Plexin B2 Gene Expression and Polymorphisms in Psoriasis : Relation to Narrow Band Ultraviolet B , Acitretin and Combined Therapy
Study Details
Study Description
Brief Summary
Patients will be randomly assigned (1:1:1 ) either to ; NB-UVB photo-therapy alone , Acitretin therapy alone or NB-UVB photo-therapy combined with Acitretin therapy randomization will be done by closed envelopes . investigator will be blinded to study drug assignment , while patients and data interpreter will not be masked to study drug assignment.
Condition or Disease | Intervention/Treatment | Phase |
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|
Phase 4 |
Detailed Description
Study Setting: Qena University Hospital, Department of Dermatology ,Venereology& Andrology.
Study subjects: the study will include psoriasis Vulgaris patients who Come to the out patients dermatologic clinic and matching inclusion & exclusion criteria as follow, from 9/2021 up to 3/2023 and then patients will be divided to each group equally as follow:
Group 1: Patients will be treated with NB-UVB phototherapy 3 sessions weekly for 3 months with maximum dose of 1400 mJ/cm2.
Group 2: Patients will be treated with Acitretin in dose of 0.5-1 mg per kg per day orally for 3 months Group 3: Patients will be treated with Acitretin in dose of 0.5-1 mg per kg per day orally plus NB-UVB phototherapy 3 sessions weekly for 3 months with maximum dose 1400 mJ/cm2.
Group 4: 30 healthy individuals un related , age, sex , BMI matched with volunteers.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Narrow band Ultraviolet B phototherapy group Patients will be treated with Narrow band Ultraviolet B phototherapy 3 sessions weekly for 3 months with maximum dose of 1400 mJ/cm2. |
Radiation: Narrow band Ultraviolet B phototherapy group
3 sessions weekly for 3 months with maximum dose 1400 mJ/cm2.
Other Names:
|
Active Comparator: Acitretin group Patients will be treated with Acitretin in dose of 0.5-1 mg per kg per day orally for 3 months |
Drug: Acitretin group
dose of 0.5-1 mg per kg per day orally for 3 month.
|
Active Comparator: Acitretin plus Narrow band Ultraviolet B phototherapy group Patients will be treated with Acitretin in dose of 0.5-1 mg per kg per day orally plus NB-UVB phototherapy 3 sessions weekly for 3 months with maximum dose 1400 mJ/cm2. |
Combination Product: Acitretin plus Narrow band Ultraviolet B phototherapy group
Acitretin in dose of 0.5-1 mg per kg per day orally plus Narrow band Ultraviolet B phototherapy 3 sessions weekly for 3 months with maximum dose 1400 mJ/cm2.
|
No Intervention: Control group 30 healthy individuals un related , age, sex , BMI matched with volunteers. |
Outcome Measures
Primary Outcome Measures
- Improve the prognosis of patients with psoriasis Vulgaris [3 month]
detect the effect of Acitretin alone and Narrow band Ultraviolet B phototherapy alone versus combined therapy on genetic mutation and level of plexin b2 in patients with psoriasis Vulgaris
Secondary Outcome Measures
- Improve the clinical out comes of patients with psoriasis Vulgaris [12 month]
detect the effect of Acitretin alone and Narrow band Ultraviolet B phototherapy alone versus combined therapy on clinical out comes and PASI score of patients with psoriasis Vulgaris
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients of both sexes. Diagnosed clinically with moderate to severe Psoriasis Vulgaris.
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patients able to swallow tablet and receive Narrow band Ultraviolet B phototherapy without any contraindication
Exclusion Criteria:
Pregnancy , lactation & women intent to become pregnant within 3 year after discontinuation of acitretin Patients with Hyperlipidemia Patients with mental problems and depression Patients with a history of malignancies, renal & liver diseases. Patients with a history of any inflammatory diseases as atopic dermatitis , asthma ulcerative colitis ) and Crohn's disease Patients received NB-UVB phototherapy in the last 6 months. Patients treated with methotrexate or biologic agents and any systemic treatment of psoriasis.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Faculty of Medicine , South Valley University | Qina | Egypt |
Sponsors and Collaborators
- South Valley University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 226/8/21