NCT03937557

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2019

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 3, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

May 5, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2020

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 22, 2020

Completed
Last Updated

January 2, 2020

Status Verified

December 1, 2019

Enrollment Period

11 months

First QC Date

April 29, 2019

Last Update Submit

December 30, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Average number of hairs

    Exam frontal, bilateral Temporal and occipital scalp by photofinder levicam

    1 year

Secondary Outcomes (3)

  • Average hair shaft thickness

    1 year

  • Amount of Single, double and riple follicular unit

    1year

  • Amount of Empty hair follicles

    1 year

Study Arms (2)

men's hair count

ACTIVE COMPARATOR
Diagnostic Test: photofinder levicam

women's hair count

PLACEBO COMPARATOR
Diagnostic Test: photofinder levicam

Interventions

photofinder levicamDIAGNOSTIC_TEST

Exam frontal, bilateral Temporal and occipital scalp by photofinder levicam and compare the pros and cons with the data from scalp biopsy.

men's hair countwomen's hair count

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • y/o adults without any scalp disorder

You may not qualify if:

  • adults with any scalp disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Skin Diseases

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dermatologist

Study Record Dates

First Submitted

April 29, 2019

First Posted

May 3, 2019

Study Start

May 5, 2019

Primary Completion

April 5, 2020

Study Completion

April 22, 2020

Last Updated

January 2, 2020

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share