Electrochemistry Measurement of Skin Hydration Parameters (SKINBIOSENSE)

October 15, 2021 updated by: Assistance Publique - Hôpitaux de Paris

Pilot Study Assessing the Feasibility and Reliability of Measurements of Skin's Parameters Hydration by Electrochemistry

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)

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

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 Contact

Study Contact Backup

Study Locations

  • France
      • Créteil, France, 94040 Créteil Cedex
        • Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR
        • Contact:

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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Atopic dermatitis patients
Other: Collects of skin's hydration
Collects of skin's hydration will be made by using patch using electrochemistry.
Experimental: Patient with oily acne skin
Other: Collects of skin's hydration
Collects of skin's hydration will be made by using patch using electrochemistry.
Active Comparator: Control group of patient without facial dermatosis
Other: Collects of skin's hydration
Collects of skin's hydration will be made by using patch using electrochemistry.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: Day 0 or Day 1
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.
Day 0 or Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validation of the measure process for different skin type e.g: dry, oily, normal
Time Frame: Day 0 or Day 1
Rate of failure by site or skin type, obtained measure mean and SD for all and regarding each group
Day 0 or Day 1
Determine the correlation between electrochemistry measures or skin hydration (level of electrical signal mvolt ) and reference method: corneometry or chromatography.
Time Frame: Day 0 or Day 1
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)
Day 0 or Day 1
Describe individuals' habits or daily routine for skin care using a questionnairemethodology (corneometry or chromatography)
Time Frame: Day 0 or Day 1
Descriptive statistics: smoke, sun exposure, moisturizer use
Day 0 or Day 1

Collaborators and Investigators

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

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

SYNELVIA
WIRED BEAUTY Technologies

Investigators

  • Study Director: Tu Anh Duong, MD PhD, Assistance Publique - Hôpitaux de Paris

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 (Anticipated)

October 15, 2021

Primary Completion (Anticipated)

December 16, 2021

Study Completion (Anticipated)

December 16, 2021

Study Registration Dates

First Submitted

September 9, 2021

First Submitted That Met QC Criteria

September 27, 2021

First Posted (Actual)

October 8, 2021

Study Record Updates

Last Update Posted (Actual)

October 18, 2021

Last Update Submitted That Met QC Criteria

October 15, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP210446

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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