Evaluation The Effect of NB-UVB and Methotrexate on The Level of Serum Gelsolin in Psoriatic Patients
1 other identifier
interventional
48
1 country
1
Brief Summary
Psoriasis is a common chronic, immune-mediated, skin disease with a significantly negative impact on patients' quality of life. It is one of papulosquamous diseases defined by erythematous plaques with silvery scales. The interplay among cytokines released by dendritic, Th1, Th2, and Th17 cells leads to the clinical manifestations seen in psoriasis. Although discovering novel biomarkers for psoriasis is challenging step., it may play an essential role in diagnosis, severity assessment and prediction of treatment outcome and prognosis of the disease
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2024
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
June 10, 2024
CompletedFirst Submitted
Initial submission to the registry
November 20, 2024
CompletedFirst Posted
Study publicly available on registry
December 2, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 10, 2025
CompletedDecember 2, 2024
June 1, 2024
12 months
November 20, 2024
November 26, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Treatment of the Psoriasis
About 36 patients suffering from Psoriasis and will be treated by exposing to Narrow band ultraviolet B radiation (initial dose of 130 - 400 mJ / cm2 selected according to skin phototype and gradual increase after each session ), and taking Methotrexate tablets in dose of (0.3 mg/kg/week) along with folic acid (5 mg/day) .
3 months
Serum Gelsolin Evaluation
Evaluation the Serum Gelsolin level in Psoriatic Patients after treatment by Narrow band ultraviolet B and taking Methotrexate tablets.
3 Months
Study Arms (4)
Group A: (Narrow Band Ultraviolet B)
ACTIVE COMPARATORAbout 12 patients will expose to 24 sessions of Narrow Band Ultraviolet B (NB-UVB) radiation (initial dose of 130 - 400 mJ / cm2 ) selected according to skin for 3 month.
Group B: (Methotrexate )
ACTIVE COMPARATORAbout 12 patients will receive Methotrexate tablets (MTX) in dose of (0.3 mg/kg/week) along with folic acid (5 mg/day) for 3 month.
Group C: (Methotrexate and Narrow Band Ultraviolet B)
ACTIVE COMPARATORAbout 12 patients will undergo the treatment by both Methotrexate tablets (MTX) and Narrow Band Ultraviolet B( NB-UVB) radiation.for 3 month.
Group D (Control Group)
ACTIVE COMPARATORAbout 12 patients apparently healthy individuals as control group.and will not take any medication
Interventions
Comparison between serum Level of Gelsolin (GSN) in Psoriatic Patients and controls and correlate its level with PASI.
Eligibility Criteria
You may qualify if:
- Patients with moderate to severe plaque psoriasis.
- No restriction of age, race nor occupation.
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 diseases, chronic renal failure or cancer.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aswan Universitylead
Study Sites (1)
Aswan University Hospital
Aswān, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Moustafa Adam Ali El Taieb, Professor
Dermatology, Venereology and Andrology.Faculty of Medicine, Aswan University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Resident of Dermatology, Venereology and Andrology
Study Record Dates
First Submitted
November 20, 2024
First Posted
December 2, 2024
Study Start
June 10, 2024
Primary Completion
June 1, 2025
Study Completion
June 10, 2025
Last Updated
December 2, 2024
Record last verified: 2024-06