Electrochemistry Measurement of Skin Hydration Parameters

Atopic Dermatitis Clinical Trial

— SKINBIOSENSE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05071456
• Other study ID #: APHP210446
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 15, 2021
• Est. completion date: December 16, 2021

Study information

• Verified date: September 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Tu Anh Duong, MD PhD
• Phone: 01 49 09 44 29
• Email: tu-anh.duong[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 16, 2021
• Est. primary completion date: December 16, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Acne
• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic

Intervention

Other:
• Collects of skin's hydration
Collects of skin's hydration will be made by using patch using electrochemistry.

Locations

Country	Name	City	State
France	Assistance Publique Hôpitaux de Paris - CHU Henri Mondor	Créteil

Sponsors (3)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	SYNELVIA, WIRED BEAUTY Technologies

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 0 or Day 1
Secondary	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	Day 0 or Day 1
Secondary	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)	Day 0 or Day 1
Secondary	Describe individuals' habits or daily routine for skin care using a questionnairemethodology (corneometry or chromatography)	Descriptive statistics: smoke, sun exposure, moisturizer use	Day 0 or Day 1