CClinicalTrials.gg
Sign In
CompletedNCT03225729CBT-EC2Updated Jan 4, 2018

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

An interventional study of CRYOBEAUTY MAINS ET DECOLLETE and Liquid nitrogen 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 2018-01-04.

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 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.
02

Conditions studied

  • Solar Lentigo

Browse trials for

03

Who can participate

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

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

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
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 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.

    Device: CRYOBEAUTY MAINS ET DECOLLETE

  • Active comparator
    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.

    Device: Liquid nitrogen

Interventions

  • DeviceCRYOBEAUTY 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.

  • DeviceLiquid 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.

    Also known as: Azote médical liquide

05

What researchers measure

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)

    Time frame: 8 weeks

Secondary outcomes

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

    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)

    Time frame: 8 weeks

  2. Evolution of spot's colour

    Colours assessment: by using Mexameter® MX 18

    Time frame: 0 weeks

  3. Evolution of spot's colour

    Colours assessment: by using Mexameter® MX 18

    Time frame: 4 weeks

  4. Evolution of spot's colour

    Colours assessment: by using Mexameter® MX 18

    Time frame: 8 weeks

  5. Pain assessment

    VAS

    Time frame: 0 weeks

  6. Incidence of Treatment-Emergent Adverse Events

    Adverse events \[Safety and Tolerability\]

    Time frame: 4 weeks

  7. Incidence of Treatment-Emergent Adverse Events

    Adverse events \[Safety and Tolerability\]

    Time frame: 8 weeks

  8. Assessment of ergonomic and device's readiness

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

    Time frame: 0 weeks

  9. Assessment of volunteers feeling (QoL)

    MelasQoL (Melasma. Quality of Life Scale)

    Time frame: 0 weeks

06

Study locations

1 site
  • CPCAD
    Nice, France
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03225729
Lead sponsor
Cryobeauty
Collaborators
CEISO
Responsible party
Sponsor
First posted
Jul 21, 2017
Start date
Oct 25, 2017
Primary completion
Dec 22, 2017
Completion
Dec 22, 2017
Last update
Jan 4, 2018

Study contacts

Catherine Queille-Roussel, MD
principal investigator · Centre de Pharmacologie Clinique Applique a la Dermatologie

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 Jan 2018. 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