Pharmacogenomic Study of Androgenetic Alopecia

Sponsor
Taipei Medical University WanFang Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01227031
Collaborator
Chang Gung Memorial Hospital (Other)
400
1
9
44.6

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    400 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Pharmacogenomic Study of Androgenetic Alopecia
    Study Start Date :
    Oct 1, 2010
    Actual Primary Completion Date :
    Oct 1, 2010
    Anticipated Study Completion Date :
    Jul 1, 2011

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      20 Years to 80 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      Yes
      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

      Locations

      Site City State Country Postal Code
      1 Taipei Medical University-Wan Fang Hospital Taipei Taiwan

      Sponsors and Collaborators

      • Taipei Medical University WanFang Hospital
      • Chang Gung Memorial Hospital

      Investigators

      • Principal Investigator: Ren-Yu Tsai, Taipei Medical University-Wan Fang Hospital

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT01227031
      Other Study ID Numbers:
      • 98089
      First Posted:
      Oct 22, 2010
      Last Update Posted:
      Nov 12, 2010
      Last Verified:
      Oct 1, 2010

      Study Results

      No Results Posted as of Nov 12, 2010