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Study no longer required by sponsor
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The HairDx Test reports genetic variants associated with the development of FPHL.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects | Female subjects providing DNA saliva sample |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HairDx Sample Collection Kit | Device | Saliva collection using FDA OTC cleared sample collection device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determination of the accuracy of the HairDx Test | 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 | Determination of the precision and reproducibility of HairDx Test in accordance with the laboratory instructions for use documentation | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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Female over the age of 18
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Female subjects recruited from an online advertisement approved by the IRB
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| Name | Affiliation | Role |
|---|---|---|
| John McCoy, PhD | Applied Biology, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Applied Biology, Inc. | Irvine | California | 92614 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24344880 | Background | 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. |
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Data will only be shared with FDA.
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| ID | Term |
|---|---|
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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Saliva DNA sample
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |