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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03874039
Other study ID # SX09092018
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 15, 2019
Est. completion date August 10, 2021

Study information

Verified date April 2022
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Pilot study of a wearable gas and sweat skin sensor


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date August 10, 2021
Est. primary completion date August 10, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Device:
Gas sensor
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 Sensor
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.

Locations

Country Name City State
United States Northwestern University Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluation of gas exudates Evaluation of protein contents from gas exudates from the skin 20 minutes
Primary Evaluation of sweat proteins Evaluation of protein contents from sweat from the skin 20 minutes
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