NCT03874039

Brief Summary

Pilot study of a wearable gas and sweat skin sensor

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2019

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 14, 2019

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2021

Completed
Last Updated

April 20, 2022

Status Verified

April 1, 2022

Enrollment Period

2.6 years

First QC Date

January 29, 2019

Last Update Submit

April 19, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Evaluation of gas exudates

    Evaluation of protein contents from gas exudates from the skin

    20 minutes

  • Evaluation of sweat proteins

    Evaluation of protein contents from sweat from the skin

    20 minutes

Study Arms (2)

Healthy Adults

Healthy adults with no prior diagnosis of atopic dermatitis

Device: Gas sensorDevice: Sweat Sensor

Atopic Dermatitis

Adults with prior diagnosis of Atopic Dermatitis from board certified dermatologist

Device: Gas sensorDevice: Sweat Sensor

Interventions

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.

Atopic DermatitisHealthy Adults

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 DermatitisHealthy Adults

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy adults and adults with prior diagnosis of atopic dermatitis from made by board certified dermatologist

You may qualify if:

  • Age ≥18 years old
  • Subjects willing and able to comply with requirements of the protocol
  • Healthy adults or subjects with atopic dermatitis

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Chicago, Illinois, 60610-5402, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Shuai Xu, MD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 29, 2019

First Posted

March 14, 2019

Study Start

January 15, 2019

Primary Completion

August 10, 2021

Study Completion

August 10, 2021

Last Updated

April 20, 2022

Record last verified: 2022-04

Locations