CClinicalTrials.gg
Sign In
CompletedNCT03157427CBTUpdated Sep 12, 2017

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

An interventional study of CRYOBEAUTY MAINS in Solar Lentigo, sponsored by Cryobeauty. Completed at 1 site in France. Open to participants aged 30 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-09-12.

Sponsored by Cryobeauty · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
30 Years to 75 Years
Sex
All
01

Study summary

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).

02

Conditions studied

  • Solar Lentigo

Browse trials for

Keywords

  • Solar Lentigo, Cryotherapy, Difluoroethane
03

Who can participate

Ages eligible
30 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    CRYOBEAUTY MAINS

    Cryotherapy medical device designed to treat solar lentigo on the randomized hand.

    Device: CRYOBEAUTY MAINS

  • No intervention
    Control

    The non randomized hand is not teated.

Interventions

  • DeviceCRYOBEAUTY MAINS

    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)

05

What researchers measure

Primary outcomes

  1. 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 evidence 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)

    Time frame: 8 weeks

Secondary outcomes

  1. Evaluation of solar lentigines numbers

    Counting by enumeration of spots

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

  2. Evaluation of solar lentigines numbers

    Counting by enumeration of spots

    Time frame: 4 weeks

  3. Evaluation of solar lentigines numbers

    Counting by enumeration of spots

    Time frame: 8 weeks

  4. Evaluation of solar lentigines colors

    Colors assessment: by using Mexameter® MX 18

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

  5. Evaluation of solar lentigines colors

    Colors assessment: by using Mexameter® MX 18

    Time frame: 4 weeks

  6. Evaluation of solar lentigines colors

    Colors assessment: by using Mexameter® MX 18

    Time frame: 8 weeks

  7. Assessment of pain intensity

    VAS

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

  8. Complication and adverse events rate

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

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

  9. Complication and adverse events rate

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

    Time frame: 4 weeks

  10. Complication and adverse events rate

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

    Time frame: 8 weeks

  11. Assessment of ergonomic and device's readiness

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

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

  12. Assessment of volunteers feeling (QoL)

    MelasQoL (Melasma. Quality of Life Scale)

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

  13. Assessment of volunteers feeling (QoL)

    MelasQoL (Melasma. Quality of Life Scale)

    Time frame: 4 weeks

  14. Assessment of volunteers feeling (QoL)

    MelasQoL (Melasma. Quality of Life Scale)

    Time frame: 8 weeks

  15. 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 evidence 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)

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

  16. 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 evidence 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)

    Time frame: 4 weeks

06

Study locations

1 site
  • Cpcad Nice Hôpital Archet 2
    Nice, 06200, France
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03157427
Lead sponsor
Cryobeauty
Collaborators
CEISO
Responsible party
Sponsor
First posted
May 17, 2017
Start date
Jun 21, 2017
Primary completion
Sep 12, 2017
Completion
Sep 12, 2017
Last update
Sep 12, 2017

Study contacts

Catherine Queille-Roussel, MD
principal investigator · CPCAD Nice

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Lentigo→

Other studies from this sponsor

Cryobeauty

Start the discussion