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

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ClinicalTrials.gov Identifier: NCT01052870
Recruitment Status : Completed
First Posted : January 20, 2010
Last Update Posted : January 20, 2010
Sponsor:
Information provided by:

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
Androgenetic Alopecia Drug: Finasteride 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  (Clinical Trial)
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 : December 2008
Primary Completion Date : December 2009
Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Finasteride
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01052870


Sponsors and Collaborators
HairDx, LLC
Investigators
Principal Investigator: Sharon A Keene, M.D. HairDx, LLC
More Information

Responsible Party: Sharon Keene, M.D., HairDx
ClinicalTrials.gov Identifier: NCT01052870     History of Changes
Other Study ID Numbers: HairDx2009
First Posted: January 20, 2010    Key Record Dates
Last Update Posted: January 20, 2010
Last Verified: January 2010

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
Ascorbic Acid
Estrogens, Conjugated (USP)
Methyltestosterone
Finasteride
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Vitamins
Micronutrients
Growth Substances
Estrogens
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents
5-alpha Reductase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Hormone Antagonists
Urological Agents