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Clinical Trials/NCT03544866
NCT03544866
Completed
N/A

The Impact of Pediatric Skin Disorders: The "Big" Study

Northwestern University1 site in 1 country1,666 target enrollmentNovember 16, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Chronic Pediatric Skin Conditions
Sponsor
Northwestern University
Enrollment
1666
Locations
1
Primary Endpoint
Measure the stigma experienced by children as a function of the child's perceived skin lesion visibility using the altered Neuro-QoL stigma tool
Status
Completed
Last Updated
4 years ago

Overview

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.

Detailed Description

This is a multi center study with Northwestern University/Lurie Children's Hospital serving as the Data Coordinating Center. Site selection has been completed through members of PeDRA.

Registry
clinicaltrials.gov
Start Date
November 16, 2018
End Date
January 31, 2022
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Amy Paller

Principal Investigator

Northwestern University

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

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

Time Frame: Past 7 days

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

Study Sites (1)

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