NCT03544866

Brief Summary

This study leverages the availability of a validated series of instruments to measure the effect of highly visible, chronic skin disorders, including atopic dermatitis (AD), on patients 8 years of age and above in causing stigma and psychiatric issues, particularly anxiety and depression.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,666

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2018

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

May 22, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 4, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

November 16, 2018

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
Last Updated

April 6, 2022

Status Verified

April 1, 2022

Enrollment Period

2.5 years

First QC Date

May 22, 2018

Last Update Submit

April 4, 2022

Conditions

Chronic Pediatric Skin Conditions

Outcome Measures

Primary Outcomes (1)

  • Measure the stigma experienced by children as a function of the child's perceived skin lesion visibility using the altered Neuro-QoL stigma tool

    Measure the stigma experienced by children as a function of the child's perceived skin lesion visibility using the altered Neuro-QoL stigma tool

    Past 7 days

Eligibility Criteria

Age8 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

3,500 parent/child dyads across all sites (at least 50 parent/child dyads at each site).

You may qualify if:

  • Subjects must be aged 8-17 years of age
  • Subject must be diagnosed with a chronic skin disease deemed to be severe enough and/or in a visible location that could be stigmatizing as determined by the study doctor
  • Subject and parent must both be English speaking with at least one parent/guardian who will complete the questionnaires
  • Subject and Parent/Guardian must be able to complete the relevant questionnaires

You may not qualify if:

  • Children under 8 years of age
  • Children with developmental delay and/or a behavioral disorder that would preclude participation in form completion
  • Children with a non-cutaneous disorder that is considered by the Study doctor to be stigmatizing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Dermatology, Northwestern University Feinberg School of Medicine and Lurie Children's Hospital

Chicago, Illinois, 60611, United States

Location

Study Officials

  • Amy Paller

    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

May 22, 2018

First Posted

June 4, 2018

Study Start

November 16, 2018

Primary Completion

May 31, 2021

Study Completion

January 31, 2022

Last Updated

April 6, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)