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Plexin B2 Gene Expression and Polymorphisms in Psoriasis

Primary Purpose

Psoriasis Vulgaris

Status
Completed
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Narrow band Ultraviolet B phototherapy group
Acitretin group
Acitretin plus Narrow band Ultraviolet B phototherapy group
Sponsored by
South Valley University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis Vulgaris

Eligibility Criteria

24 Years - 64 Years (Adult)All SexesAccepts 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.

Sites / Locations

  • Faculty of Medicine , South Valley University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

No Intervention

Arm Label

Narrow band Ultraviolet B phototherapy group

Acitretin group

Acitretin plus Narrow band Ultraviolet B phototherapy group

Control group

Arm Description

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

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

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 23, 2021
Last Updated
September 19, 2023
Sponsor
South Valley University
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1. Study Identification

Unique Protocol Identification Number
NCT05184348
Brief Title
Plexin B2 Gene Expression and Polymorphisms in Psoriasis
Official Title
Plexin B2 Gene Expression and Polymorphisms in Psoriasis : Relation to NB-UVB, Acitretin and Combined Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
January 30, 2023 (Actual)
Study Completion Date
March 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
South Valley University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis Vulgaris

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Narrow band Ultraviolet B phototherapy group
Arm Type
Active Comparator
Arm Description
Patients will be treated with Narrow band Ultraviolet B phototherapy 3 sessions weekly for 3 months with maximum dose of 1400 mJ/cm2.
Arm Title
Acitretin group
Arm Type
Active Comparator
Arm Description
Patients will be treated with Acitretin in dose of 0.5-1 mg per kg per day orally for 3 months
Arm Title
Acitretin plus Narrow band Ultraviolet B phototherapy group
Arm Type
Active Comparator
Arm 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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
30 healthy individuals un related , age, sex , BMI matched with volunteers.
Intervention Type
Radiation
Intervention Name(s)
Narrow band Ultraviolet B phototherapy group
Other Intervention Name(s)
NB-UVB
Intervention Description
3 sessions weekly for 3 months with maximum dose 1400 mJ/cm2.
Intervention Type
Drug
Intervention Name(s)
Acitretin group
Intervention Description
dose of 0.5-1 mg per kg per day orally for 3 month.
Intervention Type
Combination Product
Intervention Name(s)
Acitretin plus Narrow band Ultraviolet B phototherapy group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Improve the prognosis of patients with psoriasis Vulgaris
Description
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 Outcome Measure Information:
Title
Improve the clinical out comes of patients with psoriasis Vulgaris
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
24 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eisa Hegazy, Prof.
Organizational Affiliation
Faculty of Medicine, South Valley University, Egypt
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty of Medicine , South Valley University
City
Qina
Country
Egypt

12. IPD Sharing Statement

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Plexin B2 Gene Expression and Polymorphisms in Psoriasis

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