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

January 5, 2022 updated by: Mahmoud Ahmed Ali Ahmed
Studying the effects of Narrowband Ultraviolet B versus acitretin on psoriatic patients

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Aswan, Egypt, 81528
        • Faculty of medicine - Aswan university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients of both sexes with psoriasis vulgaris.

Exclusion Criteria:

  • • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: NB-UVB group
Patients who receive Narrowband ultraviolet B phototherapy
Radiation: Narrowband Ultraviolet B
patients will exposed to sessions of NB-UVB phototherapy twice weekly for 3 months
Other Names:
  • NB-UVB phototherapy
Active Comparator: Acitretin group
Patients who receive acitretin
Drug: Acitretin
patients will received acitretin in dose 0.5-1 mg/kg daily for 3 months
No Intervention: Control group
It includes apparently healthy people who will be compared to patients in the measurement of Omentin-1 level

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decrease PASI score in psoriatic patients
Time Frame: 3 months
Decrease in PASI score in psoriatic patients after treatment with NB-UVB acitretin
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahmoud Ahmed Ali Ahmed

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2018

Primary Completion (Actual)

May 1, 2021

Study Completion (Actual)

August 15, 2021

Study Registration Dates

First Submitted

December 14, 2021

First Submitted That Met QC Criteria

January 5, 2022

First Posted (Actual)

January 24, 2022

Study Record Updates

Last Update Posted (Actual)

January 24, 2022

Last Update Submitted That Met QC Criteria

January 5, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 288/9/18

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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