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

January 19, 2010 updated by: HairDx, LLC

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • women with hair loss

Exclusion Criteria:

  • pre menopausal,
  • metabolic or medication or non-androgenetic causes of hair loss,
  • diffuse hair loss

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HairDx, LLC

Investigators

  • Principal Investigator: Sharon A Keene, M.D., HairDx, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (ACTUAL)

December 1, 2009

Study Completion (ACTUAL)

December 1, 2009

Study Registration Dates

First Submitted

January 16, 2010

First Submitted That Met QC Criteria

January 19, 2010

First Posted (ESTIMATE)

January 20, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

January 20, 2010

Last Update Submitted That Met QC Criteria

January 19, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HairDx2009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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