Hair LossNCT04379583
HairDx Analytical Validation Study
An observational study of Hair Loss and Hair Loss/Baldness, run by Applied Biology, Inc. at 1 site in United States.
Trial summary
The HairDx Test reports genetic variants associated with the development of FPHL. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hair Loss, Hair Loss/Baldness, Female Pattern Baldness
- What is being tested?
- HairDx Sample Collection Kit
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2020to 6 Dec 2021
- Phase
- Observational
- 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 18 years and older
- Women only
- Adult, Older adult
Study population: Female subjects recruited from an online advertisement approved by the IRB
Who may be able to join
- Females over the age of 18
- Overall good health
- Able to give informed consent
- Willing to collect saliva sample
Who cannot join
- Xerostomia (dry mouth)
- Inability to provide informed consent in English
- Inability to follow instructions for saliva sample collection
- Non US resident
Trial locations and contacts
1 site in 1 country.
About this study
The HairDx Test reports genetic variants associated with the development of FPHL.
Read the detailed description
The HairDx Test reports genetic variants associated with the development of FPHL. The variants are detected from a saliva sample collected at home. The HairDx Test report is designed to help individuals understand the meaning of their results and encourage a conversation with a healthcare professional. The information provided by the HairDx Test report is not intended to start, stop or change any course of treatment. The purpose of this study is to collect DNA samples from subjects. The DNA samples will be used for the analytical validation of the HairDx Test. The results of this study will not be shared with the subjects.
- Being tested
- HairDx Sample Collection Kit
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HairDx Sample Collection KitDevice
Saliva collection using FDA OTC cleared sample collection device
| Study group | Role | What they receive |
|---|---|---|
| Subjects | Female subjects providing DNA saliva sample Receives: Device: HairDx Sample Collection Kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of the accuracy of the HairDx Test
Determination of the accuracy of the HairDx Test in comparison to bi-directional Sanger sequencing
Measured: Baseline
Determination of the precision and reproducibility of HairDx Test
Determination of the precision and reproducibility of HairDx Test in accordance with the laboratory instructions for use documentation
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2020
- Study start15 Jun 2020
- Primary completion6 Dec 2021 (estimated)
- Study completion6 Dec 2021 (estimated)
Why it stopped: Study no longer required by sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hair LossStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Applied Biology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John McCoy, PhD, Principal investigator, Applied Biology, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04379583
- Sponsor's protocol ID
- FI-HairDX-001
- Status last verified
- May 2020
- First submitted
- 5 May 2020
- Last updated
- 21 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Data will only be shared with FDA.
Publications
Redler S, Birch P, Drichel D, Hofmann P, Dobson K, Bohmer AC, Becker J, Giehl KA, Tazi-Ahnini R, Kruse R, Wolff H, Miesel A, Fischer T, Bohm M, Nuwayhid R, Garcia Bartels N, Lutz G, Becker T, Blume-Peytavi U, Nothen MM, Messenger AG, Betz RC. The oestrogen receptor 2 (ESR2) gene in female-pattern hair loss: replication of association with rs10137185 in German patients. Br J Dermatol. 2014 Apr;170(4):982-5. doi: 10.1111/bjd.12756. No abstract available.
PubMed 24344880
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HairDx Analytical Validation Study
- ClinicalTrials.gov ID
- NCT04379583
- Acronym / sponsor ID
- FI-HairDX-001
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study no longer required by sponsor
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Applied Biology, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 6 Dec 2021 (estimated)
- Study completion
- 6 Dec 2021 (estimated)
- First posted
- 7 May 2020 (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.
The HairDx Test reports genetic variants associated with the development of FPHL.
Detailed description
The HairDx Test reports genetic variants associated with the development of FPHL. The variants are detected from a saliva sample collected at home. The HairDx Test report is designed to help individuals understand the meaning of their results and encourage a conversation with a healthcare professional. The information provided by the HairDx Test report is not intended to start, stop or change any course of treatment. The purpose of this study is to collect DNA samples from subjects. The DNA samples will be used for the analytical validation of the HairDx Test. The results of this study will not be shared with the subjects.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects | – | Device: HairDx Sample Collection KitFemale subjects providing DNA saliva sample |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Female subjects recruited from an online advertisement approved by the IRB
Key inclusion criteria (4 listed)
- Females over the age of 18
- Overall good health
- Able to give informed consent
- Willing to collect saliva sample
Key exclusion criteria (4 listed)
- Xerostomia (dry mouth)
- Inability to provide informed consent in English
- Inability to follow instructions for saliva sample collection
- Non US resident
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 |
|---|---|---|
| HairDx Sample Collection KitSaliva collection using FDA OTC cleared sample collection device | Device | Subjects |
Primary outcome
Determination of the accuracy of the HairDx Test
Time frame: Baseline
Determination of the accuracy of the HairDx Test in comparison to bi-directional Sanger sequencing
Determination of the precision and reproducibility of HairDx Test
Time frame: Baseline
Determination of the precision and reproducibility of HairDx Test in accordance with the laboratory instructions for use documentation
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 21 Jul 2021.
- Background: PubMed 24344880Redler S, Birch P, Drichel D, Hofmann P, Dobson K, Bohmer AC, Becker J, Giehl KA, Tazi-Ahnini R, Kruse R, Wolff H, Miesel A, Fischer T, Bohm M, Nuwayhid R, Garcia Bartels N, Lutz G, Becker T, Blume-Peytavi U, Nothen MM, Messenger AG, Betz RC. The oestrogen receptor 2 (ESR2) gene in female-pattern hair loss: replication of association with rs10137185 in German patients. Br J Dermatol. 2014 Apr;170(4):982-5. doi: 10.1111/bjd.12756. No abstract available.
- Individual participant dataSharing planned: No. Data will only be shared with FDA.
Related trials for Hair Loss
Enrolling by invitation
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RecruitingPhase 3
A Study to Evaluate the Safety and Effectiveness of Upadacitinib in Pediatric Participants With Alopecia Areata
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A Study in Young People and Adults to Learn About the Medicine Ritlecitinib for Treatment of Patchy Hair Loss, Known by the Medical Term as Moderate Alopecia Areata
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RecruitingPhase 2
Evaluate the Efficacy and Safety of Ruxolitinib on Hair Regrowth in Patients With Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (APECED)-Associated Alopecia Areata
Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (Apeced), Alopecia Areata
Recruiting
Study to Assess the Ability of the Portable Scalp Cooling System (PSCS) to Prevent Hair Loss
Alopecia, Chemotherapy-induced Alopecia
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.
John McCoy, PhD principal investigator
Applied Biology, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hair Loss and Hair Loss/Baldness, run by Applied Biology, Inc. at 1 site in United States.
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 4 inclusion and 4 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 21 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Determination of the accuracy of the HairDx Test (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04379583, which also lists 1 linked publication.
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 21 Jul 2021.