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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03544866
Recruitment Status : Completed
First Posted : June 4, 2018
Last Update Posted : April 6, 2022
Sponsor:
Collaborators:
Pediatric Dermatology Research Alliancce
Regeneron Pharmaceuticals
Immunex Corporation
Information provided by (Responsible Party):
Amy Paller, Northwestern University

Study Description
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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.

Condition or disease
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 Design
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Study Type : Observational
Actual Enrollment : 1666 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Impact of Pediatric Skin Disorders: The "Big" Study
Actual Study Start Date : November 16, 2018
Actual Primary Completion Date : May 31, 2021
Actual Study Completion Date : January 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Conditions

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
3,500 parent/child dyads across all sites (at least 50 parent/child dyads at each site).
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03544866


Locations
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United States, Illinois
Department of Dermatology, Northwestern University Feinberg School of Medicine and Lurie Children's Hospital
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Pediatric Dermatology Research Alliancce
Regeneron Pharmaceuticals
Immunex Corporation
Investigators
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Principal Investigator: Amy Paller Northwestern University
More Information
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Responsible Party: Amy Paller, Principal Investigator, Northwestern University
ClinicalTrials.gov Identifier: NCT03544866    
Other Study ID Numbers: ASP02172016
First Posted: June 4, 2018    Key Record Dates
Last Update Posted: April 6, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Skin Diseases