Tolerance and Performance of Cyto-selective Difluoroethane-based Cryotherapy in the Treatment of Brown Spots (Solar and Senile Lentigines, Post-Inflammatory Hyperpigmentation)

NAUnknownINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

June 10, 2023

Primary Completion Date

December 12, 2023

Study Completion Date

December 12, 2023

Conditions
Solar LentigoSenile LentigoPost Inflammatory Hyperpigmentation
Interventions
DEVICE

Condition 1 : Prototypes (816-v1) every weeks

Application on brown spots located on the face and/or the hand (12 treatments during the study). An operator previously trained by the dermatologist will apply the study device to the patient's face or/and hand. Subjects will be lying down, and the prototypes will be administered upside down for the applications on the face and sitting for the applications on the hands. For the application on the hands, the hands will be placed flat on the table and the prototypes will be applied upside down. During applications on the face, subjects will wear diving goggles protecting the eyes from cryogenic gas.

DEVICE

Condition 2 : Prototypes (816-v1) every two weeks

Application on brown spots located on the face and/or the hand (6 treatments during the study). An operator previously trained by the dermatologist will apply the study device to the patient's face or/and hand. Subjects will be lying down, and the prototypes will be administered upside down for the applications on the face and sitting for the applications on the hands. For the application on the hands, the hands will be placed flat on the table and the prototypes will be applied upside down. During applications on the face, subjects will wear diving goggles protecting the eyes from cryogenic gas.

Trial Locations (1)

0204

Photobiology Laboratory, Sefako Makgatho Health Sciences University, Pretoria

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Dermatech

INDUSTRY

collaborator

CEISO

INDUSTRY

collaborator

Sefako Makgatho Health Sciences University

OTHER

lead

Cryonove Pharma

INDUSTRY

NCT05883657 - Tolerance and Performance of Cyto-selective Difluoroethane-based Cryotherapy in the Treatment of Brown Spots (Solar and Senile Lentigines, Post-Inflammatory Hyperpigmentation) | Biotech Hunter | Biotech Hunter