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Completed

NCT Number: NCT03157427

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

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).

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Key information

Conditions

Solar Lentigo

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cpcad Nice Hôpital Archet 2

Nice, 06200, 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
  • 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.

Non inclusion Criteria:

  • 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.

Treatment and study plan

CRYOBEAUTY MAINS

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)

Primary outcomes

  1. Evaluation of CRYOBEAUTY MAINS's performance

    Time frame: 8 weeks

    Hexsel scoring:

    • > Very significant clearance (about 90%); only minor evidence of hyper pigmentation remains
    • > Significant improvement (about 75%); some evidence 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. Evaluation of solar lentigines numbers

    Time frame: 0 week : same-day following the CRYOBEAUTY MAINS treatment

    Counting by enumeration of spots

  2. Evaluation of solar lentigines numbers

    Time frame: 4 weeks

    Counting by enumeration of spots

  3. Evaluation of solar lentigines numbers

    Time frame: 8 weeks

    Counting by enumeration of spots

  4. Evaluation of solar lentigines colors

    Time frame: 0 week : same-day following the CRYOBEAUTY MAINS treatment

    Colors assessment: by using Mexameter® MX 18

  5. Evaluation of solar lentigines colors

    Time frame: 4 weeks

    Colors assessment: by using Mexameter® MX 18

  6. Evaluation of solar lentigines colors

    Time frame: 8 weeks

    Colors assessment: by using Mexameter® MX 18

  7. Assessment of pain intensity

    Time frame: 0 week : same-day following the CRYOBEAUTY MAINS treatment

    VAS

  8. Complication and adverse events rate

    Time frame: 0 week : same-day following the CRYOBEAUTY MAINS treatment

    Any complications or adverse events related or not to the treatment will be collected and evaluated.

  9. Complication and adverse events rate

    Time frame: 4 weeks

    Any complications or adverse events related or not to the treatment will be collected and evaluated.

  10. Complication and adverse events rate

    Time frame: 8 weeks

    Any complications or adverse events related or not to the treatment will be collected and evaluated.

  11. Assessment of ergonomic and device's readiness

    Time frame: 0 week : same-day following the CRYOBEAUTY MAINS treatment

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

  12. Assessment of volunteers feeling (QoL)

    Time frame: 0 week : same-day following the CRYOBEAUTY MAINS treatment

    MelasQoL (Melasma. Quality of Life Scale)

  13. Assessment of volunteers feeling (QoL)

    Time frame: 4 weeks

    MelasQoL (Melasma. Quality of Life Scale)

  14. Assessment of volunteers feeling (QoL)

    Time frame: 8 weeks

    MelasQoL (Melasma. Quality of Life Scale)

  15. Evaluation of CRYOBEAUTY MAINS's performance

    Time frame: 0 week : same-day following the CRYOBEAUTY MAINS treatment

    Hexsel scoring:

    • > Very significant clearance (about 90%); only minor evidence of hyper pigmentation remains
    • > Significant improvement (about 75%); some evidence 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)

  16. Evaluation of CRYOBEAUTY MAINS's performance

    Time frame: 4 weeks

    Hexsel scoring:

    • > Very significant clearance (about 90%); only minor evidence of hyper pigmentation remains
    • > Significant improvement (about 75%); some evidence 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)

Sponsors and collaborators

Lead sponsor

Cryobeauty

Industry

Collaborators

  • CEISO

Registry information

Acronym: CBT

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 17, 2017
Registry last updated
Sep 12, 2017

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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