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

Not Applicable

Completed

• Conditions: Solar Lentigo
• Interventions: Device: CRYOBEAUTY MAINS ET DECOLLETE; Device: Liquid nitrogen

• Registration Number: NCT03225729
• Lead Sponsor: Cryobeauty

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:

1. CRYOTHERAPY MAINS ET DECOLLETE is the device under evaluation.

2. Liquid nitrogen is a comparator device.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-20
• Study First Submitted QC: 2017-07-20
• Study First Posted: 2017-07-21
• Study Start: 2017-10-25
• Primary Completion: 2017-12-22
• Study Completion: 2017-12-22
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-03
• Last Update Posted: 2018-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CRYOBEAUTY MAINS ET DECOLLETE	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.
Liquid nitrogen	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.

Primary Outcome Measures

Name	Time	Method
Performance assessment of new cryotherapy device "CRYOTHERAPY MAIN ET DECOLLETE" to treat solar lentigo spots on the hands.	8 weeks	Evaluation of CRYOBEAUTY MAINS's performance; Hexsel scoring: 1. \> Very significant clearance (about 90%); only minor evidence of hyper pigmentation remains; 2. \> Significant improvement (about 75%); some signs 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)

Secondary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events	8 weeks	Adverse events \[Safety and Tolerability\]
Assessment of ergonomic and device's readiness	0 weeks	Ergonomic and device's readiness questionnaire: 6 QCM questions are given to the participants
Assessment of volunteers feeling (QoL)	0 weeks	MelasQoL (Melasma. Quality of Life Scale)
Pain assessment	0 weeks	VAS
Evolution of spot's colour	8 weeks	Colours assessment: by using Mexameter® MX 18
Performance assessment of CRYOBEAUTY HANDS AND DECOLLETE on the spots of the neckline.	8 weeks	Evaluation of CRYOBEAUTY MAINS's performance; Hexsel scoring: 1. \> Very significant clearance (about 90%); only minor evidence of hyper pigmentation remains; 2. \> Significant improvement (about 75%); some signs 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)

Trial Locations

Locations (1)

CPCAD; 🇫🇷 Nice, France