HairDx Analytical Validation Study

Withdrawn

• Conditions: Hair Loss/Baldness; Hair Loss; Female Pattern Baldness; Androgenetic Alopecia
• Interventions: Device: HairDx Sample Collection Kit

• Registration Number: NCT04379583
• Lead Sponsor: Applied Biology, Inc.

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 Timeline

• Status Verified: 2020-05
• Study First Submitted: 2020-05-05
• Study First Submitted QC: 2020-05-05
• Study First Posted: 2020-05-07
• Study Start: 2020-06-15
• Last Update Submitted: 2021-07-20
• Last Update Posted: 2021-07-21
• Primary Completion: 2021-12-06
• Study Completion: 2021-12-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects	HairDx Sample Collection Kit	Female subjects providing DNA saliva sample

Primary Outcome Measures

Name	Time	Method
Determination of the precision and reproducibility of HairDx Test	Baseline	Determination of the precision and reproducibility of HairDx Test in accordance with the laboratory instructions for use documentation
Determination of the accuracy of the HairDx Test	Baseline	Determination of the accuracy of the HairDx Test in comparison to bi-directional Sanger sequencing

Trial Locations

Locations (1)

Applied Biology, Inc.; 🇺🇸 Irvine, California, United States