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Assessment of CRYOBEAUTY MAINS ET DECOLLETE Versus Liquid Nitrogen Cryotherapy, in the Treatment of Solar Lentigines (CBT-EC2)

Primary Purpose

Solar Lentigo

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

About this trial

This is an interventional treatment trial for Solar Lentigo

Eligibility Criteria

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

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:

  • 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

Sites / Locations

  • CPCAD

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CRYOBEAUTY MAINS ET DECOLLETE

Liquid nitrogen

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Performance assessment of CRYOBEAUTY HANDS AND DECOLLETE on the spots of the neckline.
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 signs 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)
Evolution of spot's colour
Colours assessment: by using Mexameter® MX 18
Evolution of spot's colour
Colours assessment: by using Mexameter® MX 18
Evolution of spot's colour
Colours assessment: by using Mexameter® MX 18
Pain assessment
VAS
Incidence of Treatment-Emergent Adverse Events
Adverse events [Safety and Tolerability]
Incidence of Treatment-Emergent Adverse Events
Adverse events [Safety and Tolerability]
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)

Full Information

First Posted
July 20, 2017
Last Updated
January 3, 2018
Sponsor
Cryobeauty
Collaborators
CEISO
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1. Study Identification

Unique Protocol Identification Number
NCT03225729
Brief Title
Assessment of CRYOBEAUTY MAINS ET DECOLLETE Versus Liquid Nitrogen Cryotherapy, in the Treatment of Solar Lentigines
Acronym
CBT-EC2
Official Title
Prospective Clinical Trial to Assess the Performance of a Cyto-selective Cryotherapye "CRYOBEAUTY MAINS ET DECOLLETE" Compared With Liquid Nitrogen Cryotherapy in the Treatment of Solar Lentigines in 30 Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
October 25, 2017 (Actual)
Primary Completion Date
December 22, 2017 (Actual)
Study Completion Date
December 22, 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
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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: CRYOTHERAPY MAINS ET DECOLLETE is the device under evaluation. Liquid nitrogen is a comparator device.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CRYOBEAUTY MAINS ET DECOLLETE
Arm Type
Experimental
Arm Description
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.
Arm Title
Liquid nitrogen
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
CRYOBEAUTY MAINS ET DECOLLETE
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Liquid nitrogen
Other Intervention Name(s)
Azote médical liquide
Intervention Description
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.
Primary Outcome Measure Information:
Title
Performance assessment of new cryotherapy device "CRYOTHERAPY MAIN ET DECOLLETE" to treat solar lentigo spots on the hands.
Description
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 signs 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
Performance assessment of CRYOBEAUTY HANDS AND DECOLLETE on the spots of the neckline.
Description
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 signs 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
Title
Evolution of spot's colour
Description
Colours assessment: by using Mexameter® MX 18
Time Frame
0 weeks
Title
Evolution of spot's colour
Description
Colours assessment: by using Mexameter® MX 18
Time Frame
4 weeks
Title
Evolution of spot's colour
Description
Colours assessment: by using Mexameter® MX 18
Time Frame
8 weeks
Title
Pain assessment
Description
VAS
Time Frame
0 weeks
Title
Incidence of Treatment-Emergent Adverse Events
Description
Adverse events [Safety and Tolerability]
Time Frame
4 weeks
Title
Incidence of Treatment-Emergent Adverse Events
Description
Adverse events [Safety and Tolerability]
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 weeks
Title
Assessment of volunteers feeling (QoL)
Description
MelasQoL (Melasma. Quality of Life Scale)
Time Frame
0 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 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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Queille-Roussel, MD
Organizational Affiliation
Centre de Pharmacologie Clinique Applique a la Dermatologie
Official's Role
Principal Investigator
Facility Information:
Facility Name
CPCAD
City
Nice
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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