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

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

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.

Study Overview

• Status: Completed
• Conditions: Solar Lentigo
• Intervention / Treatment: Device: CRYOBEAUTY MAINS ET DECOLLETE; Device: Liquid nitrogen

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

Contacts and Locations

Study Locations

• France
  • Nice, France
    • CPCAD

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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.
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; 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.; Other Names: Azote médical liquide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	8 weeks
Evolution of spot's colour	Colours assessment: by using Mexameter® MX 18	0 weeks
Evolution of spot's colour	Colours assessment: by using Mexameter® MX 18	4 weeks
Evolution of spot's colour	Colours assessment: by using Mexameter® MX 18	8 weeks
Pain assessment	VAS	0 weeks
Incidence of Treatment-Emergent Adverse Events	Adverse events [Safety and Tolerability]	4 weeks
Incidence of Treatment-Emergent Adverse Events	Adverse events [Safety and Tolerability]	8 weeks
Assessment of ergonomic and device's readiness	Ergonomic and device's readiness questionnaire: 6 QCM questions are given to the participants	0 weeks
Assessment of volunteers feeling (QoL)	MelasQoL (Melasma. Quality of Life Scale)	0 weeks

Collaborators and Investigators

• Sponsor: Cryobeauty
• Collaborators: CEISO
• Investigators: Principal Investigator: Catherine Queille-Roussel, MD, Centre de Pharmacologie Clinique Applique a la Dermatologie

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 25, 2017
• Primary Completion (ACTUAL): December 22, 2017
• Study Completion (ACTUAL): December 22, 2017

Study Registration Dates

• First Submitted: July 20, 2017
• First Submitted That Met QC Criteria: July 20, 2017
• First Posted (ACTUAL): July 21, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 4, 2018
• Last Update Submitted That Met QC Criteria: January 3, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Hyperpigmentation; Pigmentation Disorders; Melanosis; Lentigo
• Other Study ID Numbers: 2017-A02179-44

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• 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