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
  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

Resource links provided by NLM:


Further study details as provided by HairDx, LLC:

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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01052870

Sponsors and Collaborators
HairDx, LLC
Investigators
Principal Investigator: Sharon A Keene, M.D. HairDx, LLC
  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:
Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
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 July 24, 2014