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Human Beta-defensin 1 in Vitiligo

Primary Purpose

Vitiligo

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

About this trial

This is an interventional diagnostic trial for Vitiligo

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients with non-segmental vitiligo.
  • Both genders.
  • Age more than 18 years old.
  • New cases or cases not receiving any treatment for at least 3 months prior to the study.

Exclusion Criteria:

  • Universal or segmental vitiligo.
  • Any contraindication to phototherapy treatment.
  • History of autoimmune diseases or other systemic diseases.
  • Any other skin disease.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    vitiligo patients

    Healthy controls

    Arm Description

    Tissue levels of human beta-defensin 1 in vitiligo patients before and after NB-UVB phototherapy

    Tissue levels of human beta-defensin 1 in healthy controls

    Outcomes

    Primary Outcome Measures

    Tissue levels of human beta-defensin 1 before and after NB-UVB phototherapy

    Secondary Outcome Measures

    Full Information

    First Posted
    February 5, 2019
    Last Updated
    February 5, 2019
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03832751
    Brief Title
    Human Beta-defensin 1 in Vitiligo
    Official Title
    Estimation of Tissue Level of Human Beta-defensin 1 (HBD-1) in Vitiligo Before and After Narrowband UVB Phototherapy: a Case-control Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2019 (Anticipated)
    Primary Completion Date
    December 2019 (Anticipated)
    Study Completion Date
    December 2019 (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
    There is a need to know the role of human beta defensin-1 in vitiligo pathogenesis and the probability of finding newer and effective therapy for vitiligo in the future.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    25 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    vitiligo patients
    Arm Type
    Experimental
    Arm Description
    Tissue levels of human beta-defensin 1 in vitiligo patients before and after NB-UVB phototherapy
    Arm Title
    Healthy controls
    Arm Type
    Active Comparator
    Arm Description
    Tissue levels of human beta-defensin 1 in healthy controls
    Intervention Type
    Other
    Intervention Name(s)
    skin biopsy before and after NB-UVB phototherapy
    Intervention Description
    skin biopsy before and after NB-UVB phototherapy to measure tissue human beta-defensin 1
    Primary Outcome Measure Information:
    Title
    Tissue levels of human beta-defensin 1 before and after NB-UVB phototherapy
    Time Frame
    6 months to 1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients with non-segmental vitiligo. Both genders. Age more than 18 years old. New cases or cases not receiving any treatment for at least 3 months prior to the study. Exclusion Criteria: Universal or segmental vitiligo. Any contraindication to phototherapy treatment. History of autoimmune diseases or other systemic diseases. Any other skin disease.

    12. IPD Sharing Statement

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    Human Beta-defensin 1 in Vitiligo

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