Association of Polymorphisms in the Androgen Receptor Gene and Finasteride Response in Women With Androgenetic Alopecia
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Purpose
Previous studies of finasteride treatment in women with hair loss have failed to show positive results, yet, some women have responded anecdotally. Given that polymorphisms of the androgen receptor gene which confer androgen sensitivity impact male response to finasteride therapy, it was hypothesized that the same polymorphism in women may identify the group that will respond. This study is designed to test the impact of finasteride therapy on hair loss in postmenopausal women.
| Condition | Intervention | Phase |
|---|---|---|
|
Androgenetic Alopecia |
Drug: Finasteride |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind Primary Purpose: Treatment |
| Official Title: | Study Evaluating the Association of CAG Repeat Polymorphisms and Finasteride Response in Women With Androgenetic Alopecia |
| Enrollment: | 12 |
| Study Start Date: | December 2008 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
androgen receptor gene polymorphism
Medication response will be assessed according to androgen receptor genotype
|
Drug: Finasteride
Effect of 1 mg finasteride on women with androgenetic alopecia depending on their AR gene polymorphism (androgen sensitivity)
|
|
Active Comparator: finasteride
medication for treating androgenetic alopecia in women
|
Drug: Finasteride
Effect of 1 mg finasteride on women with androgenetic alopecia depending on their AR gene polymorphism (androgen sensitivity)
|
Detailed Description:
Androgen sensitivity in the cell is determined by the number of Cytosine-Adenine-Guanine repeats in the Androgen Receptor gene. Lower CAG repeats have been associated in previous studies with androgenic conditions such as acne, hirsutism and hair loss in men and women. Keeping this in mind, we tested women with hair loss in the frontal or vertex area, for their AR genotype. Patients were randomized to placebo or 1 mg finasteride therapy for 6 months. Global photographs and 2 tatooed areas of 1cm2 each were measured monthly to assess global appearance and hair counts for medication impact.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- women with hair loss
Exclusion Criteria:
- pre menopausal,
- metabolic or medication or non-androgenetic causes of hair loss,
- diffuse hair loss
Contacts and Locations More Information
No publications provided
| Responsible Party: | Sharon Keene, M.D., HairDx |
| ClinicalTrials.gov Identifier: | NCT01052870 History of Changes |
| Other Study ID Numbers: | HairDx2009 |
| Study First Received: | January 16, 2010 |
| Last Updated: | January 19, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by HairDx, LLC:
|
pharmacogenomics, androgen receptor gene, androgen sensitivity, CAG repeats, androgenetic alopecia Pharmacogenomics in treatment for androgenetic alopecia in women |
Additional relevant MeSH terms:
|
Hair Diseases Skin Diseases Pathological Conditions, Anatomical Alopecia Alopecia Areata Hypotrichosis Androgens Finasteride |
Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions 5-alpha Reductase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013