NCT06361251

Interventional, Monocentric, Double-blind Randomized Category 2b Study Evaluating the Evaluation of the Tolerance of Cyto-selective Difluoroethane-based Cryotherapy in the Treatment of Brown Spots (Solar and Senile Lentigines, Post -Inflammatory Hyperpigmentation (Pih)) on the Face

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Cryonove Pharma · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to compare the 2 different prototype of cytoselectivecryotherapy 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 2 prototypes of cyto-selective cryotherapy treatments * the performance of 2 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.

Conditions

• Lentigo
• Solar Lentigo
• Post Inflammatory Hyperpigmentation

Interventions

Type	Name	Description
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 (EC05osc)	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). The prototype is intended to treat pigmented spots of the face (PIH spots and senile and solar lentigos).

Timeline

• Start date: 2024-09-16
• Primary completion: 2024-12-12
• Completion: 2024-12-12
• First posted: 2024-04-11
• Last updated: 2024-12-24

Locations

1 site across 1 country: South Africa