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Interventional, Monocentric, Double-blind Randomized Category 2b Study Evaluating the Evaluation of the Tolerance of Cyto-selective Difluoroethane-based Cryotherapy in the Treatment of Brown Spots (Solar and Senile Lentigines, Post -Inflammatory Hyperpigmentation (Pih)) on the Face

NCT06361251 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-12-24

No results posted yet for this study

Summary

The goal of this clinical trial is to compare the 2 different prototype of cytoselectivecryotherapy devices (name of the devices : CRYONOVE) use in brown spots on the face of subject from different ethnicities. The main questions it aims to answer are:

* the tolerance of 2 prototypes of cyto-selective cryotherapy treatments
* the performance of 2 prototypes of cyto-selective cryotherapy treatments Participants will be treated for each spots with a definied prototype during 6 treatment visits.

Researchers will compare the tolerance and performance of the 3 prototypes.

Conditions

  • Lentigo
  • Solar Lentigo
  • Post Inflammatory Hyperpigmentation

Interventions

DEVICE

CRYONOVE (EC14_4osc)

The prototype is a variant version from that of a CE marked MD already commercialized (Cryobeauty mains, Cryobeauty Pharma SAS, France) which produces a cryogenic spray sequence (EC14). The prototype is intended to treat pigmented spots of the face (PIH spots and senile and solar lentigos).

DEVICE

CRYONOVE (EC05osc)

The prototype is a variant version from that of a CE marked MD already commercialized (Cryobeauty mains, Cryobeauty Pharma SAS, France) which produces a cryogenic spray sequence (EC05). The prototype is intended to treat pigmented spots of the face (PIH spots and senile and solar lentigos).

Sponsors & Collaborators

  • Dermatech

    collaborator INDUSTRY

  • Cryonove Pharma

    lead INDUSTRY

Principal Investigators

  • Victoria DAUPHANT · Dermatech

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-16
Primary Completion
2024-12-12
Completion
2024-12-12

Countries

  • South Africa

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 NCT06361251 on ClinicalTrials.gov