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

Completed

• Conditions: Chronic Pediatric Skin Conditions

• Registration Number: NCT03544866
• Lead Sponsor: Northwestern University

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.

Study Timeline

• Study First Submitted: 2018-05-22
• Study First Submitted QC: 2018-05-22
• Study First Posted: 2018-06-04
• Study Start: 2018-11-16
• Primary Completion: 2021-05-31
• Study Completion: 2022-01-31
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-04
• Last Update Posted: 2022-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1666

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Department of Dermatology, Northwestern University Feinberg School of Medicine and Lurie Children's Hospital; 🇺🇸 Chicago, Illinois, United States