Evaluation of the Effect of Narrowband UVB Versus Methotrexate on Serum TWEAK Level in Psoriasis

March 20, 2021 updated by: El Hassan Mohsen Mansour Mahmoud, Aswan University Hospital

Evaluation of the Effect of Narrowband Ultraviolet B Versus Methotrexate on Serum TWEAK Level in Psoriasis

The aim of the study is to evaluate the effect of NB-UVB versus MTX on serum TWEAK level in psoriatic patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

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 Governorate
      • Aswan, Aswan Governorate, Egypt, 81528
        • Aswan University - Faculty of Medicine

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with moderate to severe plaque psoriasis of any age and gender.

Exclusion Criteria:

  • History of psoriasis treatment with systemic and biological agents prior to the study for at least 3 months.
  • Pregnancy and lactation.
  • Infections
  • Patients with chronic diseases: hepatic disorders, hematologic disease, chronic renal failure or cancer

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: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Narrowband ultraviolet B
Patients will receive 8 sessions of NB-UVB per month for 3 successive months
Radiation: Narrowband ultraviolet B
Patients will receive 8 sessions of NB-UVB per month for 3 successive months
Other Names:
  • NB-UVB
No Intervention: healthy individuals as control group
Active Comparator: Methotrexate group
Patients will receive 25 mg/1ml of methotrexate vial per week for 3 successive months
Drug: Methotrexate
Patients will receive 25 mg/1ml of methotrexate vial per week for 3 successive months
Other Names:
  • MTX

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum TWEAK in psoriasis
Time Frame: 3 months
Measurement of tumor necrosis factor weak inducer of apoptosis (TWEAK) "pg/ml"; in psoriatic patients before and after treatment with NB-UVB versus MTX in comparison with healthy individuals, using ELISA (enzyme-linked immunosorbent assay).
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment of psoriasis
Time Frame: 3 months
Clinical evaluation: Assessment of disease severity will be performed by using psoriasis area severity index (PASI score) before and after treatment with NB-UVB in comparison with MTX. Patients will be photographed at baseline and after 3 months of regular treatment by using high resolution digital camera canon EOS 1300D 18 megapixels (made in taiwan), photography will be done in standard light and distance.
3 months

Collaborators and Investigators

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

Sponsor

Aswan University Hospital

Investigators

  • Study Chair: Moustafa A El Taieb, Professor, Faculty of medicine aswan university

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)

December 13, 2020

Primary Completion (Anticipated)

September 15, 2021

Study Completion (Anticipated)

December 15, 2021

Study Registration Dates

First Submitted

March 5, 2021

First Submitted That Met QC Criteria

March 20, 2021

First Posted (Actual)

March 23, 2021

Study Record Updates

Last Update Posted (Actual)

March 23, 2021

Last Update Submitted That Met QC Criteria

March 20, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 498/12/20

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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