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

Solar Lentigo Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03225729
• Other study ID #: 2017-A02179-44
• Status: Completed
• Phase: N/A
• First received: July 20, 2017
• Last updated: January 3, 2018
• Start date: October 25, 2017
• Est. completion date: December 22, 2017

Study information

• Verified date: January 2018
• Source: Cryobeauty
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 22, 2017
• Est. primary completion date: December 22, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Lentigo
• Solar Lentigo

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	CPCAD	Nice

Sponsors (2)

Lead Sponsor	Collaborator
Cryobeauty	CEISO

Country where clinical trial is conducted

France, 

Outcome

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