Plexin B2 Gene Expression and Polymorphisms in Psoriasis : Relation to Narrow Band Ultraviolet B , Acitretin and Combined Therapy

Sponsor
South Valley University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05184348
Collaborator
(none)
200
1
4
20.7
9.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: Narrow band Ultraviolet B phototherapy group
  • Drug: Acitretin group
  • Combination Product: Acitretin plus Narrow band Ultraviolet B phototherapy group
Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Treatment
Official Title:
Plexin B2 Gene Expression and Polymorphisms in Psoriasis : Relation to NB-UVB, Acitretin and Combined Therapy
Actual Study Start Date :
Nov 23, 2021
Anticipated Primary Completion Date :
Aug 15, 2022
Anticipated Study Completion Date :
Aug 15, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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.

Radiation: Narrow band Ultraviolet B phototherapy group
3 sessions weekly for 3 months with maximum dose 1400 mJ/cm2.
Other Names:
  • NB-UVB
  • Active Comparator: Acitretin group

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

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

    Active Comparator: 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.

    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.

    No Intervention: Control group

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

    Outcome Measures

    Primary Outcome Measures

    1. Improve the prognosis of patients with psoriasis Vulgaris [3 month]

      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

    1. Improve the clinical out comes of patients with psoriasis Vulgaris [12 month]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of Medicine , South Valley University Qina Egypt

    Sponsors and Collaborators

    • South Valley University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ebtehal alaa el Dean kotop Mohamed, MD, Assitant lecturer of Dermatology, Venereology & Andrology, South Valley University
    ClinicalTrials.gov Identifier:
    NCT05184348
    Other Study ID Numbers:
    • 226/8/21
    First Posted:
    Jan 11, 2022
    Last Update Posted:
    Feb 21, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 21, 2022