HairDx Analytical Validation Study

NCT ID: NCT04379583

Last Updated: 2021-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-15

Study Completion Date

2021-12-06

Brief Summary

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The HairDx Test reports genetic variants associated with the development of FPHL.

Detailed Description

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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.

Conditions

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Hair Loss Hair Loss/Baldness Female Pattern Baldness Androgenetic Alopecia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Subjects

Female subjects providing DNA saliva sample

HairDx Sample Collection Kit

Intervention Type DEVICE

Saliva collection using FDA OTC cleared sample collection device

Interventions

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HairDx Sample Collection Kit

Saliva collection using FDA OTC cleared sample collection device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Females over the age of 18
* Overall good health
* Able to give informed consent
* Willing to collect saliva sample

Exclusion Criteria

* Xerostomia (dry mouth)
* Inability to provide informed consent in English
* Inability to follow instructions for saliva sample collection
* Non US resident
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Applied Biology, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John McCoy, PhD

Role: PRINCIPAL_INVESTIGATOR

Applied Biology, Inc.

Locations

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Applied Biology, Inc.

Irvine, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 24344880 (View on PubMed)

Other Identifiers

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FI-HairDX-001

Identifier Type: -

Identifier Source: org_study_id

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