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NOT YET RECRUITING
NCT06305897
NA

Evaluation of the Tolerance (Main Objective) and Performance of Cyto-selective Difluoroethane-based Cryotherapy in the Treatment of Brown Spots (Solar and Senile Lentigines, Post-inflammatory Hyperpigmentation) on the Face

Sponsor: Cryonove Pharma

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to compare the 3 different prototype of cyto-selective cryotherapy devices (name of the devices : CRYONOVE) use in brown spots on the face of subject from different ethnicities. The main questions it aims to answer are: * the tolerance of 3 prototypes of cyto-selective cryotherapy treatments * the performance of 3 prototypes of cyto-selective cryotherapy treatments Participants will be treated for each spots with a definied prototype during 6 treatment visits. Researchers will compare the tolerance and performance of the 3 prototypes.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

45

Start Date

2024-04

Completion Date

2024-12

Last Updated

2024-04-17

Healthy Volunteers

Yes

Interventions

DEVICE

CRYONOVE (EC14_4osc)

The prototype is a variant version from that of a CE marked MD already commercialized (Cryobeauty mains, Cryobeauty Pharma SAS, France) which produces a cryogenic spray sequence (EC14). The prototype is intended to treat pigmented spots of the face (PIH spots and senile and solar lentigos).

DEVICE

CRYONOVE (EC+05_1osc)

The prototype is a variant version from that of a CE marked MD already commercialized (Cryobeauty mains, Cryobeauty Pharma SAS, France) which produces a cryogenic spray sequence (EC05\_1osc). The prototype is intended to treat pigmented spots of the face (PIH spots and senile and solar lentigos).

DEVICE

CRYONOVE (EC+05_2osc)

The prototype is a variant version from that of a CE marked MD already commercialized (Cryobeauty mains, Cryobeauty Pharma SAS, France) which produces a cryogenic spray sequence (EC05\_2osc). The prototype is intended to treat pigmented spots of the face (PIH spots and senile and solar lentigos).