Nice Hôpital Archet 2

Nice, , France

Countries

France

Other Identifiers

2017-A00068-45

Identifier Type: -

Identifier Source: org_study_id