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Association of Polymorphisms in the Androgen Receptor Gene and Finasteride Response in Women With Androgenetic Alopecia

This study has been completed.
Sponsor:
Information provided by:
HairDx, LLC
ClinicalTrials.gov Identifier:
NCT01052870
First received: January 16, 2010
Last updated: January 19, 2010
Last verified: January 2010

January 16, 2010
January 19, 2010
December 2008
December 2009   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01052870 on ClinicalTrials.gov Archive Site
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Association of Polymorphisms in the Androgen Receptor Gene and Finasteride Response in Women With Androgenetic Alopecia
Study Evaluating the Association of CAG Repeat Polymorphisms and Finasteride Response in Women With Androgenetic Alopecia

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
Androgenetic Alopecia
Drug: Finasteride
Effect of 1 mg finasteride on women with androgenetic alopecia depending on their AR gene polymorphism (androgen sensitivity)
  • androgen receptor gene polymorphism
    Medication response will be assessed according to androgen receptor genotype
    Intervention: Drug: Finasteride
  • Active Comparator: finasteride
    medication for treating androgenetic alopecia in women
    Intervention: Drug: Finasteride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
December 2009
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • women with hair loss

Exclusion Criteria:

  • pre menopausal,
  • metabolic or medication or non-androgenetic causes of hair loss,
  • diffuse hair loss
Female
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Yes
Contact information is only displayed when the study is recruiting subjects
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NCT01052870
HairDx2009
No
Sharon Keene, M.D., HairDx
HairDx, LLC
Not Provided
Principal Investigator: Sharon A Keene, M.D. HairDx, LLC
HairDx, LLC
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP