Pre-Post Multimodal Assessment Of Severe Psoriasis Vulgaris Using Clinical, Dermoscopic And QoL Measures
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Psoriasis Vulgaris. Basic parameters: from 6 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Multimodal Evaluation of Severe Psoriasis Vulgaris Before and After Treatment Using Clinical, Dermoscopic, Psoriasis Disability Index, and Quality of Life Parameters
Overview
The goal of this observational study is to learn about the comprehensive changes in severe plaque psoriasis (Psoriasis Vulgaris) in adult participants undergoing standard treatment. The main questions it aims to answer are: How clinical signs of psoriasis, such as redness, scaling, and thickness, change after treatment? How specific skin features, visualized under dermoscopy, change after treatment? How participants' perceptions of psoriasis-related disability and overall quality of life improve after treatment? Participants will undergo standard medical treatment for severe psoriasis. Participants will be evaluated at the beginning of the study and again after treatment using clinical skin examinations, dermoscopic imaging, and validated questionnaires (Psoriasis Disability Index and quality of life parameters).
Detailed description
Two to three percent of people have psoriasis, a persistent immune-mediated condition. Mostly presenting as scaly, inflammatory skin plaques, it is a systemic disorder that is also associated with metabolic syndrome, fatty liver disease, cardiovascular issues, and joint inflammation (psoriatic arthritis). Nowadays, the PASI (Psoriasis Area and Severity Index) is frequently used extensively in clinical evaluation and studies. This score measures the body surface area affected and the redness, thickness, and scaling of plaques, but it is somewhat subjective and can miss how the disease truly affects a patient's life. To obtain a more complete and balanced assessment, the investigators propose integrating five complementary tools: A clinician-based tool: The BSA and PASI score, which provide a standardized clinical measure. An objective tool: Dermoscopy (magnified skin surface imaging to visualize microscopic blood vessels and structures).
A patient-based tools: Psoriasis Disability Index (PDI) is a validated, psoriasis-specific quality of life questionnaires (15-item) that assesses the impact of psoriasis on patient functioning across five domains: daily activities, employment, personal relationships, leisure, and treatment effects and Quality of Life (QoL) Questionnaires that assesses the psychological, social, and personal impact of the disease.
What are the clinical, dermoscopic, psoriasis disability index, and quality-of-life characteristics of participants with severe Psoriasis Vulgaris before and after systemic treatment? These tools are frequently utilized separately in modern practice, with PASI serving as the main focus. This can lead to a narrow definition of treatment success. A combined, multimodal approach is designed to bridge this gap. It seeks to establish a correlation between the participant's lived experience (QoL, PDI) and objective tissue evidence (dermoscopy) and the physician's clinical observation (PASI, BSA). This combined approach solves the problem of single-method check-ups. By looking at everything at once, it can find early signs that treatment is working, catch disease activity that visual exams miss, and make sure successful treatment means both healthy skin and a better life for the participant.
Primary outcome measures
- Reduction in Psoriasis Area and Severity Index (PASI) [Time frame: Baseline (Day 0) and at week (12), (24)]
Secondary outcome measures (1)
- Improvement in Dermoscopic Features, Change in Psoriasis Disability Index (PDI), and Change in Dermatology Life Quality Index (DLQI) [Time frame: Baseline (Day 0), Week 12, Week 24]
Eligibility criteria
Inclusion criteria
- Patients ≥ 6 years of age
- Newly diagnosed patients with plaque psoriasis with affected BSA >10%
- Indicated for a new systemic therapy (e.g., oral agent, biologics).
- Willing and able to provide informed consent for all procedures .
- At least one eligible, representative target plaque for serial dermoscopic imaging .
- Stop previous systemic therapy at least 2-3 months
Exclusion criteria
- • Non cooperative patients .
- Pregnant or breastfeeding women
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07495657 · Psoriasis Before and After Tx