Atopic DermatitisSKINBIOSENSENCT05071456
Electrochemistry Measurement of Skin Hydration Parameters
A study testing Collects of skin's hydration in people with Atopic Dermatitis and Acne, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis, Acne, Skin Electrochemistry
- What is being tested?
- Collects of skin's hydration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 15 Oct 2021to 16 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnant women or breastfeeding
- Patient under guardianship or curatorship, legal protection or protection of justice
- Participation in other interventional research on skin moisturizer
Trial locations and contacts
1 site in 1 country.
France1 site
Assistance Publique Hôpitaux de Paris - CHU Henri Mondor
Créteil, 94040 Créteil Cedex
Tu Anh Duong, MD PhD, 01 49 09 44 29 ext. + 33, tu-anh.duong@aphp.fr
About this study
Official title: 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.
Read more
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)
- Conditions
- Atopic Dermatitis, Acne, Skin Electrochemistry
- Being tested
- Collects of skin's hydration
- Keywords
- Electrochemistry, Squalene, NMF, Skin
- Medical subject headings
- Dermatitis, Atopic, Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collects of skin's hydrationOther
Collects of skin's hydration will be made by using patch using electrochemistry.
| Study group | Role | What they receive |
|---|---|---|
| Atopic dermatitis patients | Experimental | Not described Receives: Other: Collects of skin's hydration |
| Patient with oily acne skin | Experimental | Not described Receives: Other: Collects of skin's hydration |
| Control group of patient without facial dermatosis | Active comparator | Not described Receives: Other: Collects of skin's hydration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0 or Day 1
Secondary outcomes (3)
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
Measured: 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.
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)
Measured: Day 0 or Day 1
Describe individuals' habits or daily routine for skin care using a questionnairemethodology (corneometry or chromatography)
Descriptive statistics: smoke, sun exposure, moisturizer use
Measured: Day 0 or Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2021
- Study start15 Oct 2021 (estimated)
- Primary completion16 Dec 2021 (estimated)
- Study completion16 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- SYNELVIA, WIRED BEAUTY Technologies
- Responsible party
- Sponsor
- Investigators
- Tu Anh Duong, MD PhD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05071456
- Sponsor's protocol ID
- APHP210446
- Acronym
- SKINBIOSENSE
- Status last verified
- Sep 2021
- First submitted
- 9 Sep 2021
- Last updated
- 18 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Assessing the Feasibility and Reliability of Measurements of Skin's Parameters Hydration by Electrochemistry
- ClinicalTrials.gov ID
- NCT05071456
- Acronym / sponsor ID
- SKINBIOSENSE / APHP210446
- Conditions
- Atopic Dermatitis, Acne, Skin Electrochemistry
- Keywords
- Electrochemistry, Squalene, NMF, Skin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- SYNELVIA, WIRED BEAUTY Technologies
- Study start
- 15 Oct 2021 (estimated)
- Primary completion
- 16 Dec 2021 (estimated)
- Study completion
- 16 Dec 2021 (estimated)
- First posted
- 8 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Pregnant women or breastfeeding
- Patient under guardianship or curatorship, legal protection or protection of justice
- Participation in other interventional research on skin moisturizer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collects of skin's hydrationCollects of skin's hydration will be made by using patch using electrochemistry. | Other | Atopic dermatitis patients, Control group of patient without facial dermatosis, Patient with oily acne skin |
Primary outcome
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.
3 secondary outcomes
Validation of the measure process for different skin type e.g: dry, oily, normal
Time frame: 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
Describe individuals' habits or daily routine for skin care using a questionnairemethodology (corneometry or chromatography)
Time frame: Day 0 or Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tu Anh Duong, MD PhD study director
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collects of skin's hydration in people with Atopic Dermatitis and Acne, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tu Anh Duong, MD PhD (01 49 09 44 29 ext. + 33, tu-anh.duong@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Day 0 or Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2021.