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

September 11, 2017 updated by: Cryobeauty
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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nice, France, 06200
        • Cpcad Nice Hôpital Archet 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: CRYOBEAUTY MAINS
Cryotherapy medical device designed to treat solar lentigo on the randomized hand.
Device: CRYOBEAUTY 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)
No Intervention: Control
The non randomized hand is not teated.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Evaluation of CRYOBEAUTY MAINS's performance
Time Frame: 8 weeks

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)
8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Evaluation of solar lentigines numbers
Time Frame: 0 week : same-day following the CRYOBEAUTY MAINS treatment
Counting by enumeration of spots
0 week : same-day following the CRYOBEAUTY MAINS treatment
Evaluation of solar lentigines numbers
Time Frame: 4 weeks
Counting by enumeration of spots
4 weeks
Evaluation of solar lentigines numbers
Time Frame: 8 weeks
Counting by enumeration of spots
8 weeks
Evaluation of solar lentigines colors
Time Frame: 0 week : same-day following the CRYOBEAUTY MAINS treatment
Colors assessment: by using Mexameter® MX 18
0 week : same-day following the CRYOBEAUTY MAINS treatment
Evaluation of solar lentigines colors
Time Frame: 4 weeks
Colors assessment: by using Mexameter® MX 18
4 weeks
Evaluation of solar lentigines colors
Time Frame: 8 weeks
Colors assessment: by using Mexameter® MX 18
8 weeks
Assessment of pain intensity
Time Frame: 0 week : same-day following the CRYOBEAUTY MAINS treatment
VAS
0 week : same-day following the CRYOBEAUTY MAINS treatment
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.
0 week : same-day following the CRYOBEAUTY MAINS treatment
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.
4 weeks
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.
8 weeks
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
0 week : same-day following the CRYOBEAUTY MAINS treatment
Assessment of volunteers feeling (QoL)
Time Frame: 0 week : same-day following the CRYOBEAUTY MAINS treatment
MelasQoL (Melasma. Quality of Life Scale)
0 week : same-day following the CRYOBEAUTY MAINS treatment
Assessment of volunteers feeling (QoL)
Time Frame: 4 weeks
MelasQoL (Melasma. Quality of Life Scale)
4 weeks
Assessment of volunteers feeling (QoL)
Time Frame: 8 weeks
MelasQoL (Melasma. Quality of Life Scale)
8 weeks
Evaluation of CRYOBEAUTY MAINS's performance
Time Frame: 0 week : same-day following the CRYOBEAUTY MAINS treatment

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)
0 week : same-day following the CRYOBEAUTY MAINS treatment
Evaluation of CRYOBEAUTY MAINS's performance
Time Frame: 4 weeks

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)
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cryobeauty

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
CEISO

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Catherine Queille-Roussel, MD, CPCAD Nice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 21, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 12, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 12, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 3, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 17, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 12, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017-A00068-45

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Solar Lentigo

Clinical Trials on CRYOBEAUTY MAINS

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings