- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01227031
Pharmacogenomic Study of Androgenetic Alopecia
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Taipei, Taiwan
- Taipei Medical University-Wan Fang Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Ren-Yu Tsai, Taipei Medical University-Wan Fang Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 98089
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Clinical Trials on Androgenetic Alopecia
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Veradermics, Inc.RecruitingAndrogenetic Alopecia | AGA | Hair Loss | Female Androgenetic Alopecia | Androgenetic Alopecia (AGA)United States
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Universitätsklinikum Hamburg-EppendorfRecruiting
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National Institute of Blood and Marrow Transplant...Pak Emirates Military HospitalEnrolling by invitationAndrogenetic Alopecia | Androgenetic Alopecia (AGA)Pakistan
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University of FloridaWithdrawnFemale Androgenetic AlopeciaUnited States
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Assiut UniversityNot yet recruitingAndrogenetic Alopecia | Androgenetic Alopecia (AGA)Egypt
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PDFE Pharma Innovations FZCOActive, not recruitingAlopecia, Androgenetic | Baldness | Androgenetic Alopecia (AGA)India
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Shanghai Zhongshan HospitalRecruitingAndrogenetic Alopecia (AGA)China
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Suzhou Kintor Pharmaceutical Inc,Suzhou Koshine Biomedica, Inc.Not yet recruitingAndrogenetic Alopecia (AGA)China
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Suzhou Kintor Pharmaceutical Inc,Completed
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Eurofarma Laboratorios S.A.Not yet recruitingAndrogenetic Alopecia | Androgenetic Alopecia (AGA)