Plexin B2 Gene Expression and Polymorphisms in Psoriasis

Psoriasis Vulgaris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05184348
• Other study ID #: Ebtehal Mohamed
• Status: Completed
• Phase: Phase 1
• Start date: September 1, 2021
• Est. completion date: March 30, 2023

Study information

• Verified date: September 2023
• Source: South Valley University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 30, 2023
• Est. primary completion date: January 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 24 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis
• Psoriasis Vulgaris

Intervention

Radiation:
• Narrow band Ultraviolet B phototherapy group
3 sessions weekly for 3 months with maximum dose 1400 mJ/cm2.

Drug:
• Acitretin group
dose of 0.5-1 mg per kg per day orally for 3 month.

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.

Locations

Country	Name	City	State
Egypt	Faculty of Medicine , South Valley University	Qina

Sponsors (1)

Lead Sponsor	Collaborator
South Valley University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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