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

Summary

CS5\_3 aims 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 hands with 3 prototypes. A brown spot is defined as solar or senile lentigo and post-inflammatory hyperpigmentation (PIH).

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 : SN from (816-v1 001) to (816-v1 100)
* Prototype 2 : SN from (816-v1 101) to (816-v1 150)
* Prototype 3 : SN from (816-v1 151) to (816-v1 200)

Prototypes will be applied on the face and hands according to specific frequencies of application.

Conditions

• Solar Lentigo
• Senile Lentigo
• Post-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.

Sponsors & Collaborators

• CEISO

  collaborator INDUSTRY

• Dermatech

  collaborator INDUSTRY

• Sefako Makgatho Health Sciences University

  collaborator OTHER

• Cryonove Pharma

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-04-17

Primary Completion

2023-08-07

Completion

2023-10-10

Countries

• South Africa

Study Locations