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

NCT03157427 | Completed

• 1 other identifier: 2017-A00068-45
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Solar Lentigo

Keywords

Solar Lentigo, Cryotherapy, Difluoroethane

Outcome Measures

Primary Outcomes (1)

• 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 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)

  8 weeks

Secondary Outcomes (16)

• Evaluation of solar lentigines numbers

  0 week : same-day following the CRYOBEAUTY MAINS treatment

• Evaluation of solar lentigines numbers

  4 weeks

• Evaluation of solar lentigines numbers

  8 weeks

• Evaluation of solar lentigines colors

  0 week : same-day following the CRYOBEAUTY MAINS treatment

• Evaluation of solar lentigines colors

  4 weeks

Study Arms (2)

CRYOBEAUTY MAINS

EXPERIMENTAL

Cryotherapy medical device designed to treat solar lentigo on the randomized hand.

Device: CRYOBEAUTY MAINS

Control

NO INTERVENTION

The non randomized hand is not teated.

Interventions

CRYOBEAUTY MAINS DEVICE

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)

CRYOBEAUTY MAINS

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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 ...).

Sponsors & Collaborators

• Cryobeauty: lead
• CEISO: collaborator

Study Sites (1)

Cpcad Nice Hôpital Archet 2

Nice, 06200, France

Location

Study Officials

• Catherine Queille-Roussel, MD

  CPCAD Nice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients will be treated on the randomized hand, the other hand is the comparator/control. Comparison between the treated hand and the control hand will be performed.

Study Record Dates

• First Submitted: May 3, 2017
• First Posted: May 17, 2017
• Study Start: June 21, 2017
• Primary Completion: September 12, 2017
• Study Completion: September 12, 2017
• Last Updated: September 12, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)