Back to resultsEvaluation of the Effect of Narrowband UVB Versus Methotrexate on Serum TWEAK Level in Psoriasis
Primary Purpose
Psoriasis
Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Narrowband ultraviolet B
Methotrexate
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis
Eligibility Criteria
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
Sites / Locations
- Aswan University - Faculty of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
No Intervention
Arm Label
Narrowband ultraviolet B
Methotrexate group
healthy individuals as control group
Arm Description
Patients will receive 8 sessions of NB-UVB per month for 3 successive months
Patients will receive 25 mg/1ml of methotrexate vial per week for 3 successive months
Outcomes
Primary Outcome Measures
Serum TWEAK in psoriasis
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
Treatment of psoriasis
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.
Full Information
NCT ID
NCT04811911
First Posted
March 5, 2021
Last Updated
March 20, 2021
Sponsor
Aswan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04811911
Brief Title
Evaluation of the Effect of Narrowband UVB Versus Methotrexate on Serum TWEAK Level in Psoriasis
Official Title
Evaluation of the Effect of Narrowband Ultraviolet B Versus Methotrexate on Serum TWEAK Level in Psoriasis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 13, 2020 (Actual)
Primary Completion Date
September 15, 2021 (Anticipated)
Study Completion Date
December 15, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aswan University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Narrowband ultraviolet B
Arm Type
Active Comparator
Arm Description
Patients will receive 8 sessions of NB-UVB per month for 3 successive months
Arm Title
Methotrexate group
Arm Type
Active Comparator
Arm Description
Patients will receive 25 mg/1ml of methotrexate vial per week for 3 successive months
Arm Title
healthy individuals as control group
Arm Type
No Intervention
Intervention Type
Radiation
Intervention Name(s)
Narrowband ultraviolet B
Other Intervention Name(s)
NB-UVB
Intervention Description
Patients will receive 8 sessions of NB-UVB per month for 3 successive months
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Other Intervention Name(s)
MTX
Intervention Description
Patients will receive 25 mg/1ml of methotrexate vial per week for 3 successive months
Primary Outcome Measure Information:
Title
Serum TWEAK in psoriasis
Description
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).
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Treatment of psoriasis
Description
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.
Time Frame
3 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moustafa A El Taieb, Professor
Organizational Affiliation
Faculty of medicine aswan university
Official's Role
Study Chair
Facility Information:
Facility Name
Aswan University - Faculty of Medicine
City
Aswan
State/Province
Aswan Governorate
ZIP/Postal Code
81528
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Effect of Narrowband UVB Versus Methotrexate on Serum TWEAK Level in Psoriasis
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