Plexin B2 Gene Expression and Polymorphisms in Psoriasis

Phase 1

Completed

• Conditions: Psoriasis Vulgaris
• Interventions: Drug: Acitretin group; Radiation: Narrow band Ultraviolet B phototherapy group; Combination Product: Acitretin plus Narrow band Ultraviolet B phototherapy group

• Registration Number: NCT05184348
• Lead Sponsor: South Valley University

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.

Study Timeline

• Study Start: 2021-09-01
• Study First Submitted: 2021-11-23
• Study First Submitted QC: 2022-01-07
• Study First Posted: 2022-01-11
• Primary Completion: 2023-01-30
• Study Completion: 2023-03-30
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-19
• Last Update Posted: 2023-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acitretin group	Acitretin group	Patients will be treated with Acitretin in dose of 0.5-1 mg per kg per day orally for 3 months
Narrow band Ultraviolet B phototherapy group	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.
Acitretin plus Narrow band Ultraviolet B phototherapy group	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Faculty of Medicine , South Valley University; 🇪🇬 Qina, Egypt