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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pediatric Skin Conditions

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 Type: Observational
• Enrollment (Actual): 1666

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Department of Dermatology, Northwestern University Feinberg School of Medicine and Lurie Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: Regeneron Pharmaceuticals; Immunex Corporation; Pediatric Dermatology Research Alliancce
• Investigators: Principal Investigator: Amy Paller, Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2018
• Primary Completion (Actual): May 31, 2021
• Study Completion (Actual): January 31, 2022

Study Registration Dates

• First Submitted: May 22, 2018
• First Submitted That Met QC Criteria: May 22, 2018
• First Posted (Actual): June 4, 2018

Study Record Updates

• Last Update Posted (Actual): April 6, 2022
• Last Update Submitted That Met QC Criteria: April 4, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases
• Other Study ID Numbers: ASP02172016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No