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

NCT03225729 | Completed

• 1 other identifier: 2017-A02179-44
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Solar Lentigo

Outcome Measures

Primary Outcomes (1)

• Performance assessment of new cryotherapy device "CRYOTHERAPY MAIN ET DECOLLETE" to treat solar lentigo spots on the hands.

  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 signs 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)

  8 weeks

Secondary Outcomes (9)

• Performance assessment of CRYOBEAUTY HANDS AND DECOLLETE on the spots of the neckline.

  8 weeks

• Evolution of spot's colour

  0 weeks

• Evolution of spot's colour

  4 weeks

• Evolution of spot's colour

  8 weeks

• Pain assessment

  0 weeks

Study Arms (2)

CRYOBEAUTY MAINS ET DECOLLETE

EXPERIMENTAL

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.

Device: CRYOBEAUTY MAINS ET DECOLLETE

Liquid nitrogen

ACTIVE COMPARATOR

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.

Device: Liquid nitrogen

Interventions

CRYOBEAUTY MAINS ET DECOLLETE 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.

CRYOBEAUTY MAINS ET DECOLLETE

Liquid nitrogen 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.

Also known as: Azote médical liquide

Liquid nitrogen

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Cryobeauty: lead
• CEISO: collaborator

Study Sites (1)

CPCAD

Nice, France

Location

Study Officials

• Catherine Queille-Roussel, MD

  Centre de Pharmacologie Clinique Applique a la Dermatologie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2017
• First Posted: July 21, 2017
• Study Start: October 25, 2017
• Primary Completion: December 22, 2017
• Study Completion: December 22, 2017
• Last Updated: January 4, 2018

Record last verified: 2018-01

Locations

FR (1)