Atopic DermatitisNCT03813472
Hydration Sensor for Atopic Dermatitis
An observational study of Atopic Dermatitis and Healthy Children, run by Northwestern University at 1 site in United States.
Trial summary
Pilot study of a soft, flexible hydration sensor Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Atopic Dermatitis, Healthy Children
- What is being tested?
- Hydration Sensor
- Type of treatment
- Medical device
- How many people
- 172 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Nov 2019to 28 Feb 2023
- Phase
- Observational
- 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 Up to 18 years
- All sexes
- Child, Adult
Study population: Healthy, aged matched controls or children with prior diagnosis of atopic dermatitis as confirmed by clinical diagnosis by a board-certified dermatologist
Who may be able to join
- Children <18 years of age
- Children with new or prior atopic dermatitis diagnosis
- English speaking
- Children who are healthy, aged matched controls
Who cannot join
- Individuals who are pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of Skin Hydration Sensor for Atopic Dermatitis
Pilot study of a soft, flexible hydration sensor
Read the detailed description
Assessment of accuracy and feasibility of a skin hydration sensor at detecting differences in skin hydration between skin affected by atopic dermatitis and areas not affected.
- Conditions
- Atopic Dermatitis, Healthy Children
- Being tested
- Hydration Sensor
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydration SensorDevice
This device includes a hydration sensor embedded within silicone and applied to the skin with a medical grade adhesive.
| Study group | Role | What they receive |
|---|---|---|
| Atopic Dermatitis | Evaluate sensor performance for hydration sensing. Receives: Device: Hydration Sensor | |
| Healthy aged matched controls | Evaluate sensor performance for hydration sensing. Receives: Device: Hydration Sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Agreement
Percent agreement between experimental sensor and commercially available transepidermal water loss meter.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study start25 Nov 2019
- Primary completion12 May 2021
- Study completion28 Feb 2023
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 Northwestern UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shuai (Steve) Xu, Northwestern University
- Investigators
- Shuai Xu, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03813472
- Sponsor's protocol ID
- SX08152018
- Status last verified
- May 2023
- First submitted
- 20 Jan 2019
- Last updated
- 6 May 2023
- 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 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Skin Hydration Sensor for Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT03813472
- Acronym / sponsor ID
- SX08152018
- Conditions
- Atopic Dermatitis, Healthy Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 25 Nov 2019 (actual)
- Primary completion
- 12 May 2021 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 23 Jan 2019 (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.
Pilot study of a soft, flexible hydration sensor
Detailed description
Assessment of accuracy and feasibility of a skin hydration sensor at detecting differences in skin hydration between skin affected by atopic dermatitis and areas not affected.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atopic Dermatitis | – | Device: Hydration SensorEvaluate sensor performance for hydration sensing. |
| Healthy aged matched controls | – | Device: Hydration SensorEvaluate sensor performance for hydration sensing. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Healthy, aged matched controls or children with prior diagnosis of atopic dermatitis as confirmed by clinical diagnosis by a board-certified dermatologist
Key inclusion criteria (4 listed)
- Children <18 years of age
- Children with new or prior atopic dermatitis diagnosis
- English speaking
- Children who are healthy, aged matched controls
Key exclusion criteria (1 listed)
- Individuals who are pregnant
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 |
|---|---|---|
| Hydration SensorThis device includes a hydration sensor embedded within silicone and applied to the skin with a medical grade adhesive. | Device | Atopic Dermatitis, Healthy aged matched controls |
Primary outcome
Percent Agreement
Time frame: 1 hour
Percent agreement between experimental sensor and commercially available transepidermal water loss meter.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
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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.
Shuai Xu principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis and Healthy Children, run by Northwestern University at 1 site in United States.
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 4 inclusion and 1 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: finished, as of the sponsor's last update on 6 May 2023. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Agreement (time frame: 1 hour). 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 6 May 2023.