Assessment of CRYOBEAUTY MAINS ET DECOLLETE Versus Liquid Nitrogen Cryotherapy, in the Treatment of Solar Lentigines (CBT-EC2)

Cryobeauty

Status: Completed

Conditions: Solar Lentigo

Treatments: Device: Liquid nitrogen; Device: CRYOBEAUTY MAINS ET DECOLLETE

Study type: Interventional

Funder types: Industry

Identifiers

NCT03225729

2017-A02179-44

Details and patient eligibility

About

This study evaluates the performance of new technology "CRYOTHERAPY MAINS ET DECOLLETE" against a classic cryotherapy "Nitrogen Liquid " to treat solar lentigines.

The hands and the neckline will be randomised, either left or right side and treated by two cryotherapy devices:

1. CRYOTHERAPY MAINS ET DECOLLETE is the device under evaluation.
2. Liquid nitrogen is a comparator device.

Enrollment: 30 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Phototype II to IV
• Presenting solar lentigos on both hands and neck, diameter ≤ 6mm
• Accepting not to expose the body to sunlight or artificial UV rays during the study
• Affiliate to a health insurance plan
• Having undergone a general clinical examination attesting to his / her ability to participate in the study
• Having given written consent

Exclusion criteria

• Having carried out aesthetic care (exfoliants, scrubs or self-tanning, manicure, hand care, UV ...) in the month before the start of the study, at the level of the hands and/or neckline.
• Having applied a depigmenting product in the month preceding the start of the study, at the level of the hands and/or neckline.
• Having carried out aesthetic care at a dermatologist (laser, IPL, peeling, depigmenting creams, cryotherapy ...), at the level of the hands and/or neckline, during the last six months
• Dermatosis, autoimmune disease (vitiligo), systemic, chronic or acute disease, or any other disease that may interfere with the treatment or influence the results of the study (people with diabetes, circulatory problems, cold allergies, With Raynaud's syndrome ...)
• Receiving general or local treatment (corticosteroids ...) likely to interfere with the evaluation of the studied parameters.
• Participating in another study or being in an exclusion period from a previous study
• Being incapable of following the requirements of the protocol
• Person protected by law
• Unable to read and write French
• Pregnant woman or woman wishing to be pregnant during the study, or during breastfeeding period
• Women of childbearing age who do not have contraception

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

CRYOBEAUTY MAINS ET DECOLLETE

Experimental group

Description:

CRYOBEAUTY MAINS ET DECOLLETE is a new technology conceived to treat solar lentigo. One side left, or right of neckline and/or hands is attributed to this device according to randomization protocol.

Treatment:

Device: CRYOBEAUTY MAINS ET DECOLLETE

Liquid nitrogen

Active Comparator group

Description:

Liquid nitrogen is a classic cryotherapy device. One side, either left or right of neckline and/or hands are attributed to this device according to randomization protocol.

Treatment:

Device: Liquid nitrogen