PsoriasisNCT03889938
Serum Level of Bioactive Mediators and Urinary Biopyrins in Psoriasis
An observational study of Psoriasis, run by Assiut University.
Trial summary
1. Assess the level of lipid mediators in patients with psoriasis 2. Assess the urinary level of biopyrins as New marker of oxidative stress in patients with psoriasis 3. Correlate the serum level of bioactive lipid mediators and urinary level of biopyrins with Psoriasis Area and Severity Index Read more about this study
- Who is it for?
- Ages 12 to 80 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- Serum and urinary assessment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2019to May 2020
- Phase
- Observational
- 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 12 to 80 years
- All sexes
- Child, Adult, Older adult
Study population: All patients with psoriasis
Who may be able to join
- age from12 to 80 and both sex
Who cannot join
- patients with other dermatological disorders
Trial locations and contacts
No sites are listed yet.
Eman Kamal, Ass prof contact
About this study
- Assess the level of lipid mediators in patients with psoriasis
- Assess the urinary level of biopyrins as New marker of oxidative stress in patients with psoriasis
- Correlate the serum level of bioactive lipid mediators and urinary level of biopyrins with Psoriasis Area and Severity Index
Read the detailed description
Psoriasis is acommon immune mediated inflammatory skin disorder of complex pathomechanisms which is generically conditioned and influenced by environmental factors
- Conditions
- Psoriasis
- Being tested
- Serum and urinary assessment
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum and urinary assessmentDiagnostic test
Assess bioactive lipid mediators in blood and biopyrins in urine
What is being measured
The primary outcome is the main question the study is designed to answer.
the serum level of bioactive lipid mediators in patients with psoriasis
Bioactive lipid mediators (LMs) are potent compounds reported to play a role in the development and resolution of inflammation.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start1 Apr 2019 (estimated)
- Primary completionApr 2020 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shimaa Mahrous, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03889938
- Sponsor's protocol ID
- BMP
- Status last verified
- Mar 2019
- First submitted
- 22 Mar 2019
- Last updated
- 26 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sorokin AV, Domenichiello AF, Dey AK, Yuan ZX, Goyal A, Rose SM, Playford MP, Ramsden CE, Mehta NN. Bioactive Lipid Mediator Profiles in Human Psoriasis Skin and Blood. J Invest Dermatol. 2018 Jul;138(7):1518-1528. doi: 10.1016/j.jid.2018.02.003. Epub 2018 Feb 15.
PubMed 29454560Bakry OA, El Hefnawy S, Mariee AH, El Gendy Y. Urinary Biopyrrins: A New Marker of Oxidative Stress in Psoriasis. Indian J Dermatol. 2016 Mar-Apr;61(2):169-73. doi: 10.4103/0019-5154.177756.
PubMed 27057016
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Level of Bioactive Mediators and Urinary Biopyrins in Psoriasis
- ClinicalTrials.gov ID
- NCT03889938
- Acronym / sponsor ID
- BMP
- Conditions
- Psoriasis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (estimated)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 26 Mar 2019 (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.
- Assess the level of lipid mediators in patients with psoriasis
- Assess the urinary level of biopyrins as New marker of oxidative stress in patients with psoriasis
- Correlate the serum level of bioactive lipid mediators and urinary level of biopyrins with Psoriasis Area and Severity Index
Detailed description
Psoriasis is acommon immune mediated inflammatory skin disorder of complex pathomechanisms which is generically conditioned and influenced by environmental factors
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 12 to 80 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with psoriasis
Key inclusion criteria (1 listed)
- age from12 to 80 and both sex
Key exclusion criteria (1 listed)
- patients with other dermatological disorders
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 and urinary assessmentAssess bioactive lipid mediators in blood and biopyrins in urine | Diagnostic test | – |
Primary outcome
the serum level of bioactive lipid mediators in patients with psoriasis
Time frame: 1 month
Bioactive lipid mediators (LMs) are potent compounds reported to play a role in the development and resolution of inflammation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2019.
- Background: PubMed 29454560Sorokin AV, Domenichiello AF, Dey AK, Yuan ZX, Goyal A, Rose SM, Playford MP, Ramsden CE, Mehta NN. Bioactive Lipid Mediator Profiles in Human Psoriasis Skin and Blood. J Invest Dermatol. 2018 Jul;138(7):1518-1528. doi: 10.1016/j.jid.2018.02.003. Epub 2018 Feb 15.
- Background: PubMed 27057016Bakry OA, El Hefnawy S, Mariee AH, El Gendy Y. Urinary Biopyrrins: A New Marker of Oxidative Stress in Psoriasis. Indian J Dermatol. 2016 Mar-Apr;61(2):169-73. doi: 10.4103/0019-5154.177756.
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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.
Eman Kamal, Ass prof contact
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis, 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 1 inclusion and 1 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 26 Mar 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shimaa Mahrous (01011845338, shimaamahrous9@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the serum level of bioactive lipid mediators in patients with psoriasis (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03889938, which also lists 2 linked publications.
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 26 Mar 2019.