Clinical trial NCT05071456: Electrochemistry Measurement of Skin Hydration Parameters
Official title: Pilot Study Assessing the Feasibility and Reliability of Measurements of Skin's Parameters Hydration by Electrochemistry
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atopic Dermatitis
Acne
Skin Electrochemistry
Keywords: Electrochemistry
Squalene
NMF
Skin
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: SYNELVIA
name: WIRED BEAUTY Technologies
First posted: 2021-10-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: OTHER

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)


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

Primary outcomes:
measure: 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
timeFrame: Day 0 or Day 1
Secondary outcomes:
measure: Validation of the measure process for different skin type e.g: dry, oily, normal
timeFrame: Day 0 or Day 1
measure: Determine the correlation between electrochemistry measures or skin hydration (level of electrical signal mvolt ) and reference method: corneometry or chromatography.
timeFrame: Day 0 or Day 1
measure: Describe individuals' habits or daily routine for skin care using a questionnairemethodology (corneometry or chromatography)
timeFrame: Day 0 or Day 1
Other outcomes:
Locations:
city: Créteil
country: France
facility: Assistance Publique Hôpitaux de Paris - CHU Henri Mondor
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Tu Anh Duong, MD PhD
role: STUDY_DIRECTOR
References: