Plexin B2 Gene Expression and Polymorphisms in Psoriasis

NCT ID: NCT05184348

Last Updated: 2023-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2023-03-30

Brief Summary

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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

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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

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Psoriasis Vulgaris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Narrow band Ultraviolet B phototherapy group

Intervention Type RADIATION

3 sessions weekly for 3 months with maximum dose 1400 mJ/cm2.

Acitretin group

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

Group Type ACTIVE_COMPARATOR

Acitretin group

Intervention Type DRUG

dose of 0.5-1 mg per kg per day orally for 3 month.

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.

Group Type ACTIVE_COMPARATOR

Acitretin plus Narrow band Ultraviolet B phototherapy group

Intervention Type COMBINATION_PRODUCT

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.

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Narrow band Ultraviolet B phototherapy group

3 sessions weekly for 3 months with maximum dose 1400 mJ/cm2.

Intervention Type RADIATION

Acitretin group

dose of 0.5-1 mg per kg per day orally for 3 month.

Intervention Type DRUG

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.

Intervention Type COMBINATION_PRODUCT

Other Intervention Names

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NB-UVB

Eligibility Criteria

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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.
Minimum Eligible Age

24 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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South Valley University

OTHER

Sponsor Role lead

Responsible Party

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Ebtehal alaa el Dean kotop Mohamed, MD

Assitant lecturer of Dermatology, Venereology & Andrology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eisa Hegazy, Prof.

Role: STUDY_CHAIR

Faculty of Medicine, South Valley University, Egypt

Locations

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Faculty of Medicine , South Valley University

Qina, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Ebtehal Mohamed

Identifier Type: -

Identifier Source: org_study_id

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