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

Sponsor
Aswan University Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04811911
Collaborator
(none)
30
Enrollment
1
Location
3
Arms
12.1
Anticipated Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Evaluation of the Effect of Narrowband Ultraviolet B Versus Methotrexate on Serum TWEAK Level in Psoriasis
Actual Study Start Date :
Dec 13, 2020
Anticipated Primary Completion Date :
Sep 15, 2021
Anticipated Study Completion Date :
Dec 15, 2021

Arms and Interventions

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

    		•
    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

    		•
    No Intervention: healthy individuals as control group

    Outcome Measures

    Primary Outcome Measures

    1. Serum TWEAK in psoriasis [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).

    Secondary Outcome Measures

    1. Treatment of psoriasis [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Aswan University - Faculty of Medicine Aswan Aswan Governorate Egypt 81528

    Sponsors and Collaborators

    • Aswan University Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    El Hassan Mohsen Mansour Mahmoud, Principal investigator, Aswan University Hospital
    ClinicalTrials.gov Identifier:
    NCT04811911
    Other Study ID Numbers:
    • 498/12/20
    First Posted:
    Mar 23, 2021
    Last Update Posted:
    Mar 23, 2021
    Last Verified:
    Mar 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Psoriasis
    Methotrexate

    Study Results

    No Results Posted as of Mar 23, 2021