Plexin B2 Gene Expression and Polymorphisms in Psoriasis

South Valley University

Status and phase: Completed; Phase 1

Conditions: Psoriasis Vulgaris

Treatments: Radiation: Narrow band Ultraviolet B phototherapy group; Combination Product: Acitretin plus Narrow band Ultraviolet B phototherapy group; Drug: Acitretin group

Study type: Interventional

Funder types: Other

Identifiers

NCT05184348

Ebtehal Mohamed

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 24 to 64 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 4 patient groups

Narrow band Ultraviolet B phototherapy group

Active Comparator group

Description:

Patients will be treated with Narrow band Ultraviolet B phototherapy 3 sessions weekly for 3 months with maximum dose of 1400 mJ/cm2.

Treatment:

Radiation: Narrow band Ultraviolet B phototherapy group

Acitretin group

Active Comparator group

Description:

Patients will be treated with Acitretin in dose of 0.5-1 mg per kg per day orally for 3 months

Treatment:

Drug: Acitretin group

Acitretin plus Narrow band Ultraviolet B phototherapy group

Active Comparator group

Description:

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.

Treatment:

Combination Product: Acitretin plus Narrow band Ultraviolet B phototherapy group

Control group

No Intervention group

Description:

30 healthy individuals un related , age, sex , BMI matched with volunteers.