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NCT Number: NCT07495657

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

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).

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Key information

Conditions

Age range

6 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Reduction in Psoriasis Area and Severity Index (PASI)

    Time frame: Baseline (Day 0) and at week (12), (24)

    Change in PASI score from baseline to week 12 and week 24.

Secondary outcomes

  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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alaa W Ibrahim, Resident

CONTACT

[email protected]

+2001090130838

Islam A Mahmoud, Resident

CONTACT

[email protected]

+2001129198914

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 27, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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