PsoriasisPhase 4NCT05203354

Omentin-1 Level in Psoriatic Patients Treated With Narrowband Ultraviolet B Phototherapy Versus Acitretin

A Phase 4 study testing Narrowband Ultraviolet B and Acitretin in people with Psoriasis, run by Mahmoud Ahmed Ali Ahmed at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Studying the effects of Narrowband Ultraviolet B versus acitretin on psoriatic patients Read more about this study

Who is it for?: Ages 20 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Psoriasis
What is being tested?: Narrowband Ultraviolet B and Acitretin
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteEgypt
Study dates: 1 Sep 2018to 15 Aug 2021
Phase: Phase 4
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 20 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Patients of both sexes with psoriasis vulgaris.

Who cannot join

• Patients with history of malignancies, renal and liver diseases.
Patients received NB-UVB phototherapy in the last 6 months.
Patients treated with methotrexate or biologic agents and any systemic treatment of psoriasis.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Faculty of medicine - Aswan university
Aswān, 81528

Other trials in Egypt

About this study

Studying the effects of Narrowband Ultraviolet B versus acitretin on psoriatic patients

Read the detailed description

Compare the effects of Narrowband Ultraviolet B versus acitretin on serum Omentin-1 level in psoriatic patients as case control study by dividing patients into 3 groups: group 1 include patients receive Narrowband Ultraviolet B, group II includes patients receive acitretin (0.5-1 mg/day) and control group. The duration of this study about 3 months after receving those interventions.

Conditions: Psoriasis
Being tested: Narrowband Ultraviolet B, Acitretin
Medical subject headings: Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Narrowband Ultraviolet BRadiation
Also called NB-UVB phototherapy
patients will exposed to sessions of NB-UVB phototherapy twice weekly for 3 months
AcitretinDrug
patients will received acitretin in dose 0.5-1 mg/kg daily for 3 months

Study groups in NCT05203354
Study group	Role	What they receive
NB-UVB group	Active comparator	Patients who receive Narrowband ultraviolet B phototherapy Receives: Radiation: Narrowband Ultraviolet B
Acitretin group	Active comparator	Patients who receive acitretin Receives: Drug: Acitretin
Control group	No intervention	It includes apparently healthy people who will be compared to patients in the measurement of Omentin-1 level

What is being measured

The primary outcome is the main question the study is designed to answer.

Decrease Omentin-1 serum level in both groups treated with NB-UVB and Acitretin
This outcome indicates potential role of Omentin-1 in psoriasis pathogenesis and its involvement in pathogenesis of obesity and related diseases as metabolic syndrome. So it will be concluded that high levels of this protein could be marker against obesity and related disorders including psoriasis. Omentin-1 can be valuable marker for psoriasis severity detected by its correlation with psoriasis area severity index (PASI) score and for evaluating the therapeutic outcomes
Measured: 3 months

Secondary outcomes (1)

Decrease PASI score in psoriatic patients
Decrease in PASI score in psoriatic patients after treatment with NB-UVB acitretin
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 201815 Aug 2021

First posted24 Jan 2022
Study start1 Sep 2018
Primary completion1 May 2021
Study completion15 Aug 2021

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.
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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05203354
Sponsor's protocol ID: 288/9/18
Status last verified: Jan 2022
First submitted: 14 Dec 2021
Last updated: 24 Jan 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis

All Psoriasis trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Omentin-1 Level in Psoriatic Patients Treated With Narrowband Ultraviolet B Phototherapy Versus Acitretin
ClinicalTrials.gov ID: NCT05203354
Acronym / sponsor ID: 288/9/18
Conditions: Psoriasis
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Mahmoud Ahmed Ali AhmedUniversity, hospital or other
Study start: 1 Sep 2018 (actual)
Primary completion: 1 May 2021 (actual)
Study completion: 15 Aug 2021 (actual)
First posted: 24 Jan 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.

Studying the effects of Narrowband Ultraviolet B versus acitretin on psoriatic patients

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
NB-UVB group	Active comparator	Radiation: Narrowband Ultraviolet BPatients who receive Narrowband ultraviolet B phototherapy
Acitretin group	Active comparator	Drug: AcitretinPatients who receive acitretin
Control group	No intervention	–It includes apparently healthy people who will be compared to patients in the measurement of Omentin-1 level

Who may qualify

Ages: 20 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Patients of both sexes with psoriasis vulgaris.

Key exclusion criteria (3 listed)

• Patients with history of malignancies, renal and liver 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
Narrowband Ultraviolet BAlso: NB-UVB phototherapypatients will exposed to sessions of NB-UVB phototherapy twice weekly for 3 months	Radiation	NB-UVB group
Acitretinpatients will received acitretin in dose 0.5-1 mg/kg daily for 3 months	Drug	Acitretin group

Primary outcome

Decrease Omentin-1 serum level in both groups treated with NB-UVB and Acitretin
Time frame: 3 months
This outcome indicates potential role of Omentin-1 in psoriasis pathogenesis and its involvement in pathogenesis of obesity and related diseases as metabolic syndrome. So it will be concluded that high levels of this protein could be marker against obesity and related disorders including psoriasis. Omentin-1 can be valuable marker for psoriasis severity detected by its correlation with psoriasis area severity index (PASI) score and for evaluating the therapeutic outcomes

1 secondary outcome

Decrease PASI score in psoriatic patients
Time frame: 3 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2022.

Related trials for Psoriasis

Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Narrowband Ultraviolet B and Acitretin in people with Psoriasis, run by Mahmoud Ahmed Ali Ahmed 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 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: finished, as of the sponsor's last update on 24 Jan 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Decrease Omentin-1 serum level in both groups treated with NB-UVB and Acitretin (time frame: 3 months). 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 NCT05203354.

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 24 Jan 2022.