Psoriasis VulgarisNCT07320872
Correlation Between Vaspin Gene Polymorphism and Serum Vaspin Levels in Psoriasis Vulgaris
An observational study of Psoriasis Vulgaris, run by Aswan University at 1 site in Egypt.
Trial summary
Psoriasis is a common immune-mediated inflammatory skin disease affecting at least 100 million individuals worldwide. In Egypt, the prevalence of psoriasis ranges between 0.19% and 3% of the Egyptian people. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- vaspin gene polymorphism
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Aug 2025to 20 Aug 2026
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The study will include (30) psoriasis patients and (30) normal control. and will be conducted on psoriasis patients and the healthy persons whom will be selected from the outpatient clinic of the Dermatology, Venereology, and Andrology Department, at Aswan University Hospital.
Who may be able to join
- Newly diagnosed cases or stopped treatment of at least 6 months of psoriasis patients.
- Pateints with any age and gender.
Who cannot join
- Pregnancy and lactation.
- Patients with chronic diseases: cardiac diseases, hepatic disorders, chronic renal failure or malignancies.
- Patients with associated inflammatory disease such as infections and autoimmune diseases.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Aswan University Hospital
Aswān
Mostafa Adam Ali El Taieb, Professor, +201092991101, moustafa.eltaib@aswu.edu.eg
Mohamed Amer Ahmed Abdellatif, Lecturer, +201060394083, mohammed.abdellatif@aswu.edu.eg
About this study
Official title: Correlation Between Vaspin Gene Polymorphism and Serum Vaspin Levels in Psoriasis Vulgaris and Its Relation to Pathogenesis and Risk of the Disease
Psoriasis is a common immune-mediated inflammatory skin disease affecting at least 100 million individuals worldwide. In Egypt, the prevalence of psoriasis ranges between 0.19% and 3% of the Egyptian people.
It is associated with poor quality of life, reduced life expectancy and multimorbidity including psoriatic arthritis, obesity and cardiovascular disease.
Vaspin (VASP, SERPIN 12) is a recently discovered adipokine that has been isolated from the visceral adipose tissue of a rat model of type 2 diabetes. It is coded by the gene SERPNA12 located on the long arm of chromosome 14q32.13 and consists of six exons and five introns.
Read the detailed description
Psoriasis can present at any age. However, the disease onset appears to follow a bimodal distribution, peaking around 20-30 years of age and again around 50-60 years of age.
Psoriasis is a common skin disease characterized clinically by formation of erythematous and scaly plaques at different sites affecting mainly the extensor prominences, scalp, the lumbosacral area and the sites of trauma. It is a lifelong disease with spontaneous remissions and exacerbations.
The exact etiology is unknown, but it is considered to be an autoimmune disease mediated by T lymphocytes. It is considered the most prevalent T-cell-mediated inflammatory disease in human beings, in which, keratinocytes in focal skin regions are stimulated to proliferate with activation of the immune system mediated by primed T-lymphocytes.
There is an association of HLA antigens seen in many psoriatic patients, particularly in various racial and ethnic groups. Familial occurrence suggests its genetic predisposition .
The pathophysiology of psoriasis involves infiltration of the skin by activated T cells which stimulate the proliferation of keratinocytes. This dysregulation in keratinocyte turnover results in the formation of thick plaques. Other associated features include epidermal hyperplasia and parakeratosis. There are several treatment options available for mild psoriasis, including topical corticosteroids, vitamin D analogs, calcineurin inhibitors, keratolytics, and targeted phototherapy.
More severe disease might require systemic therapy, including phototherapy, acitretin, methotrexate, cyclosporine, or biologic therapy. Psoriasis is accompanied by comorbidities such as obesity, diabetes, and metaboloic syndrome. Although the pathogenesis is still unknown, systemic inflammation caused by adipokines released from visceral adipose tissue is thought to play a role .
Adipokines are various bioactive polypeptides produced and released by adipose tissue. Adipokines are thought to play an important role in the pathogenesis of obesity-related diseases such as insulin resistance, hypertension, inflammation, and metabolic disorders.
Vaspin (visceral adipose tissue-derived serine protease inhibitor also called Serpin A12), It belongs to the serpin group of proteins and is a serine protease inhibitor produced from visceral adipose tissue.Vaspin consists of 415 amino acids and weighing 47-kDa .
Vaspin is an adipokine with recently described anti-inflammatory properties. It has been reported to be expressed in various tissues, such as skin, liver, stomach and pancreas, in addition to adipose tissue in humans . The main source of vaspin in human skin was found to be keratinocytes. Vaspin in the skin is associated with the differentiation of keratinocytes and suppresses the expression of inflammatory mediators.
- Conditions
- Psoriasis Vulgaris
- Being tested
- vaspin gene polymorphism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vaspin gene polymorphismBiological
Also called Serum Vaspin Levels
to detect the correlation between vaspin gene polymorphism and serum vaspin levels among psoriasis patients.
- To detect the relationship between the risk of psoriasis and the vaspin gene polymorphism.
- To detect correlation between vaspin gene polymorphism and the severity of psoriasis.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Psoriasis Patients | About 30 patients suffering from Psoriasis Vulgaris will subject to vaspin gene polymorphism measure and Assessment of the disease severity will be performed by using Psoriasis area and severity index score (PASI score) for all patients. Receives: Biological: vaspin gene polymorphism | |
| Group B: Control Group | About 30 healthy participants will share as A control Group Receives: Biological: vaspin gene polymorphism |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of vaspin gene polymorphism
Assessment of vaspin gene polymorphism in psoriasis patients to determine the disease severity
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start10 Aug 2025
- Primary completion10 Aug 2026 (estimated)
- Study completion20 Aug 2026 (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.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aswan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ola Mahmoud Elqousy, Aswan University
- Investigators
- Moustafa Adam Ali El Taieb, Professor, Study chair, Dermatology, Venereology and Andrology.Faculty of Medicine, Aswan UniversityHoda Soltan Sherkawy El Bakry, Lecturer, Study director, Medical biochemistry,Faculty of Medicine,Aswan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07320872
- Sponsor's protocol ID
- Psoriasis Vulgaris Vaspin Gene
- Status last verified
- Aug 2025
- First submitted
- 21 Dec 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Vaspin Gene Polymorphism and Serum Vaspin Levels in Psoriasis Vulgaris and Its Relation to Pathogenesis and Risk of the Disease
- ClinicalTrials.gov ID
- NCT07320872
- Acronym / sponsor ID
- Psoriasis Vulgaris Vaspin Gene
- Conditions
- Psoriasis Vulgaris
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Aswan UniversityUniversity, hospital or other
- Study start
- 10 Aug 2025 (actual)
- Primary completion
- 10 Aug 2026 (estimated)
- Study completion
- 20 Aug 2026 (estimated)
- First posted
- 6 Jan 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.
Psoriasis is a common immune-mediated inflammatory skin disease affecting at least 100 million individuals worldwide. In Egypt, the prevalence of psoriasis ranges between 0.19% and 3% of the Egyptian people.
It is associated with poor quality of life, reduced life expectancy and multimorbidity including psoriatic arthritis, obesity and cardiovascular disease.
Vaspin (VASP, SERPIN 12) is a recently discovered adipokine that has been isolated from the visceral adipose tissue of a rat model of type 2 diabetes. It is coded by the gene SERPNA12 located on the long arm of chromosome 14q32.13 and consists of six exons and five introns.
Detailed description
Psoriasis can present at any age. However, the disease onset appears to follow a bimodal distribution, peaking around 20-30 years of age and again around 50-60 years of age.
Psoriasis is a common skin disease characterized clinically by formation of erythematous and scaly plaques at different sites affecting mainly the extensor prominences, scalp, the lumbosacral area and the sites of trauma. It is a lifelong disease with spontaneous remissions and exacerbations.
The exact etiology is unknown, but it is considered to be an autoimmune disease mediated by T lymphocytes. It is considered the most prevalent T-cell-mediated inflammatory disease in human beings, in which, keratinocytes in focal skin regions are stimulated to proliferate with activation of the immune system mediated by primed T-lymphocytes.
There is an association of HLA antigens seen in many psoriatic patients, particularly in various racial and ethnic groups. Familial occurrence suggests its genetic predisposition .
The pathophysiology of psoriasis involves infiltration of the skin by activated T cells which stimulate the proliferation of keratinocytes. This dysregulation in keratinocyte turnover results in the formation of thick plaques. Other associated features include epidermal hyperplasia and parakeratosis. There are several treatment options available for mild psoriasis, including topical corticosteroids, vitamin D analogs, calcineurin inhibitors, keratolytics, and targeted phototherapy.
More severe disease might require systemic therapy, including phototherapy, acitretin, methotrexate, cyclosporine, or biologic therapy. Psoriasis is accompanied by comorbidities such as obesity, diabetes, and metaboloic syndrome. Although the pathogenesis is still unknown, systemic inflammation caused by adipokines released from visceral adipose tissue is thought to play a role .
Adipokines are various bioactive polypeptides produced and released by adipose tissue. Adipokines are thought to play an important role in the pathogenesis of obesity-related diseases such as insulin resistance, hypertension, inflammation, and metabolic disorders.
Vaspin (visceral adipose tissue-derived serine protease inhibitor also called Serpin A12), It belongs to the serpin group of proteins and is a serine protease inhibitor produced from visceral adipose tissue.Vaspin consists of 415 amino acids and weighing 47-kDa .
Vaspin is an adipokine with recently described anti-inflammatory properties. It has been reported to be expressed in various tissues, such as skin, liver, stomach and pancreas, in addition to adipose tissue in humans . The main source of vaspin in human skin was found to be keratinocytes. Vaspin in the skin is associated with the differentiation of keratinocytes and suppresses the expression of inflammatory mediators.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Psoriasis Patients | – | Biological: vaspin gene polymorphismAbout 30 patients suffering from Psoriasis Vulgaris will subject to vaspin gene polymorphism measure and Assessment of the disease severity will be performed by using Psoriasis area and severity index score (PASI score) for all patients. |
| Group B: Control Group | – | Biological: vaspin gene polymorphismAbout 30 healthy participants will share as A control Group |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study will include (30) psoriasis patients and (30) normal control. and will be conducted on psoriasis patients and the healthy persons whom will be selected from the outpatient clinic of the Dermatology, Venereology, and Andrology Department, at Aswan University Hospital.
Key inclusion criteria (2 listed)
- Newly diagnosed cases or stopped treatment of at least 6 months of psoriasis patients.
- Pateints with any age and gender.
Key exclusion criteria (3 listed)
- Pregnancy and lactation.
- Patients with chronic diseases: cardiac diseases, hepatic disorders, chronic renal failure or malignancies.
- Patients with associated inflammatory disease such as infections and autoimmune diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vaspin gene polymorphismAlso: Serum Vaspin Levelsto detect the correlation between vaspin gene polymorphism and serum vaspin levels among psoriasis patients. * To detect the relationship between the risk of psoriasis and the vaspin gene polymorphism. * To detect correlation between vaspin gene polymorphism and the severity of psoriasis. | Biological | Group A: Psoriasis Patients, Group B: Control Group |
Primary outcome
Detection of vaspin gene polymorphism
Time frame: 12 Months
Assessment of vaspin gene polymorphism in psoriasis patients to determine the disease severity
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 6 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
Moustafa Adam Ali El Taieb, Professor study chair
Dermatology, Venereology and Andrology.Faculty of Medicine, Aswan University
Hoda Soltan Sherkawy El Bakry, Lecturer study director
Medical biochemistry,Faculty of Medicine,Aswan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis Vulgaris, run by Aswan University at 1 site in Egypt.
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 2 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Ola Mahmoud Samy Mohamed, MSC (+201025592922, olaelqousy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of vaspin gene polymorphism (time frame: 12 Months). 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 6 Jan 2026; AzTrials last refreshed its copy on 4 Nov 2026.