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

NCT ID: NCT03544866

Last Updated: 2022-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1666 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-16

Study Completion Date

2022-01-31

Brief Summary

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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

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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.

Conditions

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Chronic Pediatric Skin Conditions

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pediatric Dermatology Research Alliancce

UNKNOWN

Sponsor Role collaborator

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Immunex Corporation

INDUSTRY

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Amy Paller

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amy Paller

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

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

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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ASP02172016

Identifier Type: -

Identifier Source: org_study_id

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