Assessment of Psoriasis Severity in Brazilians Patients With Chronic Plaque-type Psoriasis Attending Outpatient Clinics: a Multicenter, Observational, and Cross-sectional Study (APPISOT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,131
- 主要终点
- Participant's Psoriasis Severity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant diagnosed with chronic plaque psoriasis
- •Participant is at least 18 years old
- •Participant is able to understand and sign the Informed Consent Form
排除标准
- •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
结局指标
主要结局
Participant's Psoriasis Severity
时间窗: At single study visit anytime between 6 to 12 months
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).
次要结局
- Participant Current Psoriasis Severity(At single study visit anytime between 6 to 12 months)
- Disease Duration(Time from disease diagnosis to inclusion (up to 12 months))
- Hospital Anxiety and Depression Scale (HADS) Score(At single study visit anytime between 6 to 12 months)
- Brief Pain Inventory (BPI) Scale Score(At single study visit anytime between 6 to 12 months)
- Health Related Quality of Life (HRQoL) Score(At single study visit anytime between 6 to 12 months)
- Number of Participants With Alcohol Abuse(At single study visit anytime between 6 to 12 months)
- Number of Participants With Comorbidities(At single stuy visit anytime between 6 to 12 months)