NCT03813472

Brief Summary

Pilot study of a soft, flexible hydration sensor

Trial Health

87
On Track

Trial Health Score

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

Enrollment
172

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 23, 2019

Completed
10 months until next milestone

Study Start

First participant enrolled

November 25, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2021

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
Last Updated

May 6, 2023

Status Verified

May 1, 2023

Enrollment Period

1.5 years

First QC Date

January 20, 2019

Last Update Submit

May 4, 2023

Conditions

Atopic DermatitisHealthy Children

Outcome Measures

Primary Outcomes (1)

  • Percent Agreement

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

    1 hour

Study Arms (2)

Atopic Dermatitis

Evaluate sensor performance for hydration sensing.

Device: Hydration Sensor

Healthy aged matched controls

Evaluate sensor performance for hydration sensing.

Device: Hydration Sensor

Interventions

Hydration SensorDEVICE

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

Atopic DermatitisHealthy aged matched controls

Eligibility Criteria

AgeUp to 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • Individuals who are pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, 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

    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 20, 2019

First Posted

January 23, 2019

Study Start

November 25, 2019

Primary Completion

May 12, 2021

Study Completion

February 28, 2023

Last Updated

May 6, 2023

Record last verified: 2023-05

Locations

US(1)