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The Effect of NB-UVB on Interleukin-36 Levels in Psoriasis

Primary Purpose

Psoriasis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
NB-UVB
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Psoriasis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with psoriasis vulgaris of both sexes
  • Age between 18 and 60 years old.

Exclusion Criteria:

  • Pregnant females
  • Patients receiving systemic treatment or topical treatment for psoriasis within the past two months.
  • Patients having other dermatological diseases.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    nb-uvb

    Arm Description

    psoriasis patients will receive 26 sessions of nb-uvb phototherapy

    Outcomes

    Primary Outcome Measures

    changes in Il-36 levels in 25 psoriasis patients after 26 sessions of NB-UVB
    primary

    Secondary Outcome Measures

    changes in cathepsin G levels in 25 psoriasis patients after 26 sessions of NB-UVB psoriasis
    secondary

    Full Information

    First Posted
    May 4, 2018
    Last Updated
    July 20, 2019
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03526705
    Brief Title
    The Effect of NB-UVB on Interleukin-36 Levels in Psoriasis
    Official Title
    The Effect of NB-UVB on Interleukin-36 Levels in Psoriasis Lesional Skin
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 15, 2019 (Anticipated)
    Primary Completion Date
    January 15, 2020 (Anticipated)
    Study Completion Date
    January 15, 2020 (Anticipated)

    3. Sponsor/Collaborators

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

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Psoriasis is an immune-mediated skin disease that affects 1-2 % of the population. Several cytokines have been found to be involved in the complex pathogenesis of this disease. Il- 36 is one of the cytokines sharing in psoriasis pathogenesis, as its levels are elevated in psoriatic plaques. Cathepsin G is known to activate Il- 36 and promote inflammation in psoriasis.NB-UVB is one of the important treatment modalities for psoriasis. The aim of this study is to detect the effect of NB-UVB on the lesional levels of IL-36 in psoriasis.
    Detailed Description
    25 psoriasis patients will receive 26 sessions of phototherapy (NB-UVB). Patients will receive 3 sessions per week. Tissue levels of IL-36 and Cathepsin G will be assessed in skin lesions before starting treatment and after completing the 26 sessions.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    25 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    nb-uvb
    Arm Type
    Experimental
    Arm Description
    psoriasis patients will receive 26 sessions of nb-uvb phototherapy
    Intervention Type
    Device
    Intervention Name(s)
    NB-UVB
    Intervention Description
    Phototherapy
    Primary Outcome Measure Information:
    Title
    changes in Il-36 levels in 25 psoriasis patients after 26 sessions of NB-UVB
    Description
    primary
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    changes in cathepsin G levels in 25 psoriasis patients after 26 sessions of NB-UVB psoriasis
    Description
    secondary
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with psoriasis vulgaris of both sexes Age between 18 and 60 years old. Exclusion Criteria: Pregnant females Patients receiving systemic treatment or topical treatment for psoriasis within the past two months. Patients having other dermatological diseases.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    The Effect of NB-UVB on Interleukin-36 Levels in Psoriasis

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