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

Not Applicable

Completed

• Conditions: Solar Lentigo
• Interventions: Device: CRYOBEAUTY MAINS

• Registration Number: NCT03157427
• Lead Sponsor: Cryobeauty

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-03
• Study First Submitted QC: 2017-05-15
• Study First Posted: 2017-05-17
• Study Start: 2017-06-21
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-11
• Primary Completion: 2017-09-12
• Study Completion: 2017-09-12
• Last Update Posted: 2017-09-12

Recruitment & Eligibility

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

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CRYOBEAUTY MAINS	CRYOBEAUTY MAINS	Cryotherapy medical device designed to treat solar lentigo on the randomized hand.

Primary Outcome Measures

Name	Time	Method
Evaluation of CRYOBEAUTY MAINS's performance	8 weeks	Hexsel scoring: 1. \> Very significant clearance (about 90%); only minor evidence of hyper pigmentation remains; 2. \> Significant improvement (about 75%); some evidence 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
Evaluation of solar lentigines colors	8 weeks	Colors assessment: by using Mexameter® MX 18
Assessment of pain intensity	0 week : same-day following the CRYOBEAUTY MAINS treatment	VAS
Assessment of volunteers feeling (QoL)	8 weeks	MelasQoL (Melasma. Quality of Life Scale)
Evaluation of solar lentigines numbers	8 weeks	Counting by enumeration of spots
Complication and adverse events rate	8 weeks	Any complications or adverse events related or not to the treatment will be collected and evaluated.
Assessment of ergonomic and device's readiness	0 week : same-day following the CRYOBEAUTY MAINS treatment	Ergonomic and device's readiness questionnaire : 6 QCM questions are given to the participants
Evaluation of CRYOBEAUTY MAINS's performance	4 weeks	Hexsel scoring: 1. \> Very significant clearance (about 90%); only minor evidence of hyper pigmentation remains; 2. \> Significant improvement (about 75%); some evidence 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 Hôpital Archet 2; 🇫🇷 Nice, France