Back to resultsAssociation of Polymorphisms in the Androgen Receptor Gene and Finasteride Response in Women With Androgenetic Alopecia
Primary Purpose
Androgenetic Alopecia
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Finasteride
Sponsored by
About this trial
This is an interventional treatment trial for Androgenetic Alopecia focused on measuring pharmacogenomics, androgen receptor gene, androgen sensitivity, CAG repeats, androgenetic alopecia, Pharmacogenomics in treatment for androgenetic alopecia in women
Eligibility Criteria
Inclusion Criteria:
- women with hair loss
Exclusion Criteria:
- pre menopausal,
- metabolic or medication or non-androgenetic causes of hair loss,
- diffuse hair loss
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Active Comparator
Arm Label
androgen receptor gene polymorphism
finasteride
Arm Description
Medication response will be assessed according to androgen receptor genotype
medication for treating androgenetic alopecia in women
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01052870
Brief Title
Association of Polymorphisms in the Androgen Receptor Gene and Finasteride Response in Women With Androgenetic Alopecia
Official Title
Study Evaluating the Association of CAG Repeat Polymorphisms and Finasteride Response in Women With Androgenetic Alopecia
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
HairDx, LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Androgenetic Alopecia
Keywords
pharmacogenomics, androgen receptor gene, androgen sensitivity, CAG repeats, androgenetic alopecia, Pharmacogenomics in treatment for androgenetic alopecia in women
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
androgen receptor gene polymorphism
Arm Type
Other
Arm Description
Medication response will be assessed according to androgen receptor genotype
Arm Title
finasteride
Arm Type
Active Comparator
Arm Description
medication for treating androgenetic alopecia in women
Intervention Type
Drug
Intervention Name(s)
Finasteride
Intervention Description
Effect of 1 mg finasteride on women with androgenetic alopecia depending on their AR gene polymorphism (androgen sensitivity)
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
women with hair loss
Exclusion Criteria:
pre menopausal,
metabolic or medication or non-androgenetic causes of hair loss,
diffuse hair loss
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon A Keene, M.D.
Organizational Affiliation
HairDx, LLC
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Association of Polymorphisms in the Androgen Receptor Gene and Finasteride Response in Women With Androgenetic Alopecia
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