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Combined Oral Vitamin D and UVB Versus UVB Alone in Treatment of Psoriasis Vulgaris

Primary Purpose

Psoriasis Vulgaris

Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
oral vitamin D
Sponsored by
Assiut University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis Vulgaris

Eligibility Criteria

10 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • : patients from 10 to 60 diagnosed to have psoriasis vulgaris

Exclusion Criteria:

  1. concomitant chronic inflammatory disease or malignancy.
  2. pregnant and lactating women.
  3. renal dysfunction.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    measure serum vitamin D before and after treatment in psoriatic patients
    A 3ml blood sample will be collected from the patients, then allowed to clot for 10 minutes and then centrifuged . Group 1: 20 patients under oral vitamin D therapy ( oral alpha one for 3 months o.25 microgram / day ) in combination with narrow band UVB settings (twice/week) Group 2 : 20 patients under narrow band UVB therapy only . c) We evaluate psoriatic patient by PASI score before and after treatment : ) measurment vitamin D level before and after treatment.

    Secondary Outcome Measures

    We evaluate psoriatic patient by PASI score before and after treatment :
    The body is divided into four sections (head (H) (10% of a person's skin); arms (A) (20%); trunk (T) (30%); legs (L) (40%)). Each of these areas is scored by itself, and then the four scores are combined into the final PASI. For each section, the percent of area of skin involved, is estimated and then transformed into a grade from 0 to 6: 0.0% of involved area 1.< 10% of involved area 2.10-29% of involved area 3.30-49% of involved area 4.50-69% of involved area 5.70-89% of involved area 6.90-100% of involved area

    Full Information

    First Posted
    March 6, 2019
    Last Updated
    March 13, 2019
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03874975
    Brief Title
    Combined Oral Vitamin D and UVB Versus UVB Alone in Treatment of Psoriasis Vulgaris
    Official Title
    Combined Oral Vitamin D and UVB Versus Alone in Treatment of Psoroasis Vulgaris
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 1, 2019 (Anticipated)
    Primary Completion Date
    April 1, 2019 (Anticipated)
    Study Completion Date
    April 1, 2020 (Anticipated)

    3. Sponsor/Collaborators

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

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    Brief Summary
    To compare the results of vitamin D plus UVB in treatment of psoriasis vulgaris with the results of UVB alone to study the relation between serum vitamin D and PASI score before and after treatment.
    Detailed Description
    Psoriasis is a chronic immune-mediated inflammatory skin disease, with a prevalence of about 2%-3% in the general population. The primary manifestation of psoriasis most commonly manifests on the skin, although inflammatory processes can occur also in other organs . Vitamin D, also known as the sunshine vitamin, has long been known to be a hormone that regulates calcium-phosphorous homeostasis and safeguards the integrity of the skeletal system . The epidermis is the natural source of vitamin D synthesis by the action of ultraviolet light (UV) B of the sun or other UVB source . On the other hand, evidence is accumulating that vitamin D might represent a key modulator of immune and inflammation mechanisms . Recently, a role for vitamin D in the pathogenesis of different skin diseases, including psoriasis, has been reported. Psoriasis lesions are characterized by hyper-proliferation with incomplete differentiation of epidermal keratinocytes and decreased keratinocyte apoptosis, associated with inflammatory cellular infiltrate in both dermis and epidermis . Psoriasis Area and Severity Index (PASI) score is currently the preferred method for the assessment of the disease severity and extent . Physiologically, the active form of vitamin D and its receptor regulate the differentiation and proliferation of keratinocytes, the balance of the cutaneous immune system and the process of apoptosis. Several studies identified an association between polymorphisms of vitamin D receptor (VDR) and psoriasis susceptibility .The 1,25(OH)D has been shown to exert anti-proliferative effects on keratinocytes . The exact mechanism of action of NBUVB is not known. It is proposed that it acts in the following ways: (1) Cellular DNA is converted to pyrimidine dimers which interfere with cell cycle progression, (2) alteration in cytokine production, NBUVB phototherapy as the second-line treatment for psoriasis, recommended when the topical therapy fails, is contraindicated or impractical. UVB radia- tions of wavelength 311 nm may result in the clearance of disease symptoms after just 5-8 weeks.

    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
    Early Phase 1
    Interventional Study Model
    Single Group Assignment
    Model Description
    40 patients divided into two groups : group 1 :20 patients underoral vitamin D and UVB group 2 : 20 patients under uvb alone in psoriatic patients
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    oral vitamin D
    Other Intervention Name(s)
    narrow band UVB
    Intervention Description
    vitamin D and UVB versus UVB alone in psoriatic patients and evaluate patients by PASI score before and after treatment and measure serum vitamin D before and after treatment
    Primary Outcome Measure Information:
    Title
    measure serum vitamin D before and after treatment in psoriatic patients
    Description
    A 3ml blood sample will be collected from the patients, then allowed to clot for 10 minutes and then centrifuged . Group 1: 20 patients under oral vitamin D therapy ( oral alpha one for 3 months o.25 microgram / day ) in combination with narrow band UVB settings (twice/week) Group 2 : 20 patients under narrow band UVB therapy only . c) We evaluate psoriatic patient by PASI score before and after treatment : ) measurment vitamin D level before and after treatment.
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    We evaluate psoriatic patient by PASI score before and after treatment :
    Description
    The body is divided into four sections (head (H) (10% of a person's skin); arms (A) (20%); trunk (T) (30%); legs (L) (40%)). Each of these areas is scored by itself, and then the four scores are combined into the final PASI. For each section, the percent of area of skin involved, is estimated and then transformed into a grade from 0 to 6: 0.0% of involved area 1.< 10% of involved area 2.10-29% of involved area 3.30-49% of involved area 4.50-69% of involved area 5.70-89% of involved area 6.90-100% of involved area
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    10 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: : patients from 10 to 60 diagnosed to have psoriasis vulgaris Exclusion Criteria: concomitant chronic inflammatory disease or malignancy. pregnant and lactating women. renal dysfunction.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    meryhan abdelazeem, master
    Phone
    01204425625
    Email
    ashrafmeryhan7@gmail.com

    12. IPD Sharing Statement

    Learn more about this trial

    Combined Oral Vitamin D and UVB Versus UVB Alone in Treatment of Psoriasis Vulgaris

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