Developing diagnostic criteria for psoriasis in childre

Not Applicable

Completed

• Conditions: Psoriasis in children and young people; Skin and Connective Tissue Diseases; Psoriasis

• Registration Number: ISRCTN98851260
• Lead Sponsor: niversity of Nottingham

Brief Summary

2019 Protocol article in https://pubmed.ncbi.nlm.nih.gov/31462472/ protocol (added 02/09/2020) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34477218/ (added 30/12/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-11-07
• Study Completion: 2019-08-31
• Last Update Posted: 10 January 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 348

Inclusion Criteria

Cases:
1. Children/young people (0 to <18 years of age)
2. Confirmed diagnosis of plaque psoriasis by a dermatologist
3. Active disease at the time of assessment
4. Able to consent

Controls:
1. Children/young people (0 to <18 years of age)
2. Confirmed diagnosis of a scaly inflammatory rash (excluding psoriasis and indeterminate psoriasis) by a dermatologist
3. Active disease at the time of assessment
4. Able to consent

Indeterminate psoriasis:
1. Children/young people (0 to <18 years of age)
2. Diagnosis of indeterminate or possible psoriasis by a dermatologist
3. Active disease at the time of assessment
4. Able to consent and willing to receive a follow-up questionnaire after 24 months

Exclusion Criteria

1. Children/young people with pustular psoriasis
2. Children/young people with erythrodermic psoriasis
3. Children/young people without a dermatologist’s diagnosis

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Consensus agreed diagnostic criteria vs reference standard (dermatologist’s diagnosis). The presence or absence (binary) of each of the diagnostic criterion will be assessed by study investigators trained to undertake the diagnostic criteria assessment and blinded to the diagnosis of the participant. The threshold for diagnosis according to the consensus agreed diagnostic criteria has been determined through the consensus study. The diagnostic accuracy of the consensus agreed diagnostic criteria will be assessed using sensitivity and specificity. The best predictive diagnostic criteria will be developed using multivariate analysis and the decision to include individual criteria in the model will be based on the likelihood ratio.