HairDx Analytical Validation Study

NCT04379583 | Withdrawn FDA Device

• 1 other identifier: FI-HairDX-001
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hair Loss; Hair Loss/Baldness; Female Pattern Baldness; Androgenetic Alopecia

Outcome Measures

Primary Outcomes (2)

• Determination of the accuracy of the HairDx Test

  Determination of the accuracy of the HairDx Test in comparison to bi-directional Sanger sequencing

  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

  Baseline

Study Arms (1)

Subjects

Female subjects providing DNA saliva sample

Device: HairDx Sample Collection Kit

Interventions

HairDx Sample Collection Kit DEVICE

Saliva collection using FDA OTC cleared sample collection device

Subjects

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female over the age of 18
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female subjects recruited from an online advertisement approved by the IRB

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Applied Biology, Inc.: lead

Study Sites (1)

Applied Biology, Inc.

Irvine, California, 92614, United States

Location

Related Publications (1)

• 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.

  PMID: 24344880 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Saliva DNA sample

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• John McCoy, PhD

  Applied Biology, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2020
• First Posted: May 7, 2020
• Study Start: June 15, 2020
• Primary Completion: December 6, 2021
• Study Completion: December 6, 2021
• Last Updated: July 21, 2021

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)