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

Summary

CS5\_1 study aim to evaluate the tolerance and to adjust the mode of administration of 4 different conditions of cryotherapy treatments applied on the brown spots of the face and hand with 3 prototypes.

Each treatment corresponds to a combination of a specific sequence of a cryogenic spray and of a frequency of application.

The study will evaluate 3 prototypes :

* Prototype 1 : from (815-v1 001) to (815-v1 100)
* Prototype 2 : from (815-v1 101) to (815-v1 150)
* Prototype 3 : from (815-v1 151) to (815-v1 200)

Conditions

• Lentigo Solar

Interventions

DEVICE

Prototypes (815-v1 001) to (815-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 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

Prototype (815-v1 051) to (815-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 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

Prototypes (815-v1 101) to (815-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 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

Prototypes (815-v1 151) to (815-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 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.

Sponsors & Collaborators

• Dermatech

  collaborator INDUSTRY

• CEISO

  collaborator INDUSTRY

• LTD HEALTH

  collaborator UNKNOWN

• Cryonove Pharma

  lead INDUSTRY

Principal Investigators

• Lela BERIDZE · LTD HEALTH

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

SEQUENTIAL

Eligibility

Min Age

30 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-10-21

Primary Completion

2023-06-08

Completion

2023-06-08

Countries

• Georgia

Study Locations