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The Impact of Pediatric Skin Disorders: The Big Study

The Impact of Pediatric Skin Disorders: The Big Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03544866
Enrollment
1666
Registered
2018-06-04
Start date
2018-11-16
Completion date
2022-01-31
Last updated
2022-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pediatric Skin Conditions

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.

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.

Interventions

None listed

Sponsors

Pediatric Dermatology Research Alliancce
CollaboratorUNKNOWN
Regeneron Pharmaceuticals
CollaboratorINDUSTRY
Immunex Corporation
CollaboratorINDUSTRY
Northwestern University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
8 Years to 17 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Measure the stigma experienced by children as a function of the child's perceived skin lesion visibility using the altered Neuro-QoL stigma toolPast 7 daysMeasure the stigma experienced by children as a function of the child's perceived skin lesion visibility using the altered Neuro-QoL stigma tool

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026