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Tolerance of Cyto-selective Difluoroethane-based Cryotherapy

NCT05322668 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2022-08-19

No results posted yet for this study

Summary

Cryotherapy is more and more used to improve skin appearance. Devices using difluoroethane, manufactured by CRYONOVE PHARMA, are already available on the local and international markets, e.g. CRYOBEAUTY MAINS and CRYOBEAUTY CORPS.

However, the cryogenic gas (conventional cryotherapy - liquid nitrogen) creates a dermabrasion of the skin surface and person receiving this kind of treatment presents an impaired skin during a few days following the treatment as temporary damage of stratum corneum, erythema, scars, burns.

Following the side effects occurring after conventional cryotherapy application, it seems interesting for the sponsor to select other sequences of a cryogenic spray (4 prototypes of devices) which could be used for lentigo treatment with a same benefit for the consumers without any safety outcomes.

This study will assess the use of different prototypes with a sequence of application of cryogenic gas which reaches a higher temperature than those which used with the reference device, in order to increase the acceptability of the device.

(CS4\_3) proof of concept, interventional, monocentric, aims to evaluate the tolerance of cryotherapy treatments applied on healthy skin on the back of the hands.

The main objective of the study is to evaluate on phototype V and VI, the tolerance of 4 different conditions of cryotherapy treatments (4 prototypes) applied on healthy skin on the back of the hands.

Conditions

  • Solar Lentigo

Interventions

DEVICE

Prototypes (812A-v1), (812C-v1), (812D-v1) and (812F-v1)

All the subjects will receive all the treatment in the same order. On each hand 2 devices will be attributed as follow: * Prototypes (812A-v1) will be applied on an area of the back of the patient's right hand, on healthy skin * Prototypes (812C-v1) will be applied on an area of the back of the patient's right hand, on healthy skin * Prototypes (812D-v1) will be applied on an area of the back of the patient's left hand, on healthy skin * Prototypes (812F-v1) will be applied on an area of the back of the patient's left hand, on healthy skin

Sponsors & Collaborators

  • INNOVSOLUTION

    collaborator UNKNOWN

  • CEISO

    collaborator INDUSTRY

  • Dermatech

    collaborator INDUSTRY

  • Cryonove Pharma

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-17
Primary Completion
2022-02-07
Completion
2022-02-07

Countries

  • Ukraine

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 NCT05322668 on ClinicalTrials.gov