HairDx Analytical Validation Study

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Androgenetic alopecia
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Brief Title

HairDx Analytical Validation Study

Official Title

HairDx Analytical Validation Study

Brief Summary

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

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

Primary Outcome

Determination of the accuracy of the HairDx Test

Condition

Hair Loss

Intervention

HairDx Sample Collection Kit

Study Arms / Comparison Groups

 Subjects
Description:  Female subjects providing DNA saliva sample

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Device

Estimated Enrollment

200

Start Date

June 15, 2020

Completion Date

June 6, 2021

Primary Completion Date

June 6, 2021

Eligibility 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

Gender

Female

Ages

18 Years - N/A

Contacts

John McCoy, PhD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT04379583

Organization ID

FI-HairDX-001

Responsible Party

Sponsor

Study Sponsor

Applied Biology, Inc.

Study Sponsor

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

Verification Date

May 2020