A Study to Assess the Severity of Psoriasis in Brazilians Participants With Chronic Plaque-type Psoriasis

Janssen Pharmaceutica1,131 enrolled

Overview

The purpose of this study is to assess the severity of plaque-type psoriasis (common genetically determined, chronic, inflammatory skin disease characterized by rounded erythematous, dry, scaling patches. The lesions have a predilection for nails, scalp, genitalia, extensor surfaces, and the lumbosacral region) in brazilian participants with chronic plaque-type psoriasis.

This is a cross-sectional (studies in which the presence or absence of disease or other health-related variables are determined in each member of the study population or in a representative sample at one particular time), observational (clinical study in which participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to specific interventions), non-interventional, multicenter study (when more than one hospital or medical school team work on a medical research study). Participants with plaque psoriasis will be followed up at specialized dermatology centers. Participants will undergo assessment at a single time point and all assessments will be conducted on the same day. Information will be collected about disease severity/ socioeconomic variables and demographics; clinical characteristics; treatment (current and past procedures and therapies to treat psoriasis); quality of life; and comorbidities identified after plaque psoriasis was diagnosed. The information will be obtained from the medical records, as requested, and during the medical interviews. The primary objective of this study is to assess the severity of plaque-type psoriasis.

Study Type

OBSERVATIONAL

Enrollment

1,131

Conditions

Psoriasis Plaque

Interventions

No InterventionOTHER

Participants will not receive any intervention in this study. Participants with chronic plaque type psoriasis will be assessed at a single time point, primarily for severity of plaque-type psoriasis Participants will not be followed over time. Data will be collected from the medical consultation notes, medical records and during interviews.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participant diagnosed with chronic plaque psoriasis * Participant is at least 18 years old * Participant is able to understand and sign the Informed Consent Form Exclusion Criteria: * In the opinion of the investigator, the participant is unable or unavailable to complete all study procedures * Participant suffers from a psychiatric condition or any other clinical condition that might interfere with the ability to understand the study requirements * Participant refuses consent or is unwilling to supply the required information within the required period * Participant is taking part in an interventionist clinical trial with an investigational agent (i.e. non-commercialized agent) or in an interventionist clinical trial sponsored by Johnson \& Johnson * Participant is an employee of the investigator or study site and is directly involved in the conduction of this study or other studies conducted by the same investigator at the same site, or is a family member of the employee or investigator

Locations (16)

Unnamed facility

Belém, Brazil

Unnamed facility

Belo Horizonte, Brazil

Unnamed facility

Botucatu, Brazil

Unnamed facility

Outcomes

Primary Outcomes

Participant's Psoriasis Severity

Psoriasis severity will be graded as mild or moderate to severe based on psoriasis area and severity index (PASI) score;combined assessment of lesion severity and area affected into single score. Body will be divided into 4 sections:head, arms, trunk, and legs. For each section, percent (%) area of skin involved was estimated:0=0%, 1=less than (\<) 10%, 2=10 to \<30%, 3=30 to \<50%, 4=50 to \<70%, 5=70 to \<90%, 6=90 to 100%. Severity will be estimated by clinical signs:erythema,induration,desquamation;scale:0= none to 4=maximum. Final PASI=sum of severity parameters for each section\*area score\*weight of section (head:0.1,arms:0.2,body:0.3,legs:0.4);total possible score range: 0=no disease to 72=maximal disease or on the dermatology life quality index (DLQI);comprises 10 questions evaluated on a scale from 0 (not at all) to 3 (very much). The total scores may range from 0 to 30, with higher scores indicating a higher level of disability or on body surface area (BSA).

Time frame: At single study visit anytime between 6 to 12 months

Secondary Outcomes

Participant Current Psoriasis Severity

Psoriasis severity will be graded as mild or moderate to severe based on psoriasis area and severity index (PASI) score or on the dermatology life quality index (DLQI) or on body surface area (BSA). Participants with a score greater than (\>) 10 in any of these scales will be reported as moderate to severe psoriasis. Participants with a PASI score less than or equal to (\<=) 10 will be reported as mild psoriasis. Assessment should consider the participant's status at inclusion.

Time frame: At single study visit anytime between 6 to 12 months

Disease Duration

Disease duration is the time from disease diagnosis to inclusion in the study.

Time frame: Time from disease diagnosis to inclusion (up to 12 months)

Hospital Anxiety and Depression Scale (HADS) Score

The HADS has been developed to identify symptoms of anxiety and depression in hospitalized participants and in outpatients. It comprises 14 items, seven to assess anxiety (HADS-A), namely items 1, 3, 5, 7, 9, 11, and 13; and seven to assess depression (HADS-D), namely items 2, 4, 6, 8, 10, 12, and 14. Each item receives a score from 0 to 3 on a Likert Scale. The total score for each scale is obtained by adding the individual scores for each item, with the maximum score 21. The presence or absence of depression and anxiety will be defined, for each respective scale, based on the following cutoff values: HADS (anxiety): 0-8 = no anxiety; \>9 = anxiety; HADS (depression): 8-8 = no depression; \>9 = depression.

Data from ClinicalTrials.gov

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