Tokyo, Feb. 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060589) titled 'PsychOsociaL Disease BUrden in PaTIents with PsOriasis Vulgaris in JapaN Quantitative Study of Psychosocial Burden' on Feb. 16.

Study Type: Others,meta-analysis etc

Primary Sponsor: Institute - AbbVie GK

Condition: Condition - Psoriasis Vulgaris Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To develop and validate a comprehensive questionnaire tailored to quantify these psychosocial domains in patients with psoriasis and to implement the validated questionnaire and to use the validated questionnaire with stratified sampling to analyze the psychosocial impact on a larger patient population Basic objectives2 - Others

Eligibility: Age-lower limit - 15 years-old = Gender - Male and Female Key inclusion criteria - - Age at enrollment 15-80 years - Received a diagnosis of mild-to-severe psoriasis vulgaris (patient self-reported) - Must live in Japan and be able to communicate in Japanese - Capable of providing consent to participate in the study - (For surveys) Must be able to answer online questions - For participants below 18 years, availability of parents or legal guardians who can sit next to the participants during survey. Parents or legal guardians could enter the enter the answers to the question forms on behalf of the participants, if participants sit next to them and answer vocally. Key exclusion criteria - - Less than 15 years of age or more than 80 years of age - Patients with a previous diagnosis of PsA - Patients exhibiting any joint symptoms - Patients who have previously experienced any joint symptoms - For participants below 18 years, unavailability of parents or legal guardians who can sit next to the participants during survey. In addition, the following exclusion criteria apply to Steps 2A and 2B, respectively: - Step 2A Pre-test: Unable to attend, understand, and respond to questions posed during an audio-recorded interview conducted using online meeting platform - Step 2A Pilot-test and 2B: Unable to access the online questionnaire and respond to questions Target Size - 423

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 12 Month 25 Day Date of IRB - 2026 Year 01 Month 20 Day Anticipated trial start date - 2026 Year 02 Month 16 Day Last follow-up date - 2026 Year 10 Month 09 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069262

Disclaimer: Curated by HT Syndication.