MedTrace Logo

Cyto-selective Difluoroethane-based Cryotherapy in the Treatment of Brown Spots PROOF OF CONCEPT

NCT05014321 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2022-06-30

No results posted yet for this study

Summary

CRYO (N° 21D588A0001) study aims to evaluate the tolerance and adjust the mode of administration of a cyto-selective difluoroethane-based cryotherapy in the treatment of brown spots.

The study is a proof of concept on a small panel of subjects and has been designed to be interventional, monocentric, randomized and double blind.

The study will include three device prototypes and a CE marked device (trademark URGO CRYOBEAUTY MAINS-BRAS-JAMBES) used as reference.

Conditions

  • Lentigo Solar

Interventions

DEVICE

EC16 medical device (CE marked)

Application on brown spots located on the face (1 treatment during the study).

DEVICE

device prototype (810A-v1)

Application on brown spots located on the face (4 treatments during the study).

DEVICE

device prototype (810B-v1)

Application on brown spots located on the face (4 treatments during the study).

DEVICE

device prototype (810C-v1)

Application on brown spots located on the face (4 treatments during the study).

Sponsors & Collaborators

  • Dermatech

    collaborator INDUSTRY

  • INNOVSOLUTION

    collaborator UNKNOWN

  • CEISO

    collaborator INDUSTRY

  • Cryonove Pharma

    lead INDUSTRY

Principal Investigators

  • Natalia Didenko, MD · VIDNOVLENNYA invetigation site

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
30 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-14
Primary Completion
2021-05-20
Completion
2021-07-16

Countries

  • Ukraine

Study Locations

More Related Trials

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 NCT05014321 on ClinicalTrials.gov