HairDx Analytical Validation Study

July 20, 2021 updated by: Applied Biology, Inc.
The HairDx Test reports genetic variants associated with the development of FPHL.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Irvine, California, United States, 92614
        • Applied Biology, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Female subjects recruited from an online advertisement approved by the IRB

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline
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
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Applied Biology, Inc.

Investigators

  • Principal Investigator: John McCoy, PhD, Applied Biology, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2020

Primary Completion (Anticipated)

December 6, 2021

Study Completion (Anticipated)

December 6, 2021

Study Registration Dates

First Submitted

May 5, 2020

First Submitted That Met QC Criteria

May 5, 2020

First Posted (Actual)

May 7, 2020

Study Record Updates

Last Update Posted (Actual)

July 21, 2021

Last Update Submitted That Met QC Criteria

July 20, 2021

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FI-HairDX-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Data will only be shared with FDA.

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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