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Tolerance and Performance (Mode of Administration) of Cyto-selective Difluoroethane-based Cryotherapy in the Treatment of Brown Spots

NCT05793619 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-11-03

No results posted yet for this study

Summary

CS5\_8 study aim to evaluate the tolerance and to adjust the mode of administration of 2 different conditions of cryotherapy treatments applied on the brown spots of the face with 1 prototype (816-v1). Each treatment corresponds to a specific frequency of cryogenic spray application.

The study will evaluate the following prototype :

• Prototypes from (816-v1 301) to (816-v1 355)

Conditions

  • Lentigo Solar
  • Senile Lentigo

Interventions

DEVICE

Prototypes (816-v1 301) to (816-v1 355) every week

Application on brown spots located on the face (6 treatments during the study). An operator previously trained by the dermatologist will apply the study device to the patient's face. Subjects will be lying down, and the prototypes will be administered upside down. During applications, subjects will wear diving goggles protecting the eyes from cryogenic gas.

DEVICE

Prototypes (816-v1 301) to (816-v1 355) every two weeks

Application on brown spots located on the face (6 treatments during the study). An operator previously trained by the dermatologist will apply the study device to the patient's face. Subjects will be lying down, and the prototypes will be administered upside down. During applications, 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
2023-04-04
Primary Completion
2023-10-26
Completion
2023-10-26

Countries

  • Georgia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05793619 on ClinicalTrials.gov