Evaluation of the Effect of Narrowband UVB Versus Methotrexate on Serum TWEAK Level in Psoriasis
1 other identifier
interventional
30
1 country
1
Brief Summary
The aim of the study is to evaluate the effect of NB-UVB versus MTX on serum TWEAK level in psoriatic patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Dec 2020
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 13, 2020
CompletedFirst Submitted
Initial submission to the registry
March 5, 2021
CompletedFirst Posted
Study publicly available on registry
March 23, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2021
CompletedMarch 23, 2021
March 1, 2021
9 months
March 5, 2021
March 20, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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).
3 months
Secondary Outcomes (1)
Treatment of psoriasis
3 months
Study Arms (3)
Narrowband ultraviolet B
ACTIVE COMPARATORPatients will receive 8 sessions of NB-UVB per month for 3 successive months
Methotrexate group
ACTIVE COMPARATORPatients will receive 25 mg/1ml of methotrexate vial per week for 3 successive months
healthy individuals as control group
NO INTERVENTIONInterventions
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
Eligibility Criteria
You may qualify if:
- Patients with moderate to severe plaque psoriasis of any age and gender.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Aswan University - Faculty of Medicine
Aswān, Aswan Governorate, 81528, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Moustafa A El Taieb, Professor
Faculty of medicine aswan university
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
March 5, 2021
First Posted
March 23, 2021
Study Start
December 13, 2020
Primary Completion
September 15, 2021
Study Completion
December 15, 2021
Last Updated
March 23, 2021
Record last verified: 2021-03