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