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NCT04995549 Clinical Trial

SKin Uncertainties Modeling

Unrecognized Condition Clinical Trial

— SKUM  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04995549
Other study ID # 2020/527
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 26, 2021
Est. completion date February 22, 2022

Study information
Verified date March 2023
Source Centre Hospitalier Universitaire de Besancon
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 32
Est. completion date February 22, 2022
Est. primary completion date January 19, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• Cutiscan® CS 100
Repeated measures on healthy volunteers skin (forearm) are performed using Cutiscan® CS 100 device

Locations
Country Name City State
France CHU de besançon Besançon

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Height of displacement (mm) of a skin disc. 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
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