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

Psoriasis Clinical Trial

Official title:

Assessment of Psoriasis Severity in Brazilians Patients With Chronic Plaque-type Psoriasis Attending Outpatient Clinics: a Multicenter, Observational, and Cross-sectional Study (APPISOT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02274363
• Other study ID #: CR100727
• Secondary ID: CNTO1275PSY0001
• Status: Completed
• Phase: N/A
• First received: October 22, 2014
• Last updated: March 23, 2017
• Start date: April 10, 2012
• Est. completion date: May 31, 2013

Study information

• Verified date: March 2017
• Source: Janssen Pharmaceutica
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1131
• Est. completion date: May 31, 2013
• Est. primary completion date: May 31, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Plaque
• Psoriasis

Intervention

Other:
• No Intervention
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Pharmaceutica

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	At single study visit anytime between 6 to 12 months
Secondary	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.	At single study visit anytime between 6 to 12 months
Secondary	Disease Duration	Disease duration is the time from disease diagnosis to inclusion in the study.	Time from disease diagnosis to inclusion (up to 12 months)
Secondary	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.	At single study visit anytime between 6 to 12 months
Secondary	Brief Pain Inventory (BPI) Scale Score	The presence of pain or discomfort over the past week will be assessed using the BPI. The BPI consists of 9 items related to pain (items 3 to 6) and the impact of pain/discomfort (items 9a to 9g) on general activity, mood, walking ability, work, relations with others, sleep and enjoyment of life. Each item is assessed on an 11-point scale varying from zero (no pain or no impact) to 10 (worst possible pain/worst possible impact). The items cover the dimensions of pain/discomfort severity and impact, and the scores are calculated from the means of each item, and may range from 0 to 10. The higher the score, the worse is the pain/discomfort and the perceived impact.	At single study visit anytime between 6 to 12 months
Secondary	Health Related Quality of Life (HRQoL) Score	The HRQoL will be assessed using 36-Item Short-Form Health Survey (SF-36), to assess global HRQoL; and the Dermatology Life Quality Index (DLQI) to assess quality of life specifically related to dermatological conditions. The SF-36 comprises 36 questions divided in 8 domains: physical functioning (10 items), role-physical (4 items), bodily pain (2 items), general health (5 items), vitality (4 items), social functioning (2 items), role-emotional (3 items), mental health (5 items), and a question for comparative assessment of current health status with that of the previous year. The domain-specific scores range from 0 (worst status) to 100 (best status). 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.	At single study visit anytime between 6 to 12 months
Secondary	Number of Participants With Alcohol Abuse	Disorders related to alcohol abuse will be investigated using the cut down, annoyed by criticism, guilty and eye-opener (CAGE) questionnaire. CAGE is a brief questionnaire that comprises four questions to be answered affirmatively or negatively. Two affirmative answers warrant a screening for alcohol abuse or dependence.	At single study visit anytime between 6 to 12 months
Secondary	Number of Participants With Comorbidities	Comorbidity refers to the presence of co-existing or additional diseases with reference to an initial diagnosis or with reference to the index condition that is the subject of study. Participants with Crohn's disease, systemic arterial hypertension, hyperlipidemia, arthritis, obesity, pruritus/burning sensation, depression, ulcerative colitis, metabolic syndrome, neoplasia, diabetes mellitus, ischemic disease and other cardiovascular disorders will be reported.	At single stuy visit anytime between 6 to 12 months