SKin Uncertainties Modeling (SKUM)

March 20, 2023 updated by: Centre Hospitalier Universitaire de Besancon

Construction of a Mechanical Data Base for Mathematically Modeling Uncertainties in Human Skin Tissues

The study is based on measurement device and will provide a database of viscoelastic properties of the forearm skin among healthy volunteers.

These data will be used to develop a mathematical model representative of the mechanical behavior of the skin.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besançon, France, 25030
        • CHU de Besançon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy volunteers aged 18 to 50 years old
  • non-opposition to participating in SKUM study
  • Affiliation to french social security

Exclusion Criteria:

  • Refusal to participate
  • Volunteer with any skin disease likely to interfere with the primary outcome
  • Legal incapacity or limited legal capacity
  • Subject unlikely to cooperate with the study and / or weak cooperation
  • Subject without health insurance
  • Pregnant woman
  • Subject being in the period of exclusion from another study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Measures using Cutiscan® CS 100
Device: Cutiscan® CS 100
Repeated measures on healthy volunteers skin (forearm) are performed using Cutiscan® CS 100 device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Height of displacement (mm) of a skin disc.
Time Frame: Month 1
The displacement will be obtained from repeated measures, on 30 volunteers, on forearm skin, and using Cutiscan® CS100 device. A database of skin viscoelasticity measure will be built from such data.
Month 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Investigators

  • Principal Investigator: Brice CHATELAIN, MD, CHU de Besançon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 26, 2021

Primary Completion (Actual)

January 19, 2022

Study Completion (Actual)

February 22, 2022

Study Registration Dates

First Submitted

May 19, 2021

First Submitted That Met QC Criteria

July 29, 2021

First Posted (Actual)

August 9, 2021

Study Record Updates

Last Update Posted (Actual)

March 21, 2023

Last Update Submitted That Met QC Criteria

March 20, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2020/527

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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