Back to resultsEffect of Acitretin Versus Narrowband Ultraviolet B on Neopterin Level in Psoriatic Patients .
Primary Purpose
Psoriasis
Status
Active
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Acitretin 25Mg Cap
Narrowband ultraviolet B
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis
Eligibility Criteria
Inclusion Criteria:
- Patients with psoriasis diagnosed clinically Aged (15-60).
Exclusion Criteria:
- Patient with history of skin cancer.
- Patient with history of photosensitivity.
- Pregnancy and lactation.
- Liver failure.
- Renal failure.
- Patient with psoriatic artheritis.
- Patient with allergy to product or any of its components.
- Patient with poorly controlled dyslipidemia.
- Patient receiving tetracyclines.
Sites / Locations
- South Valley University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Acitretin
Narrowband ultraviolet B
Combination of Narrowband ultraviolet B and Acitretin
Arm Description
Patients will Receive Acitretin (0.25-1 mg /kg/day )for 3months .
Patients will receive Narrowband UVB( 3session /week ) for 3months.
Patients will receive Acitretin (0.25-1 mg /kg/day ) and Narrowband UVB( 3session /week ) for 3 months.
Outcomes
Primary Outcome Measures
Serum Neopterin in psoriasis
Measurement of Neopterin in psoriatic patients before and after treatment with NB-UVB, Acitretin and combination of both modalities 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, Acitretin and combination of both modalities.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05401006
Brief Title
Effect of Acitretin Versus Narrowband Ultraviolet B on Neopterin Level in Psoriatic Patients .
Official Title
Evaluation of the Effect of Acitretin Versus Narrowband Ultraviolet B on Serum Neopterin Level in Psoriatic Patients .
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 5, 2021 (Actual)
Primary Completion Date
June 5, 2022 (Anticipated)
Study Completion Date
June 5, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
South Valley University
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
To evaluate effect of acitretin versus Narrowband UVB on serum level of neopterin 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
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Acitretin
Arm Type
Active Comparator
Arm Description
Patients will Receive Acitretin (0.25-1 mg /kg/day )for 3months .
Arm Title
Narrowband ultraviolet B
Arm Type
Active Comparator
Arm Description
Patients will receive Narrowband UVB( 3session /week ) for 3months.
Arm Title
Combination of Narrowband ultraviolet B and Acitretin
Arm Type
Active Comparator
Arm Description
Patients will receive Acitretin (0.25-1 mg /kg/day ) and Narrowband UVB( 3session /week ) for 3 months.
Intervention Type
Drug
Intervention Name(s)
Acitretin 25Mg Cap
Intervention Description
Acitretin is an oral retinoid (a derivative of vitamin A) given in a dose 0.25-1 mg /kg/day for 3months in psoriatic patients
Intervention Type
Radiation
Intervention Name(s)
Narrowband ultraviolet B
Other Intervention Name(s)
Narrowband UVB
Intervention Description
Narrowband UVB is the most common form of phototherapy used to treat psoriasis, given 2-3 sessions per week for 3 successive months
Primary Outcome Measure Information:
Title
Serum Neopterin in psoriasis
Description
Measurement of Neopterin in psoriatic patients before and after treatment with NB-UVB, Acitretin and combination of both modalities 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, Acitretin and combination of both modalities.
Time Frame
3 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with psoriasis diagnosed clinically Aged (15-60).
Exclusion Criteria:
Patient with history of skin cancer.
Patient with history of photosensitivity.
Pregnancy and lactation.
Liver failure.
Renal failure.
Patient with psoriatic artheritis.
Patient with allergy to product or any of its components.
Patient with poorly controlled dyslipidemia.
Patient receiving tetracyclines.
Facility Information:
Facility Name
South Valley University
City
Qinā
Country
Egypt
12. IPD Sharing Statement
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Effect of Acitretin Versus Narrowband Ultraviolet B on Neopterin Level in Psoriatic Patients .
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