Clincosm LogoSign in Get a demo

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

Sponsor
HairDx, LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT01052870
Collaborator
(none)
12
Enrollment
2
Arms
12
Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Single
Primary Purpose:
Treatment
Official Title:
Study Evaluating the Association of CAG Repeat Polymorphisms and Finasteride Response in Women With Androgenetic Alopecia
Study Start Date :
Dec 1, 2008
Actual Primary Completion Date :
Dec 1, 2009
Actual Study Completion Date :
Dec 1, 2009

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    No locations specified.

    Sponsors and Collaborators

    • HairDx, LLC

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01052870
    Other Study ID Numbers:
    • HairDx2009
    First Posted:
    Jan 20, 2010
    Last Update Posted:
    Jan 20, 2010
    Last Verified:
    Jan 1, 2010
    Keywords provided by , ,
    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
    Finasteride

    Study Results

    No Results Posted as of Jan 20, 2010