Tolerance and Performance of Cyto-selective Difluoroethane-based Cryotherapy in the Treatment of Brown Spots.

NACompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

April 17, 2023

Primary Completion Date

August 7, 2023

Study Completion Date

October 10, 2023

Conditions
Solar LentigoSenile LentigoPost-inflammatory Hyperpigmentation
Interventions
DEVICE

Prototypes (816-v1 001) to (816-v1 050)

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 supine, 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

Prototype (816-v1 051) to (816-v1 100)

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 supine, 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

Prototypes (816-v1 101) to (816-v1 150)

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 supine, 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

Prototypes (816-v1 151) to (816-v1 200)

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 supine, 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)

Unknown

SMU - Photobiology Laboratory, Sefako Makgatho Health Sciences University, Pretoria

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

CEISO

INDUSTRY

collaborator

Dermatech

INDUSTRY

collaborator

Sefako Makgatho Health Sciences University

OTHER

lead

Cryonove Pharma

INDUSTRY

NCT05625815 - Tolerance and Performance of Cyto-selective Difluoroethane-based Cryotherapy in the Treatment of Brown Spots. | Biotech Hunter | Biotech Hunter