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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03157427
Other study ID # 2017-A00068-45
Secondary ID
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
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Completed NCT05625815 - Tolerance and Performance of Cyto-selective Difluoroethane-based Cryotherapy in the Treatment of Brown Spots. N/A