Pre-Post Multimodal Assessment Of Severe Psoriasis Vulgaris Using Clinical, Dermoscopic And QoL Measures

Multimodal Evaluation of Severe Psoriasis Vulgaris Before and After Treatment Using Clinical, Dermoscopic, Psoriasis Disability Index, and Quality of Life Parameters

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Psoriasis Vulgaris

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.

• Study Type: Observational
• Enrollment (Estimated): 45

Contacts and Locations

• Study Contact: Name: Alaa W Ibrahim, Resident; Phone Number: +2001090130838; Email: dralaawalid310@gmail.com
• Study Contact Backup: Name: Islam A Mahmoud, Resident; Phone Number: +2001129198914; Email: Islam.16266328@med.aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients of both genders with severe chronic plaque psoriasis who are candidates for or about to initiate systemic treatment (conventional or biologic). Recruited from dermatology outpatient clinic. Severe psoriasis defined as PASI >10 and/or BSA >10% and/or DLQI >10. Patients undergo clinical exam, dermoscopic imaging, and complete Psoriasis Disability Index and Quality of Life questionnaires at baseline, 3, and 6 months post-treatment. Excluded: patients on topical therapy only, pregnant/lactating women, and those with significant comorbidities interfering with assessments

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Severe Psoriasis Cohort; patients with severe chronic plaque psoriasis receiving systemic treatment (conventional or biologic therapy) as part of their routine clinical care. Participants undergo clinical evaluation (PASI, BSA), dermoscopic imaging, and complete Psoriasis Disability Index (PDI) and Dermatology Life Quality Index (DLQI) questionnaires at baseline and at 3 and 6 months following treatment initiation. No experimental interventions are administered; patients receive standard prescribed treatment per their dermatologist's clinical judgment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in Psoriasis Area and Severity Index (PASI)	Change in PASI score from baseline to week 12 and week 24.	Baseline (Day 0) and at week (12), (24)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in Dermoscopic Features, Change in Psoriasis Disability Index (PDI), and Change in Dermatology Life Quality Index (DLQI)	Assessment of changes in dermoscopic vascular patterns from baseline to week 12 and week 24, Change in PDI score from baseline to week 12 and week 24 and Change in DLQI score from baseline to week 12 and week 24.	Baseline (Day 0), Week 12, Week 24

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Alaa W Ibrahim, Resident, Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: March 19, 2026
• First Submitted That Met QC Criteria: March 24, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: Psoriasis Before and After Tx

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No