NCT04995549

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 9, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

November 26, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 19, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 22, 2022

Completed
Last Updated

March 21, 2023

Status Verified

March 1, 2023

Enrollment Period

2 months

First QC Date

May 19, 2021

Last Update Submit

March 20, 2023

Conditions

Unrecognized Condition

Keywords

skin, non lesional, arm

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Measures using Cutiscan® CS 100

EXPERIMENTAL
Device: Cutiscan® CS 100

Interventions

Cutiscan® CS 100DEVICE

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

Measures using Cutiscan® CS 100

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de besançon

Besançon, 25030, France

Location

Study Officials

  • Brice CHATELAIN, MD

    CHU DE BESANCON

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2021

First Posted

August 9, 2021

Study Start

November 26, 2021

Primary Completion

January 19, 2022

Study Completion

February 22, 2022

Last Updated

March 21, 2023

Record last verified: 2023-03

Locations

FR(1)