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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6+
SponsorAssiut University

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 .

Disqualifiers

• Non cooperative patients .

Pregnant or breastfeeding women

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

45 Participants
are grouped into 1 trial group
Group A: Severe Psoriasis Cohort

Trial outcomes

Primary outcomes

1

Reduction in Psoriasis Area and Severity Index (PASI)

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

Time frame
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)

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.

Time frame
Baseline (Day 0), Week 12, Week 24

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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