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Thymic Stromal Lymphopoietin (TSLP) in Vitiligo

Primary Purpose

Vitiligo

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
skin biopsy
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Vitiligo

Eligibility Criteria

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

Inclusion Criteria:

  • • Patients with generalized non-segmental vitiligo.

    • Both sexes.
    • Age < 18 years old age.
    • New cases or cases not receiving any medication for at least 3 months ago.

Exclusion Criteria:

  • • Age: Patients < 18 years.

    • Segmental or universal vitiligo.
    • Pregnant and lactating females. Autoimmune diseases

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    vitiligo patients

    controls

    Arm Description

    Outcomes

    Primary Outcome Measures

    Expression levels of TSLP in patients of Vitiligo.

    Secondary Outcome Measures

    Full Information

    First Posted
    December 5, 2017
    Last Updated
    December 18, 2017
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03367273
    Brief Title
    Thymic Stromal Lymphopoietin (TSLP) in Vitiligo
    Official Title
    Study of the Cutaneous Expression of Thymic Stromal Lymphopoietin (TSLP) in a Sample of Vitiligo Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2017 (Actual)
    Primary Completion Date
    July 2017 (Actual)
    Study Completion Date
    July 2017 (Actual)

    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
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    study & verify the hypothesis of the involvement of TSLP in the pathogenesis of vitiligo in comparison to their levels in the healthy control persons.

    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
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    vitiligo patients
    Arm Type
    Experimental
    Arm Title
    controls
    Arm Type
    Experimental
    Intervention Type
    Other
    Intervention Name(s)
    skin biopsy
    Intervention Description
    Lesional skin biopsy was taken from every patient. Also a skin biopsy was taken from every control subject
    Primary Outcome Measure Information:
    Title
    Expression levels of TSLP in patients of Vitiligo.
    Time Frame
    7 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: • Patients with generalized non-segmental vitiligo. Both sexes. Age < 18 years old age. New cases or cases not receiving any medication for at least 3 months ago. Exclusion Criteria: • Age: Patients < 18 years. Segmental or universal vitiligo. Pregnant and lactating females. Autoimmune diseases

    12. IPD Sharing Statement

    Learn more about this trial

    Thymic Stromal Lymphopoietin (TSLP) in Vitiligo

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