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The Analysis of Hair Count in Healthy Taiwanese Persons by Trichoscope

Primary Purpose

Dermatosis

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
photofinder levicam
Sponsored by
Shin Kong Wu Ho-Su Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Dermatosis

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 20-50y/o adults without any scalp disorder

Exclusion Criteria:

  • adults with any scalp disorder

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    men's hair count

    women's hair count

    Arm Description

    Outcomes

    Primary Outcome Measures

    Average number of hairs
    Exam frontal, bilateral Temporal and occipital scalp by photofinder levicam

    Secondary Outcome Measures

    Average hair shaft thickness
    Exam frontal, bilateral Temporal and occipital scalp by photofinder levicam
    Amount of Single, double and riple follicular unit
    Exam frontal, bilateral Temporal and occipital scalp by photofinder levicam
    Amount of Empty hair follicles
    Exam frontal, bilateral Temporal and occipital scalp by photofinder levicam

    Full Information

    First Posted
    April 29, 2019
    Last Updated
    December 30, 2019
    Sponsor
    Shin Kong Wu Ho-Su Memorial Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03937557
    Brief Title
    The Analysis of Hair Count in Healthy Taiwanese Persons by Trichoscope
    Official Title
    The Analysis of Hair Count in Healthy Taiwanese Persons by Trichoscope
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2019
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Insufficient funds
    Study Start Date
    May 5, 2019 (Anticipated)
    Primary Completion Date
    April 5, 2020 (Anticipated)
    Study Completion Date
    April 22, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shin Kong Wu Ho-Su Memorial Hospital

    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
    Horizontal sectioning of scalp biopsy is a better method for evaluating hair disorders than vertical sectioning because it enables the quantitative examination of hair follicles at different stages. Without having the quantitative data of normal scalp hair counts as controls, it is impossible to evaluate scalp biopsies for hair disorders. In recent years, trichoscope is more popular in analysis of hair disease. It is less invasive and simple. The aim of this study is to understand the pros and cons of trichoscpoe.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    men's hair count
    Arm Type
    Active Comparator
    Arm Title
    women's hair count
    Arm Type
    Placebo Comparator
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    photofinder levicam
    Intervention Description
    Exam frontal, bilateral Temporal and occipital scalp by photofinder levicam and compare the pros and cons with the data from scalp biopsy.
    Primary Outcome Measure Information:
    Title
    Average number of hairs
    Description
    Exam frontal, bilateral Temporal and occipital scalp by photofinder levicam
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Average hair shaft thickness
    Description
    Exam frontal, bilateral Temporal and occipital scalp by photofinder levicam
    Time Frame
    1 year
    Title
    Amount of Single, double and riple follicular unit
    Description
    Exam frontal, bilateral Temporal and occipital scalp by photofinder levicam
    Time Frame
    1year
    Title
    Amount of Empty hair follicles
    Description
    Exam frontal, bilateral Temporal and occipital scalp by photofinder levicam
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 20-50y/o adults without any scalp disorder Exclusion Criteria: adults with any scalp disorder

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    The Analysis of Hair Count in Healthy Taiwanese Persons by Trichoscope

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