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Androgenetic Alopecia in Fabry Disease

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.
 
ClinicalTrials.gov Identifier: NCT01295008
Recruitment Status : Completed
First Posted : February 14, 2011
Last Update Posted : January 13, 2016
Sponsor:
Information provided by (Responsible Party):
Baylor Research Institute

Tracking Information
First Submitted Date February 10, 2011
First Posted Date February 14, 2011
Last Update Posted Date January 13, 2016
Study Start Date December 2010
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 11, 2011)
No and frontal only androgenetic alopecia [ Time Frame: 1 Year ]
No and frontal only androgenetic alopecia opposed to vertex only and frontal and vertex androgenetic alopecia.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 11, 2011)
Vertex only and frontal and vertex androgenetic alopecia. [ Time Frame: 1 Year ]
No and frontal only androgenetic alopecia opposed to vertex only and frontal and vertex androgenetic alopecia.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Androgenetic Alopecia in Fabry Disease
Official Title Androgenetic Alopecia in Fabry Disease
Brief Summary The purpose of this study is to assess whether patients with the classic form of Fabry disease have significantly less androgenic alopecia (male pattern baldness).
Detailed Description

Objectives: To test the hypothesis that adult males with classic form of Fabry disease have a significantly lower incidence of androgenic alopecia than matched controls.

Study Population: 120 patients aged 20-64 with Fabry disease that have GLA mutations or alpha-galactosidase A activity associated with no residual enzyme activity and non-Fabry male controls of the same age range and the same number of non-Fabry controls.

Design: This is a cross-sectional study comparing the prevalence of androgenic alopecia in two groups of subjects.

Outcome Measures: The levels of the outcome will be no androgenic alopecia and frontal only androgenetic alopecia opposed to vertex only and frontal and vertex androgenetic alopecia.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Selected from specialy clinic
Condition Fabry Disease
Intervention Not Provided
Study Groups/Cohorts
  • Patients with the classic form
  • Fabry disease and healthy controls
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 12, 2016)
107
Original Estimated Enrollment
 (submitted: February 11, 2011)
240
Actual Study Completion Date October 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Male patients with Fabry disease age 20-64 years old.
  • Healthy male controls age 20-64 years old
  • GLA gene mutations associated with the classic form of Fabry disease or having alpha-galactosidase A activity that is essentially zero
  • Patients who freely agree to participate in this study and understand the nature, risks and benefits of this study and give their written informed consent.
Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01295008
Other Study ID Numbers 010-308
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Baylor Research Institute
Study Sponsor Baylor Research Institute
Collaborators Not Provided
Investigators
Principal Investigator: Raphael Schiffmann, MD Baylor Research Institute
PRS Account Baylor Research Institute
Verification Date January 2016