Healthy AdultsNCT03874039
Sweat and Gas Sensor for Healthy Skin and Atopic Dermatitis
An observational study of Healthy Adults and Atopic Dermatitis, run by Northwestern University at 1 site in United States.
Trial summary
Pilot study of a wearable gas and sweat skin sensor Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults, Atopic Dermatitis, Wearables
- What is being tested?
- Gas sensor and Sweat Sensor
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2019to 10 Aug 2021
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy adults and adults with prior diagnosis of atopic dermatitis from made by board certified dermatologist
Who may be able to join
- Age ≥18 years old
- Subjects willing and able to comply with requirements of the protocol
- Healthy adults or subjects with atopic dermatitis
Who cannot join
- Age <18 years old
- Subjects unwilling and able to comply with requirements of the protocol
- History of skin allergy to medical adhesive tape
- History of heat stroke, heat related or exercise related
- Non-English speaking subjects
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University
Chicago, Illinois, 60610-5402
About this study
Official title: Exploratory Study of Sweat Cytokines and Insensible Gas Losses From Skin in Healthy Normal Adults and Patients With Atopic Dermatitis
Pilot study of a wearable gas and sweat skin sensor
Read the detailed description
The objective of this study is exploratory and deploys two wearable sweat and gas sensors which detect the composition of sweat proteins and volatile gases emitted from the skin in healthy subjects and patients with atopic dermatitis.
- Conditions
- Healthy Adults, Atopic Dermatitis, Wearables, Sweat Sensor, Gas Sensor
- Being tested
- Gas sensor, Sweat 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.
Gas sensorDevice
The gas sensor is an airtight gas capsule attached with a floating solid phase microextraction (SPME) tube. SPME uses a fiber coated with a nontoxic liquid (polymer), and a nontoxic solid (sorbent). The fiber coating extracts the compounds from the gas being released from the skin. Only the glass sample is in contact with the skin.
Sweat SensorDevice
The sweat sensor is a soft, flexible device that rests on the skin and collects secreted sweat through capillary action. The device is held in place by medical-grade acrylic adhesive film.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Adults | Healthy adults with no prior diagnosis of atopic dermatitis Receives: Device: Gas sensor; Device: Sweat Sensor | |
| Atopic Dermatitis | Adults with prior diagnosis of Atopic Dermatitis from board certified dermatologist Receives: Device: Gas sensor; Device: Sweat Sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of gas exudates
Evaluation of protein contents from gas exudates from the skin
Measured: 20 minutes
Evaluation of sweat proteins
Evaluation of protein contents from sweat from the skin
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2019
- Study start15 Jan 2019
- Primary completion10 Aug 2021
- Study completion10 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultsStudies 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
- 20 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, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03874039
- Sponsor's protocol ID
- SX09092018
- Status last verified
- Apr 2022
- First submitted
- 29 Jan 2019
- Last updated
- 20 Apr 2022
- 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 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study of Sweat Cytokines and Insensible Gas Losses From Skin in Healthy Normal Adults and Patients With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT03874039
- Acronym / sponsor ID
- SX09092018
- Conditions
- Healthy Adults, Atopic Dermatitis, Wearables, Sweat Sensor, Gas Sensor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 10 Aug 2021 (actual)
- Study completion
- 10 Aug 2021 (actual)
- First posted
- 14 Mar 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 wearable gas and sweat skin sensor
Detailed description
The objective of this study is exploratory and deploys two wearable sweat and gas sensors which detect the composition of sweat proteins and volatile gases emitted from the skin in healthy subjects and patients with atopic dermatitis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Adults | – | Device: Gas sensor, Device: Sweat SensorHealthy adults with no prior diagnosis of atopic dermatitis |
| Atopic Dermatitis | – | Device: Gas sensor, Device: Sweat SensorAdults with prior diagnosis of Atopic Dermatitis from board certified dermatologist |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy adults and adults with prior diagnosis of atopic dermatitis from made by board certified dermatologist
Key inclusion criteria (3 listed)
- Age ≥18 years old
- Subjects willing and able to comply with requirements of the protocol
- Healthy adults or subjects with atopic dermatitis
Key exclusion criteria (5 listed)
- Age <18 years old
- Subjects unwilling and able to comply with requirements of the protocol
- History of skin allergy to medical adhesive tape
- History of heat stroke, heat related or exercise related
- Non-English speaking subjects
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 |
|---|---|---|
| Gas sensorThe gas sensor is an airtight gas capsule attached with a floating solid phase microextraction (SPME) tube. SPME uses a fiber coated with a nontoxic liquid (polymer), and a nontoxic solid (sorbent). The fiber coating extracts the compounds from the gas being released from the skin. Only the glass sample is in contact with the skin. | Device | Atopic Dermatitis, Healthy Adults |
| Sweat SensorThe sweat sensor is a soft, flexible device that rests on the skin and collects secreted sweat through capillary action. The device is held in place by medical-grade acrylic adhesive film. | Device | Atopic Dermatitis, Healthy Adults |
Primary outcome
Evaluation of gas exudates
Time frame: 20 minutes
Evaluation of protein contents from gas exudates from the skin
Evaluation of sweat proteins
Time frame: 20 minutes
Evaluation of protein contents from sweat from the skin
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 20 Apr 2022.
Related trials for Healthy Adults
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1/2
Clinical Trial to Assess the Safety, Tolerability, Reactogenicity, and Immunogenicity of a 10 Valent Human Papillomavirus Virus (10vHPV) Vaccine
Human Papillomavirus Infection
Not yet recruiting
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift
Healthy Adult Participants
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
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, MD 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 Healthy Adults and Atopic Dermatitis, 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 3 inclusion and 5 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 20 Apr 2022. 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?
Evaluation of gas exudates (time frame: 20 minutes). The study lists 2 primary outcomes in all. 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 20 Apr 2022.