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

Chronic Pediatric Skin Conditions Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03544866
• Other study ID #: ASP02172016
• Status: Completed
• Start date: November 16, 2018
• Est. completion date: January 31, 2022

Study information

• Verified date: April 2022
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1666
• Est. completion date: January 31, 2022
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pediatric Skin Conditions
• Skin Diseases

Locations

Country	Name	City	State
United States	Department of Dermatology, Northwestern University Feinberg School of Medicine and Lurie Children's Hospital	Chicago	Illinois

Sponsors (4)

Lead Sponsor	Collaborator
Northwestern University	Immunex Corporation, Pediatric Dermatology Research Alliancce, Regeneron Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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