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

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: Completed
• Conditions: Solar Lentigo
• Intervention / Treatment: Device: CRYOBEAUTY MAINS

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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)	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of solar lentigines numbers	Counting by enumeration of spots	0 week : same-day following the CRYOBEAUTY MAINS treatment
Evaluation of solar lentigines numbers	Counting by enumeration of spots	4 weeks
Evaluation of solar lentigines numbers	Counting by enumeration of spots	8 weeks
Evaluation of solar lentigines colors	Colors assessment: by using Mexameter® MX 18	0 week : same-day following the CRYOBEAUTY MAINS treatment
Evaluation of solar lentigines colors	Colors assessment: by using Mexameter® MX 18	4 weeks
Evaluation of solar lentigines colors	Colors assessment: by using Mexameter® MX 18	8 weeks
Assessment of pain intensity	VAS	0 week : same-day following the CRYOBEAUTY MAINS treatment
Complication and adverse events rate	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	Any complications or adverse events related or not to the treatment will be collected and evaluated.	4 weeks
Complication and adverse events rate	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	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)	MelasQoL (Melasma. Quality of Life Scale)	0 week : same-day following the CRYOBEAUTY MAINS treatment
Assessment of volunteers feeling (QoL)	MelasQoL (Melasma. Quality of Life Scale)	4 weeks
Assessment of volunteers feeling (QoL)	MelasQoL (Melasma. Quality of Life Scale)	8 weeks
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)	0 week : same-day following the CRYOBEAUTY MAINS treatment
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)	4 weeks

Collaborators and Investigators

• Sponsor: Cryobeauty
• Collaborators: CEISO
• Investigators: Principal Investigator: Catherine Queille-Roussel, MD, CPCAD Nice

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2017
• Primary Completion (Actual): September 12, 2017
• Study Completion (Actual): September 12, 2017

Study Registration Dates

• First Submitted: May 3, 2017
• First Submitted That Met QC Criteria: May 15, 2017
• First Posted (Actual): May 17, 2017

Study Record Updates

• Last Update Posted (Actual): September 12, 2017
• Last Update Submitted That Met QC Criteria: September 11, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Solar Lentigo, Cryotherapy, Difluoroethane
• Additional Relevant MeSH Terms: Skin Diseases; Hyperpigmentation; Pigmentation Disorders; Melanosis; Lentigo
• Other Study ID 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