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

Primary Purpose

Solar Lentigo

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
CRYOBEAUTY MAINS
Sponsored by
Cryobeauty
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Solar Lentigo focused on measuring Solar Lentigo, Cryotherapy, Difluoroethane

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cpcad Nice Hôpital Archet 2

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

CRYOBEAUTY MAINS

Control

Arm Description

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

The non randomized hand is not teated.

Outcomes

Primary Outcome Measures

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 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 Outcome Measures

Evaluation of solar lentigines numbers
Counting by enumeration of spots
Evaluation of solar lentigines numbers
Counting by enumeration of spots
Evaluation of solar lentigines numbers
Counting by enumeration of spots
Evaluation of solar lentigines colors
Colors assessment: by using Mexameter® MX 18
Evaluation of solar lentigines colors
Colors assessment: by using Mexameter® MX 18
Evaluation of solar lentigines colors
Colors assessment: by using Mexameter® MX 18
Assessment of pain intensity
VAS
Complication and adverse events rate
Any complications or adverse events related or not to the treatment will be collected and evaluated.
Complication and adverse events rate
Any complications or adverse events related or not to the treatment will be collected and evaluated.
Complication and adverse events rate
Any complications or adverse events related or not to the treatment will be collected and evaluated.
Assessment of ergonomic and device's readiness
Ergonomic and device's readiness questionnaire : 6 QCM questions are given to the participants
Assessment of volunteers feeling (QoL)
MelasQoL (Melasma. Quality of Life Scale)
Assessment of volunteers feeling (QoL)
MelasQoL (Melasma. Quality of Life Scale)
Assessment of volunteers feeling (QoL)
MelasQoL (Melasma. Quality of Life Scale)
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 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)
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 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)

Full Information

First Posted
May 3, 2017
Last Updated
September 11, 2017
Sponsor
Cryobeauty
Collaborators
CEISO
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1. Study Identification

Unique Protocol Identification Number
NCT03157427
Brief Title
Clinical Evaluation of the Performance of a Difluoroethane-based Cyto-selective Cryotherapy to Treat Dark Spots on the Hand in 30 Volunteers.
Acronym
CBT
Official Title
Clinical Evaluation of the Performance of a Difluoroethane-based Cyto-selective Cryotherapy to Treat Dark Spots on the Hand in 30 Volunteers.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
June 21, 2017 (Actual)
Primary Completion Date
September 12, 2017 (Actual)
Study Completion Date
September 12, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cryobeauty
Collaborators
CEISO

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solar Lentigo
Keywords
Solar Lentigo, Cryotherapy, Difluoroethane

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be treated on the randomized hand, the other hand is the comparator/control. Comparison between the treated hand and the control hand will be performed.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CRYOBEAUTY MAINS
Arm Type
Experimental
Arm Description
Cryotherapy medical device designed to treat solar lentigo on the randomized hand.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The non randomized hand is not teated.
Intervention Type
Device
Intervention Name(s)
CRYOBEAUTY MAINS
Intervention Description
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 Outcome Measure Information:
Title
Evaluation of CRYOBEAUTY MAINS's performance
Description
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)
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Evaluation of solar lentigines numbers
Description
Counting by enumeration of spots
Time Frame
0 week : same-day following the CRYOBEAUTY MAINS treatment
Title
Evaluation of solar lentigines numbers
Description
Counting by enumeration of spots
Time Frame
4 weeks
Title
Evaluation of solar lentigines numbers
Description
Counting by enumeration of spots
Time Frame
8 weeks
Title
Evaluation of solar lentigines colors
Description
Colors assessment: by using Mexameter® MX 18
Time Frame
0 week : same-day following the CRYOBEAUTY MAINS treatment
Title
Evaluation of solar lentigines colors
Description
Colors assessment: by using Mexameter® MX 18
Time Frame
4 weeks
Title
Evaluation of solar lentigines colors
Description
Colors assessment: by using Mexameter® MX 18
Time Frame
8 weeks
Title
Assessment of pain intensity
Description
VAS
Time Frame
0 week : same-day following the CRYOBEAUTY MAINS treatment
Title
Complication and adverse events rate
Description
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
Title
Complication and adverse events rate
Description
Any complications or adverse events related or not to the treatment will be collected and evaluated.
Time Frame
4 weeks
Title
Complication and adverse events rate
Description
Any complications or adverse events related or not to the treatment will be collected and evaluated.
Time Frame
8 weeks
Title
Assessment of ergonomic and device's readiness
Description
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
Title
Assessment of volunteers feeling (QoL)
Description
MelasQoL (Melasma. Quality of Life Scale)
Time Frame
0 week : same-day following the CRYOBEAUTY MAINS treatment
Title
Assessment of volunteers feeling (QoL)
Description
MelasQoL (Melasma. Quality of Life Scale)
Time Frame
4 weeks
Title
Assessment of volunteers feeling (QoL)
Description
MelasQoL (Melasma. Quality of Life Scale)
Time Frame
8 weeks
Title
Evaluation of CRYOBEAUTY MAINS's performance
Description
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)
Time Frame
0 week : same-day following the CRYOBEAUTY MAINS treatment
Title
Evaluation of CRYOBEAUTY MAINS's performance
Description
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)
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Queille-Roussel, MD
Organizational Affiliation
CPCAD Nice
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cpcad Nice Hôpital Archet 2
City
Nice
ZIP/Postal Code
06200
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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