Department of Dermatology, Northwestern University Feinberg School of Medicine and Lurie Children's Hospital
Chicago, Illinois, 60611, United States
Completed
NCT Number: NCT03544866
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.
Completed
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Conditions
Age range
8 year–17 year
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
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
Sponsors and collaborators
Lead sponsor
Northwestern University
Other
Collaborators
- Immunex Corporation
- Pediatric Dermatology Research Alliancce
- Regeneron Pharmaceuticals
Registry information
Important dates
- Study start
- 2018
- Primary completion
- 2021
- Study completion
- 2022
- First posted
- Jun 4, 2018
- Registry last updated
- Apr 6, 2022
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.