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NCT04379583 Clinical Trial

HairDx Analytical Validation Study

Androgenetic Alopecia Clinical Trial

Official title:
HairDx Analytical Validation Study

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT04379583
Other study ID # FI-HairDX-001
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date June 15, 2020
Est. completion date December 6, 2021

Study information
Verified date May 2020
Source Applied Biology, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date December 6, 2021
Est. primary completion date December 6, 2021
Accepts healthy volunteers
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• HairDx Sample Collection Kit
Saliva collection using FDA OTC cleared sample collection device

Locations
Country Name City State
United States Applied Biology, Inc. Irvine California

Sponsors (1)
Lead Sponsor Collaborator
Applied Biology, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Redler S, Birch P, Drichel D, Hofmann P, Dobson K, Böhmer AC, Becker J, Giehl KA, Tazi-Ahnini R, Kruse R, Wolff H, Miesel A, Fischer T, Böhm M, Nuwayhid R, Garcia Bartels N, Lutz G, Becker T, Blume-Peytavi U, Nöthen 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Determination of the accuracy of the HairDx Test Determination of the accuracy of the HairDx Test in comparison to bi-directional Sanger sequencing Baseline
Primary 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
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