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

Solar Lentigo Clinical Trial

— CBT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03157427
• Other study ID #: 2017-A00068-45
• Status: Completed
• Phase: N/A
• First received: May 3, 2017
• Last updated: September 11, 2017
• Start date: June 21, 2017
• Est. completion date: September 12, 2017

Study information

• Verified date: September 2017
• Source: Cryobeauty
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 12, 2017
• Est. primary completion date: September 12, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lentigo
• Solar Lentigo

Intervention

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)

Locations

Country	Name	City	State
France	Cpcad Nice Hôpital Archet 2	Nice

Sponsors (2)

Lead Sponsor	Collaborator
Cryobeauty	CEISO

Country where clinical trial is conducted

France, 

Outcome

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