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Completed

NCT Number: NCT03225729

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

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.

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Key information

Conditions

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CPCAD

Nice, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Other names: Azote médical liquide

Primary outcomes

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

    Time frame: 8 weeks

    Evaluation of CRYOBEAUTY MAINS's performance

    Hexsel scoring:

    • > Very significant clearance (about 90%); only minor evidence of hyper pigmentation remains
    • > Significant improvement (about 75%); some signs of hyper pigmentation remains
    • > Intermediate between marked and slight improvement; about 50% improvement in the appearance of hyper pigmentation
    • > Some improvement (about 25%); however, significant evidence of hyper pigmentation remains
    • > Hyperpigmentation has not changed since baseline
    • > Worse (hyperpigmentation is worse than at baseline)

Secondary outcomes

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

    Time frame: 8 weeks

    Evaluation of CRYOBEAUTY MAINS's performance

    Hexsel scoring:

    • > Very significant clearance (about 90%); only minor evidence of hyper pigmentation remains
    • > Significant improvement (about 75%); some signs of hyper pigmentation remains
    • > Intermediate between marked and slight improvement; about 50% improvement in the appearance of hyper pigmentation
    • > Some improvement (about 25%); however, significant evidence of hyper pigmentation remains
    • > Hyperpigmentation has not changed since baseline
    • > Worse (hyperpigmentation is worse than at baseline)
  2. Evolution of spot's colour

    Time frame: 0 weeks

    Colours assessment: by using Mexameter® MX 18

  3. Evolution of spot's colour

    Time frame: 4 weeks

    Colours assessment: by using Mexameter® MX 18

  4. Evolution of spot's colour

    Time frame: 8 weeks

    Colours assessment: by using Mexameter® MX 18

  5. Pain assessment

    Time frame: 0 weeks

    VAS

  6. Incidence of Treatment-Emergent Adverse Events

    Time frame: 4 weeks

    Adverse events [Safety and Tolerability]

  7. Incidence of Treatment-Emergent Adverse Events

    Time frame: 8 weeks

    Adverse events [Safety and Tolerability]

  8. Assessment of ergonomic and device's readiness

    Time frame: 0 weeks

    Ergonomic and device's readiness questionnaire: 6 QCM questions are given to the participants

  9. Assessment of volunteers feeling (QoL)

    Time frame: 0 weeks

    MelasQoL (Melasma. Quality of Life Scale)

Sponsors and collaborators

Lead sponsor

Cryobeauty

Industry

Collaborators

  • CEISO

Registry information

Official study title

Prospective Clinical Trial to Assess the Performance of a Cyto-selective Cryotherapye "CRYOBEAUTY MAINS ET DECOLLETE" Compared With Liquid Nitrogen Cryotherapy in the Treatment of Solar Lentigines in 30 Patients

Acronym: CBT-EC2

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jul 21, 2017
Registry last updated
Jan 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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