Hydration Sensor for Atopic Dermatitis

May 4, 2023 updated by: Shuai (Steve) Xu, Northwestern University

Validation of Skin Hydration Sensor for Atopic Dermatitis

Pilot study of a soft, flexible hydration sensor

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

172

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

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • 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

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Healthy, aged matched controls or children with prior diagnosis of atopic dermatitis as confirmed by clinical diagnosis by a board-certified dermatologist

Description

Inclusion Criteria:

  • Children <18 years of age
  • Children with new or prior atopic dermatitis diagnosis
  • English speaking
  • Children who are healthy, aged matched controls

Exclusion Criteria:

  • Individuals who are pregnant

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Atopic Dermatitis
Evaluate sensor performance for hydration sensing.
Device: Hydration Sensor
This device includes a hydration sensor embedded within silicone and applied to the skin with a medical grade adhesive.
Healthy aged matched controls
Evaluate sensor performance for hydration sensing.
Device: Hydration Sensor
This device includes a hydration sensor embedded within silicone and applied to the skin with a medical grade adhesive.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Agreement
Time Frame: 1 hour
Percent agreement between experimental sensor and commercially available transepidermal water loss meter.
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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)

November 25, 2019

Primary Completion (Actual)

May 12, 2021

Study Completion (Actual)

February 28, 2023

Study Registration Dates

First Submitted

January 20, 2019

First Submitted That Met QC Criteria

January 20, 2019

First Posted (Actual)

January 23, 2019

Study Record Updates

Last Update Posted (Estimate)

May 5, 2023

Last Update Submitted That Met QC Criteria

May 4, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SX08152018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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