Assessment of CRYOBEAUTY MAINS ET DECOLLETE Versus Liquid Nitrogen Cryotherapy, in the Treatment of Solar Lentigines

NCT ID: NCT03225729

Last Updated: 2018-01-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-25
• Study Completion Date: 2017-12-22

Brief Summary

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.

Conditions

Solar Lentigo

Study Design

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

Study Groups

CRYOBEAUTY MAINS ET DECOLLETE

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.

Group Type: EXPERIMENTAL

CRYOBEAUTY MAINS ET DECOLLETE

Intervention Type: DEVICE

The intervention lasts up to 6.5 s. The device will be applied on spots \<6 mm which are previously selected by the investigator team.

Liquid nitrogen

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.

Group Type: ACTIVE_COMPARATOR

Liquid nitrogen

Intervention Type: DEVICE

The intervention lasts up to 3 s. The liquid is stored in well-isolated recipients. Each patient has his recipient to avoid contamination. The investigator applies on spots \<6 mm a small amount of nitrogen liquid.

Interventions

CRYOBEAUTY MAINS ET DECOLLETE

The intervention lasts up to 6.5 s. The device will be applied on spots \<6 mm which are previously selected by the investigator team.

Intervention Type: DEVICE

Liquid nitrogen

The intervention lasts up to 3 s. The liquid is stored in well-isolated recipients. Each patient has his recipient to avoid contamination. The investigator applies on spots \<6 mm a small amount of nitrogen liquid.

Intervention Type: DEVICE

Other Intervention Names

Azote médical liquide

Eligibility Criteria

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

• 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

Centre de Pharmacologie Clinique Applique a la Dermatologie

Locations

CPCAD

Nice, , France

Countries

France

Other Identifiers

2017-A02179-44

Identifier Type: -

Identifier Source: org_study_id