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HairDx Analytical Validation Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04379583
Recruitment Status : Withdrawn (Study no longer required by sponsor)
First Posted : May 7, 2020
Last Update Posted : July 21, 2021
Sponsor:
Information provided by (Responsible Party):
Applied Biology, Inc.

Study Description
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Brief Summary:
The HairDx Test reports genetic variants associated with the development of FPHL.

Condition or disease Intervention/treatment
Hair Loss Hair Loss/Baldness Female Pattern Baldness Androgenetic Alopecia Device: HairDx Sample Collection Kit

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
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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: HairDx Analytical Validation Study
Actual Study Start Date : June 15, 2020
Estimated Primary Completion Date : December 6, 2021
Estimated Study Completion Date : December 6, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Subjects
Female subjects providing DNA saliva sample
 Device: HairDx Sample Collection Kit
Saliva collection using FDA OTC cleared sample collection device


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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


Biospecimen Retention:   Samples With DNA
Saliva DNA sample

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female over the age of 18
Sampling Method:   Non-Probability Sample
Study Population
Female subjects recruited from an online advertisement approved by the IRB
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04379583


Locations
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United States, California
Applied Biology, Inc.
Irvine, California, United States, 92614
Sponsors and Collaborators
Applied Biology, Inc.
Investigators
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Principal Investigator: John McCoy, PhD Applied Biology, Inc.
More Information
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Publications:

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Responsible Party: Applied Biology, Inc.
ClinicalTrials.gov Identifier: NCT04379583    
Other Study ID Numbers: FI-HairDX-001
First Posted: May 7, 2020    Key Record Dates
Last Update Posted: July 21, 2021
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will only be shared with FDA.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
 Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical