Plexin B2 Gene Expression and Polymorphisms in Psoriasis

Study Overview
=================
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.

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.

Official Title
-----------------
Plexin B2 Gene Expression and Polymorphisms in Psoriasis : Relation to NB-UVB, Acitretin and Combined Therapy

Conditions
-----------------
Psoriasis Vulgaris

Intervention / Treatment
-----------------
* Radiation: Narrow band Ultraviolet B phototherapy group
* Drug: Acitretin group
* Combination Product: Acitretin plus Narrow band Ultraviolet B phototherapy group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of both sexes. Diagnosed clinically with moderate to severe Psoriasis Vulgaris. 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.

Ages Eligible for Study
-----------------
Minimum Age: 24 Years
Maximum Age: 64 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Narrow band Ultraviolet B phototherapy group<br>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<br>* 3 sessions weekly for 3 months with maximum dose 1400 mJ/cm2.<br>* Other names: NB-UVB;|
| Active Comparator: Acitretin group<br>Patients will be treated with Acitretin in dose of 0.5-1 mg per kg per day orally for 3 months | Drug: Acitretin group<br>* dose of 0.5-1 mg per kg per day orally for 3 month.<br>|
| Active Comparator: Acitretin plus Narrow band Ultraviolet B phototherapy group<br>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<br>* 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.<br>|
| No Intervention: Control group<br>30 healthy individuals un related , age, sex , BMI matched with volunteers. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improve the prognosis of patients with psoriasis Vulgaris | 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 | 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improve the clinical out comes of patients with psoriasis Vulgaris | 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 | 12 month |