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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03813472
Other study ID # SX08152018
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 25, 2019
Est. completion date February 28, 2023

Study information

Verified date May 2023
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Pilot study of a soft, flexible hydration sensor


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.


Recruitment information / eligibility

Status Completed
Enrollment 172
Est. completion date February 28, 2023
Est. primary completion date May 12, 2021
Accepts healthy volunteers
Gender All
Age group N/A to 18 Years
Eligibility 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 Design


Intervention

Device:
Hydration Sensor
This device includes a hydration sensor embedded within silicone and applied to the skin with a medical grade adhesive.

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 Percent Agreement Percent agreement between experimental sensor and commercially available transepidermal water loss meter. 1 hour
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