Plexin B2 Gene Expression and Polymorphisms in Psoriasis

South Valley University200 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

200

Conditions

Psoriasis Vulgaris

Interventions

Narrow band Ultraviolet B phototherapy groupRADIATION

3 sessions weekly for 3 months with maximum dose 1400 mJ/cm2.

Acitretin groupDRUG

dose of 0.5-1 mg per kg per day orally for 3 month.

Acitretin plus Narrow band Ultraviolet B phototherapy groupCOMBINATION_PRODUCT

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.

Eligibility

Sex: ALLMin age: 24 YearsMax age: 64 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Faculty of Medicine , South Valley University

Qina, Egypt

Outcomes

Primary Outcomes

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

Time frame: 3 month

Secondary Outcomes

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

Time frame: 12 month

Data from ClinicalTrials.gov

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