- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03874039
Sweat and Gas Sensor for Healthy Skin and Atopic Dermatitis
April 19, 2022 updated by: Shuai (Steve) Xu, Northwestern University
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
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60610-5402
- Northwestern University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Healthy adults and adults with prior diagnosis of atopic dermatitis from made by board certified dermatologist
Description
Inclusion Criteria:
- Age ≥18 years old
- Subjects willing and able to comply with requirements of the protocol
- Healthy adults or subjects with atopic dermatitis
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Healthy Adults
Healthy adults with no prior diagnosis of atopic dermatitis
|
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.
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.
|
|
Atopic Dermatitis
Adults with prior diagnosis of Atopic Dermatitis from board certified dermatologist
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluation of gas exudates
Time Frame: 20 minutes
|
Evaluation of protein contents from gas exudates from the skin
|
20 minutes
|
|
Evaluation of sweat proteins
Time Frame: 20 minutes
|
Evaluation of protein contents from sweat from the skin
|
20 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Shuai Xu, MD, Northwestern University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 15, 2019
Primary Completion (Actual)
August 10, 2021
Study Completion (Actual)
August 10, 2021
Study Registration Dates
First Submitted
January 29, 2019
First Submitted That Met QC Criteria
March 13, 2019
First Posted (Actual)
March 14, 2019
Study Record Updates
Last Update Posted (Actual)
April 20, 2022
Last Update Submitted That Met QC Criteria
April 19, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SX09092018
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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