NCT05071456

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)

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

September 9, 2021

Completed
29 days until next milestone

First Posted

Study publicly available on registry

October 8, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

October 15, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2021

Completed
Last Updated

October 18, 2021

Status Verified

September 1, 2021

Enrollment Period

2 months

First QC Date

September 9, 2021

Last Update Submit

October 15, 2021

Conditions

Keywords

ElectrochemistrySqualeneNMFSkin

Outcome Measures

Primary Outcomes (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

    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 Outcomes (3)

  • Validation of the measure process for different skin type e.g: dry, oily, normal

    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.

    Day 0 or Day 1

  • Describe individuals' habits or daily routine for skin care using a questionnairemethodology (corneometry or chromatography)

    Day 0 or Day 1

Study Arms (3)

Atopic dermatitis patients

EXPERIMENTAL
Other: Collects of skin's hydration

Patient with oily acne skin

EXPERIMENTAL
Other: Collects of skin's hydration

Control group of patient without facial dermatosis

ACTIVE COMPARATOR
Other: Collects of skin's hydration

Interventions

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

Atopic dermatitis patientsControl group of patient without facial dermatosisPatient with oily acne skin

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≤ 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hôpitaux de Paris - CHU Henri Mondor

Créteil, 94040 Créteil Cedex, France

Location

MeSH Terms

Conditions

Dermatitis, AtopicAcne Vulgaris

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System DiseasesAcneiform EruptionsSebaceous Gland Diseases

Study Officials

  • Tu Anh Duong, MD PhD

    Assistance Publique - Hôpitaux de Paris

    STUDY DIRECTOR

Central Study Contacts

Tu Anh Duong, MD PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2021

First Posted

October 8, 2021

Study Start

October 15, 2021

Primary Completion

December 16, 2021

Study Completion

December 16, 2021

Last Updated

October 18, 2021

Record last verified: 2021-09

Locations