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临床试验/NCT05071456
NCT05071456Unknown不适用

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

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年10月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
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

研究概览

简要总结

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)

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

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

研究组 & 干预措施

Atopic dermatitis patients

Experimental

干预措施: Collects of skin's hydration (Other)

Patient with oily acne skin

Experimental

干预措施: Collects of skin's hydration (Other)

Control group of patient without facial dermatosis

Active Comparator

干预措施: Collects of skin's hydration (Other)

结局指标

主要结局

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

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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