Back to resultsOmentin-1 Level in Psoriatic Patients Treated With Narrowband Ultraviolet B Phototherapy Versus Acitretin
Primary Purpose
Psoriasis
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Narrowband Ultraviolet B
Acitretin
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis
Eligibility Criteria
Inclusion Criteria:
- Patients of both sexes with psoriasis vulgaris.
Exclusion Criteria:
• Patients with history of malignancies, renal and liver diseases.
- Patients received NB-UVB phototherapy in the last 6 months.
- Patients treated with methotrexate or biologic agents and any systemic treatment of psoriasis.
Sites / Locations
- Faculty of medicine - Aswan university
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
No Intervention
Arm Label
NB-UVB group
Acitretin group
Control group
Arm Description
Patients who receive Narrowband ultraviolet B phototherapy
Patients who receive acitretin
It includes apparently healthy people who will be compared to patients in the measurement of Omentin-1 level
Outcomes
Primary Outcome Measures
Decrease Omentin-1 serum level in both groups treated with NB-UVB and Acitretin
This outcome indicates potential role of Omentin-1 in psoriasis pathogenesis and its involvement in pathogenesis of obesity and related diseases as metabolic syndrome. So it will be concluded that high levels of this protein could be marker against obesity and related disorders including psoriasis. Omentin-1 can be valuable marker for psoriasis severity detected by its correlation with psoriasis area severity index (PASI) score and for evaluating the therapeutic outcomes
Secondary Outcome Measures
Decrease PASI score in psoriatic patients
Decrease in PASI score in psoriatic patients after treatment with NB-UVB acitretin
Full Information
NCT ID
NCT05203354
First Posted
December 14, 2021
Last Updated
January 5, 2022
Sponsor
Mahmoud Ahmed Ali Ahmed
1. Study Identification
Unique Protocol Identification Number
NCT05203354
Brief Title
Omentin-1 Level in Psoriatic Patients Treated With Narrowband Ultraviolet B Phototherapy Versus Acitretin
Official Title
Omentin-1 Level in Psoriatic Patients Treated With Narrowband Ultraviolet B Phototherapy Versus Acitretin
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
May 1, 2021 (Actual)
Study Completion Date
August 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mahmoud Ahmed Ali Ahmed
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Studying the effects of Narrowband Ultraviolet B versus acitretin on psoriatic patients
Detailed Description
Compare the effects of Narrowband Ultraviolet B versus acitretin on serum Omentin-1 level in psoriatic patients as case control study by dividing patients into 3 groups: group 1 include patients receive Narrowband Ultraviolet B, group II includes patients receive acitretin (0.5-1 mg/day) and control group. The duration of this study about 3 months after receving those interventions.
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
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NB-UVB group
Arm Type
Active Comparator
Arm Description
Patients who receive Narrowband ultraviolet B phototherapy
Arm Title
Acitretin group
Arm Type
Active Comparator
Arm Description
Patients who receive acitretin
Arm Title
Control group
Arm Type
No Intervention
Arm Description
It includes apparently healthy people who will be compared to patients in the measurement of Omentin-1 level
Intervention Type
Radiation
Intervention Name(s)
Narrowband Ultraviolet B
Other Intervention Name(s)
NB-UVB phototherapy
Intervention Description
patients will exposed to sessions of NB-UVB phototherapy twice weekly for 3 months
Intervention Type
Drug
Intervention Name(s)
Acitretin
Intervention Description
patients will received acitretin in dose 0.5-1 mg/kg daily for 3 months
Primary Outcome Measure Information:
Title
Decrease Omentin-1 serum level in both groups treated with NB-UVB and Acitretin
Description
This outcome indicates potential role of Omentin-1 in psoriasis pathogenesis and its involvement in pathogenesis of obesity and related diseases as metabolic syndrome. So it will be concluded that high levels of this protein could be marker against obesity and related disorders including psoriasis. Omentin-1 can be valuable marker for psoriasis severity detected by its correlation with psoriasis area severity index (PASI) score and for evaluating the therapeutic outcomes
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Decrease PASI score in psoriatic patients
Description
Decrease in PASI score in psoriatic patients after treatment with NB-UVB acitretin
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients of both sexes with psoriasis vulgaris.
Exclusion Criteria:
• Patients with history of malignancies, renal and liver diseases.
Patients received NB-UVB phototherapy in the last 6 months.
Patients treated with methotrexate or biologic agents and any systemic treatment of psoriasis.
Facility Information:
Facility Name
Faculty of medicine - Aswan university
City
Aswan
ZIP/Postal Code
81528
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Omentin-1 Level in Psoriatic Patients Treated With Narrowband Ultraviolet B Phototherapy Versus Acitretin
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