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Electrochemistry Measurement of Skin Hydration Parameters (SKINBIOSENSE)

Primary Purpose

Atopic Dermatitis, Acne, Skin Electrochemistry

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Collects of skin's hydration
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Atopic Dermatitis focused on measuring Electrochemistry, Squalene, NMF, Skin

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 18 ≤ Age ≤ 70
  • Subjects with past history or follow-up for acne or rosacea stage I ou II, atopic dermatitis mild to moderate without immunosuppressive treatment
  • Subjects enabling to perform a one day visit at the hospital
  • Written consent according to local regulatory requirements
  • Affiliated to a social security scheme

Exclusion Criteria:

  • Pregnant women or breastfeeding
  • Patient under guardianship or curatorship, legal protection or protection of justice
  • Participation in other interventional research on skin moisturizer

Sites / Locations

  • Assistance Publique Hôpitaux de Paris - CHU Henri Mondor

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Atopic dermatitis patients

Patient with oily acne skin

Control group of patient without facial dermatosis

Arm Description

Outcomes

Primary Outcome Measures

Feasibility of collecting an electrochemical measure of skin hydration parameter (natural moisturizer factor electric signal) at two different sites of the face at T0 using patch and electrode
Feasibility of collecting an electrochemical measure of skin hydration parameter (natural moisturizer factor electric signal) at two different sites of the face at T0 using patch and electrode. Signal detection (mVolt) or not using a patch to collect skin surface parameter applied on an electrode to collect and electric signal.

Secondary Outcome Measures

Validation of the measure process for different skin type e.g: dry, oily, normal
Rate of failure by site or skin type, obtained measure mean and SD for all and regarding each group
Determine the correlation between electrochemistry measures or skin hydration (level of electrical signal mvolt ) and reference method: corneometry or chromatography.
Those two methods are routinely used to asses skin hydration using a swab contact then migration in a chromatography column or use of sebumeter Correlation coefficient between level of electrochemical measure (signal) regarding skin types and measures issued from reference methodology (corneometry or chromatography)
Describe individuals' habits or daily routine for skin care using a questionnairemethodology (corneometry or chromatography)
Descriptive statistics: smoke, sun exposure, moisturizer use

Full Information

First Posted
September 9, 2021
Last Updated
October 15, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
SYNELVIA, WIRED BEAUTY Technologies
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1. Study Identification

Unique Protocol Identification Number
NCT05071456
Brief Title
Electrochemistry Measurement of Skin Hydration Parameters
Acronym
SKINBIOSENSE
Official Title
Pilot Study Assessing the Feasibility and Reliability of Measurements of Skin's Parameters Hydration by Electrochemistry
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 15, 2021 (Anticipated)
Primary Completion Date
December 16, 2021 (Anticipated)
Study Completion Date
December 16, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
SYNELVIA, WIRED BEAUTY Technologies

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To date measuring the effect of dermocosmetic products on the main identified factors of aging and alteration of the skin barrier is based on invasive and expensive experiments. Electrochemistry enables to measure a specific signal for a substance of interest e.g. Vitamin C using an surface contact with an electrode. Therefore, this study will evaluate the reliability and feasibility of measurements of skin's hydration parameters such as NMF and squalene using electrochemistry. These study will be made on three groups of individuals with different skin types: dry skin i.e. atopic dermatitis patients, oily skin i.e. acne skin and a control group of individual without facial dermatosis. Collects of parameters of interest will be made by using patch using electrochemistry (contact with an electrode and potentiostat to detect an electric signal) . It is a simple method that relies on a sensor / electrode pair that allows a study of the surface molecules of the skin. Application in the measurement of vitamin C in food products has already been validated. On a second hand, a collect by chromatography of the parameters of interest will be carried out in order to compare the new method with the reference method. This procedure has been developed via a procedure including collecting surface parameters using a patch an developping special electrodes and miniaturized detecting signal tool (potentiostat)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis, Acne, Skin Electrochemistry
Keywords
Electrochemistry, Squalene, NMF, Skin

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study will include sixty subjects separate into three groups of twenty subjects based on the skin disease: acne, atopic dermatitis and a group control. This is a study validating the feasibility of a measure collected by a tool at the prototype stage with a view to pre-industrialization. The following process is: Measurement by patches and sensors of substances of interest on 2 areas of the face separated by the midline (forehead / cheek). Collection on the skin surface by 2 swabs repeated on 2 areas
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Atopic dermatitis patients
Arm Type
Experimental
Arm Title
Patient with oily acne skin
Arm Type
Experimental
Arm Title
Control group of patient without facial dermatosis
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Collects of skin's hydration
Intervention Description
Collects of skin's hydration will be made by using patch using electrochemistry.
Primary Outcome Measure Information:
Title
Feasibility of collecting an electrochemical measure of skin hydration parameter (natural moisturizer factor electric signal) at two different sites of the face at T0 using patch and electrode
Description
Feasibility of collecting an electrochemical measure of skin hydration parameter (natural moisturizer factor electric signal) at two different sites of the face at T0 using patch and electrode. Signal detection (mVolt) or not using a patch to collect skin surface parameter applied on an electrode to collect and electric signal.
Time Frame
Day 0 or Day 1
Secondary Outcome Measure Information:
Title
Validation of the measure process for different skin type e.g: dry, oily, normal
Description
Rate of failure by site or skin type, obtained measure mean and SD for all and regarding each group
Time Frame
Day 0 or Day 1
Title
Determine the correlation between electrochemistry measures or skin hydration (level of electrical signal mvolt ) and reference method: corneometry or chromatography.
Description
Those two methods are routinely used to asses skin hydration using a swab contact then migration in a chromatography column or use of sebumeter Correlation coefficient between level of electrochemical measure (signal) regarding skin types and measures issued from reference methodology (corneometry or chromatography)
Time Frame
Day 0 or Day 1
Title
Describe individuals' habits or daily routine for skin care using a questionnairemethodology (corneometry or chromatography)
Description
Descriptive statistics: smoke, sun exposure, moisturizer use
Time Frame
Day 0 or Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18 ≤ Age ≤ 70 Subjects with past history or follow-up for acne or rosacea stage I ou II, atopic dermatitis mild to moderate without immunosuppressive treatment Subjects enabling to perform a one day visit at the hospital Written consent according to local regulatory requirements Affiliated to a social security scheme Exclusion Criteria: Pregnant women or breastfeeding Patient under guardianship or curatorship, legal protection or protection of justice Participation in other interventional research on skin moisturizer
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tu Anh Duong, MD PhD
Phone
01 49 09 44 29
Ext
+ 33
Email
tu-anh.duong@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
David Schmitz
Phone
01 49 81 36 32
Ext
+ 33
Email
david.schmitz@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tu Anh Duong, MD PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Study Director
Facility Information:
Facility Name
Assistance Publique Hôpitaux de Paris - CHU Henri Mondor
City
Créteil
ZIP/Postal Code
94040 Créteil Cedex
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tu Anh Duong, MD PhD
Phone
01 49 09 44 29
Ext
+ 33
Email
tu-anh.duong@aphp.fr

12. IPD Sharing Statement

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Electrochemistry Measurement of Skin Hydration Parameters

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