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Pharmacogenomic Study of Androgenetic Alopecia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01227031
Recruitment Status : Unknown
Verified October 2010 by Taipei Medical University WanFang Hospital.
Recruitment status was:  Not yet recruiting
First Posted : October 22, 2010
Last Update Posted : November 12, 2010
Chang Gung Memorial Hospital
Information provided by:
Taipei Medical University WanFang Hospital

Brief Summary:

Androgenic alopecia, the common form of hair loss is a highly heritable disorder of considerable social significance affecting around 40% of adult men and women. A variety of genetic and environmental factors are likely to play a role in androgenetic alopecia. Genetic variants in the human androgen receptor gene (AR) have been reported to be associated with AGA in Caucasians. Other genes involved with hair loss also have been found. One of them being a gene on chromosome 3 (3q26). A recent genome-wide association study in 296 individuals with male-pattern baldness and 347 controls had carried out and five SNPs on chromosome 20p11 were found to be highly significant association for AGA (rs2180439 combined P = 2.7 x 10(-15)). No interaction was detected with the X-chromosomal androgen receptor locus, suggesting that the 20p11 locus has a role in a yet-to-be-identified androgen-independent pathway.

The total number of evaluated patients with androgenic alopecia will be at least 300. All patients will be further grouped as good responders or poor responders to conventional medications, such as topical minoxidil and systemic finasteride. Candidate genes potentially involved in gout and its treatment response will be selected from the published literatures; specifically, two resources of candidate genes will be selected: (i) genes which are known to directly link with androgenic alopecia, and (ii) genes are potentially implicated in particular pathways of androgen/estrogen receptors, metabolism and downstream signals, and genes involved in anti-oxidants or hair growth. The SNP genotyping will be performed by MALDI-TOF Mass Spectrometry. Data analysis will be performed by comparing SNPs allele frequency between good responder and poor responder to conventional medications of patients with androgenic alopecia and further comparing to the allele frequency of SNPs in healthy controls. A functional study will also be done to prove the genetic association.

Condition or disease
Androgenetic Alopecia

Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Pharmacogenomic Study of Androgenetic Alopecia
Study Start Date : October 2010
Primary Completion Date : October 2010
Estimated Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Biospecimen Retention:   Samples With DNA
DNA extraction from blood sample

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Androgenetic alopecia (pattern hair loss)

Inclusion Criteria:

  • Willing to sign inform consent form
  • Willing to received history taking by telephone or interview
  • Diagnosed androgenetic alopecia by Hamilton-Norwood classification
  • More than 20 year-old, both sex

Exclusion Criteria:

  • Ever had trauma over alopecia area
  • Cancer, infection, or other systemic disease that might interfere diagnosis
  • Unconfirmed diagnosis clinically or pathologically.

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 identifier (NCT number): NCT01227031

Contact: Ren-Yu Tsai 886-2-29307930 ext 2980

Taipei Medical University-Wan Fang Hospital Not yet recruiting
Taipei, Taiwan
Contact: Ren-Yu Tsai    886-2-29307930 ext 2980   
Sponsors and Collaborators
Taipei Medical University WanFang Hospital
Chang Gung Memorial Hospital
Principal Investigator: Ren-Yu Tsai Taipei Medical University-Wan Fang Hospital

Responsible Party: Taipei Medical University-Wan Fang Hospital, Department of Dermatology, Taipei Medical University-Wan Fang Hospital Identifier: NCT01227031     History of Changes
Other Study ID Numbers: 98089
First Posted: October 22, 2010    Key Record Dates
Last Update Posted: November 12, 2010
Last Verified: October 2010

Keywords provided by Taipei Medical University WanFang Hospital:
Genetic susceptibility of androgenetic alopecia
Genetic difference in Finasteride response

Additional relevant MeSH terms:
Alopecia Areata
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical