Psoriasis VulgarisNCT07495657
Pre-Post Multimodal Assessment Of Severe Psoriasis Vulgaris Using Clinical, Dermoscopic And QoL Measures
An observational study of Psoriasis Vulgaris, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Psoriasis Vulgaris
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 1 Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- • Non cooperative patients .
- Pregnant or breastfeeding women
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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).
Read the 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.
- Conditions
- Psoriasis Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Psoriasis Area and Severity Index (PASI)
Change in PASI score from baseline to week 12 and week 24.
Measured: 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.
Measured: Baseline (Day 0), Week 12, Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 May 2026 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis VulgarisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Walid Ibrahim Sultan, Assiut University
- Investigators
- Alaa W Ibrahim, Resident, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07495657
- Sponsor's protocol ID
- Psoriasis Before and After Tx
- Status last verified
- Mar 2026
- First submitted
- 19 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Evaluation of Severe Psoriasis Vulgaris Before and After Treatment Using Clinical, Dermoscopic, Psoriasis Disability Index, and Quality of Life Parameters
- ClinicalTrials.gov ID
- NCT07495657
- Acronym / sponsor ID
- Psoriasis Before and After Tx
- Conditions
- Psoriasis Vulgaris
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- Patients ≥ 6 years of age
Key exclusion criteria (2 listed)
- • Non cooperative patients .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alaa W Ibrahim, Resident principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis Vulgaris, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alaa W Ibrahim, Resident (+2001090130838, dralaawalid310@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Psoriasis Area and Severity Index (PASI) (time frame: Baseline (Day 0) and at week (12), (24)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.