DermatosisNCT03937557
The Analysis of Hair Count in Healthy Taiwanese Persons by Trichoscope
A study testing photofinder levicam in people with Dermatosis, run by Shin Kong Wu Ho-Su Memorial Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Dermatosis
- What is being tested?
- photofinder levicam
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 5 May 2019to 22 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 20-50y/o adults without any scalp disorder
Who cannot join
- adults with any scalp disorder
About this study
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.
- Conditions
- Dermatosis
- Being tested
- photofinder levicam
- Medical subject headings
- Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| men's hair count | Active comparator | Not described Receives: Diagnostic Test: photofinder levicam |
| women's hair count | Placebo comparator | Not described Receives: Diagnostic Test: photofinder levicam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average number of hairs
Exam frontal, bilateral Temporal and occipital scalp by photofinder levicam
Measured: 1 year
Secondary outcomes (3)
Average hair shaft thickness
Exam frontal, bilateral Temporal and occipital scalp by photofinder levicam
Measured: 1 year
Amount of Single, double and riple follicular unit
Exam frontal, bilateral Temporal and occipital scalp by photofinder levicam
Measured: 1year
Amount of Empty hair follicles
Exam frontal, bilateral Temporal and occipital scalp by photofinder levicam
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2019
- Study start5 May 2019 (estimated)
- Primary completion5 Apr 2020 (estimated)
- Study completion22 Apr 2020 (estimated)
Why it stopped: Insufficient funds
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DermatosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shin Kong Wu Ho-Su Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chu Gong Yau, Shin Kong Wu Ho-Su Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03937557
- Sponsor's protocol ID
- 20190202R
- Status last verified
- Dec 2019
- First submitted
- 29 Apr 2019
- Last updated
- 2 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Analysis of Hair Count in Healthy Taiwanese Persons by Trichoscope
- ClinicalTrials.gov ID
- NCT03937557
- Acronym / sponsor ID
- 20190202R
- Conditions
- Dermatosis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Insufficient funds
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Shin Kong Wu Ho-Su Memorial HospitalUniversity, hospital or other
- Study start
- 5 May 2019 (estimated)
- Primary completion
- 5 Apr 2020 (estimated)
- Study completion
- 22 Apr 2020 (estimated)
- First posted
- 3 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| men's hair count | Active comparator | Diagnostic Test: photofinder levicam |
| women's hair count | Placebo comparator | Diagnostic Test: photofinder levicam |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 20-50y/o adults without any scalp disorder
Key exclusion criteria (1 listed)
- adults with any scalp disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| photofinder levicamExam frontal, bilateral Temporal and occipital scalp by photofinder levicam and compare the pros and cons with the data from scalp biopsy. | Diagnostic test | men's hair count, women's hair count |
Primary outcome
Average number of hairs
Time frame: 1 year
Exam frontal, bilateral Temporal and occipital scalp by photofinder levicam
3 secondary outcomes
Average hair shaft thickness
Time frame: 1 year
Amount of Single, double and riple follicular unit
Time frame: 1year
Amount of Empty hair follicles
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing photofinder levicam in people with Dermatosis, run by Shin Kong Wu Ho-Su Memorial Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average number of hairs (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2020.