PsoriasisNCT05252741
Levels of Pigment Epithelium-derived Factor in Patients With Psoriasis.
A study testing serum samples and punch skin biopsies in people with Psoriasis, run by Sohag University at 1 site in Egypt.
Trial summary
Psoriasis is an immune-mediated chronic inflammatory skin disease associated with increase interaction of inflammatory mediators like adipokines. Pigment epithelium-derived factor (PEDF) is one of the most abundant adipokines and have anti-angiogenesis effect. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Psoriasis
- What is being tested?
- serum samples and punch skin biopsies
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Feb 2022to Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with psoriasis and group of age and sex-matched healthy volunteers will be included as a control group.
Who cannot join
- Pregnancy.
- Patients with other inflammatory skin disorders.
- Patients on antioxidants or anti-inflammatory drugs.
- Patients on topical or systemic treatment for psoriasis in the last 4 weeks prior to enrollment in the study.
- Patients on systemic retinoids (Acitretin).
- Obesity: body mass index (BMI ) > 30.
Show all 10Show fewer
- Malignancies e.g squamous cell carcinoma.
- Viral warts.
- Diabetes.
- Hypertension.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine Sohag University
Sohag
Omnia Ahmed, Resident of Dermatology, 01064292851, omnia.mohamed1@med.sohag.edu.eg
About this study
Official title: Evaluation Of Levels Of Pigment Epithelium-Derived Factor (PEDF) In Patients With Psoriasis.
Psoriasis is an immune-mediated chronic inflammatory skin disease associated with increase interaction of inflammatory mediators like adipokines. Pigment epithelium-derived factor (PEDF) is one of the most abundant adipokines and have anti-angiogenesis effect. There is a study showed that PEDF level is up-regulated in the sera of psoriasis patients.
- Conditions
- Psoriasis
- Being tested
- serum samples and punch skin biopsies
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum samples and punch skin biopsiesOther
we will take serum samples from psoriasis patients and healthy controls and skin punch biopsies from lesional and non-lesional areas in psoriasis patients.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: patients with psoriasis | Active comparator | Not described Receives: Other: serum samples and punch skin biopsies |
| Group 2: age-, sex-, BMI-, and weight-matched control subjects. | Placebo comparator | Not described Receives: Other: serum samples and punch skin biopsies |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in serum and tissue levels of (PEDF) in patients with psoriasis
evaluate serum and tissue level of (PEDF) in patients with psoriasis.
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 posted23 Feb 2022
- Study start20 Feb 2022
- Primary completionFeb 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omnia Ahmed Abdelhafez, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05252741
- Sponsor's protocol ID
- soh-Med-22-02-04
- Status last verified
- Mar 2022
- First submitted
- 13 Feb 2022
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of Levels Of Pigment Epithelium-Derived Factor (PEDF) In Patients With Psoriasis.
- ClinicalTrials.gov ID
- NCT05252741
- Acronym / sponsor ID
- soh-Med-22-02-04
- Conditions
- Psoriasis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 20 Feb 2022 (actual)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 23 Feb 2022 (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 an immune-mediated chronic inflammatory skin disease associated with increase interaction of inflammatory mediators like adipokines. Pigment epithelium-derived factor (PEDF) is one of the most abundant adipokines and have anti-angiogenesis effect. There is a study showed that PEDF level is up-regulated in the sera of psoriasis patients.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: patients with psoriasis | Active comparator | Other: serum samples and punch skin biopsies |
| Group 2: age-, sex-, BMI-, and weight-matched control subjects. | Placebo comparator | Other: serum samples and punch skin biopsies |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with psoriasis and group of age and sex-matched healthy volunteers will be included as a control group.
Key exclusion criteria (10 listed)
- Pregnancy.
- Patients with other inflammatory skin disorders.
- Patients on antioxidants or anti-inflammatory drugs.
- Patients on topical or systemic treatment for psoriasis in the last 4 weeks prior to enrollment in the study.
- Patients on systemic retinoids (Acitretin).
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 |
|---|---|---|
| serum samples and punch skin biopsieswe will take serum samples from psoriasis patients and healthy controls and skin punch biopsies from lesional and non-lesional areas in psoriasis patients. | Other | Group 1: patients with psoriasis, Group 2: age-, sex-, BMI-, and weight-matched control subjects. |
Primary outcome
changes in serum and tissue levels of (PEDF) in patients with psoriasis
Time frame: 12 months
evaluate serum and tissue level of (PEDF) in patients with psoriasis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing serum samples and punch skin biopsies in people with Psoriasis, run by Sohag 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 1 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 6 Apr 2022. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Omnia Ahmed, Resident of Dermatology (01064292851, omnia.mohamed1@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in serum and tissue levels of (PEDF) in patients with psoriasis (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 Apr 2022.