Pharmacogenomic Study of Androgenetic Alopecia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Taipei Medical University WanFang Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Chang Gung Memorial Hospital
Information provided by:
Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier:
NCT01227031
First received: October 20, 2010
Last updated: November 10, 2010
Last verified: October 2010
  Purpose

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
Androgenetic Alopecia

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Pharmacogenomic Study of Androgenetic Alopecia

Resource links provided by NLM:


Further study details as provided by Taipei Medical University WanFang Hospital:

Biospecimen Retention:   Samples With DNA

DNA extraction from blood sample


Estimated Enrollment: 400
Study Start Date: October 2010
Estimated Study Completion Date: July 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Androgenetic alopecia (pattern hair loss)

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01227031

Contacts
Contact: Ren-Yu Tsai 886-2-29307930 ext 2980 b671022@tmu.edu.tw

Locations
Taiwan
Taipei Medical University-Wan Fang Hospital Not yet recruiting
Taipei, Taiwan
Contact: Ren-Yu Tsai    886-2-29307930 ext 2980    b671022@tmu.edu.tw   
Sponsors and Collaborators
Taipei Medical University WanFang Hospital
Chang Gung Memorial Hospital
Investigators
Principal Investigator: Ren-Yu Tsai Taipei Medical University-Wan Fang Hospital
  More Information

No publications provided

Responsible Party: Taipei Medical University-Wan Fang Hospital, Department of Dermatology, Taipei Medical University-Wan Fang Hospital
ClinicalTrials.gov Identifier: NCT01227031     History of Changes
Other Study ID Numbers: 98089
Study First Received: October 20, 2010
Last Updated: November 10, 2010
Health Authority: Taiwan: Department of Health

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

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

ClinicalTrials.gov processed this record on October 20, 2014