NCT05184348

Plexin B2 Gene Expression and Polymorphisms in Psoriasis

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: South Valley University · Academic / Other
• Sex: All
• Age: 24 Years – 64 Years
• Healthy volunteers: Accepted

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.

Conditions

• Psoriasis Vulgaris

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-09-01
• Primary completion: 2023-01-30
• Completion: 2023-03-30
• First posted: 2022-01-11
• Last updated: 2023-09-21

Locations

1 site across 1 country: Egypt