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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Recruitment Status : Withdrawn (Study no longer required by sponsor)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.

Tracking Information
First Submitted Date May 5, 2020
First Posted Date May 7, 2020
Last Update Posted Date July 21, 2021
Actual Study Start Date June 15, 2020
Estimated Primary Completion Date December 6, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 6, 2020)
  • 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
  • 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
Original Primary Outcome Measures
 (submitted: May 5, 2020)
  • 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
  • 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 IFU
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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
Study Design Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Saliva DNA sample
Sampling Method Non-Probability Sample
Study Population Female subjects recruited from an online advertisement approved by the IRB
Condition
  • Hair Loss
  • Hair Loss/Baldness
  • Female Pattern Baldness
  • Androgenetic Alopecia
Intervention Device: HairDx Sample Collection Kit
Saliva collection using FDA OTC cleared sample collection device
Study Groups/Cohorts Subjects
Female subjects providing DNA saliva sample
Intervention: Device: HairDx Sample Collection Kit
Publications * Redler S, Birch P, Drichel D, Hofmann P, Dobson K, Bohmer AC, Becker J, Giehl KA, Tazi-Ahnini R, Kruse R, Wolff H, Miesel A, Fischer T, Bohm M, Nuwayhid R, Garcia Bartels N, Lutz G, Becker T, Blume-Peytavi U, Nothen MM, Messenger AG, Betz RC. The oestrogen receptor 2 (ESR2) gene in female-pattern hair loss: replication of association with rs10137185 in German patients. Br J Dermatol. 2014 Apr;170(4):982-5. doi: 10.1111/bjd.12756. No abstract available.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: July 20, 2021)
0
Original Estimated Enrollment
 (submitted: May 5, 2020)
200
Estimated Study Completion Date December 6, 2021
Estimated Primary Completion Date December 6, 2021   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Female over the age of 18
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04379583
Other Study ID Numbers FI-HairDX-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: Data will only be shared with FDA.
Current Responsible Party Applied Biology, Inc.
Original Responsible Party Same as current
Current Study Sponsor Applied Biology, Inc.
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: John McCoy, PhD Applied Biology, Inc.
PRS Account Applied Biology, Inc.
Verification Date May 2020