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

NCT07495657 | Not Yet Recruiting

• 1 other identifier: Psoriasis Before and After Tx
• Study Type: observational
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Psoriasis Vulgaris

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Improvement in Dermoscopic Features, Change in Psoriasis Disability Index (PDI), and Change in Dermatology Life Quality Index (DLQI)

  Baseline (Day 0), Week 12, Week 24

Study Arms (1)

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.

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Non cooperative patients .
• Pregnant or breastfeeding women

Sponsors & Collaborators

• Assiut University: lead

Study Officials

• Alaa W Ibrahim, Resident

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alaa W Ibrahim, Resident

CONTACT

+2001090130838; dralaawalid310@gmail.com

Islam A Mahmoud, Resident

CONTACT

+2001129198914; Islam.16266328@med.aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: March 19, 2026
• First Posted: March 27, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share