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

NCT ID: NCT01052870

Last Updated: 2010-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2009-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Androgenetic Alopecia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Study Groups

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androgen receptor gene polymorphism

Medication response will be assessed according to androgen receptor genotype

Group Type OTHER

Finasteride

Intervention Type DRUG

Effect of 1 mg finasteride on women with androgenetic alopecia depending on their AR gene polymorphism (androgen sensitivity)

finasteride

medication for treating androgenetic alopecia in women

Group Type ACTIVE_COMPARATOR

Finasteride

Intervention Type DRUG

Effect of 1 mg finasteride on women with androgenetic alopecia depending on their AR gene polymorphism (androgen sensitivity)

Interventions

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Finasteride

Effect of 1 mg finasteride on women with androgenetic alopecia depending on their AR gene polymorphism (androgen sensitivity)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* women with hair loss

Exclusion Criteria

* pre menopausal,
* metabolic or medication or non-androgenetic causes of hair loss,
* diffuse hair loss
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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HairDx, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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HairDx

Principal Investigators

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Sharon A Keene, M.D.

Role: PRINCIPAL_INVESTIGATOR

HairDx, LLC

Other Identifiers

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HairDx2009

Identifier Type: -

Identifier Source: org_study_id

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