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Androgenetic Alopecia in Fabry Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Baylor Research Institute
ClinicalTrials.gov Identifier:
NCT01295008
First received: February 10, 2011
Last updated: January 12, 2016
Last verified: January 2016

February 10, 2011
January 12, 2016
December 2010
October 2015   (final data collection date for primary outcome measure)
No and frontal only androgenetic alopecia [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
No and frontal only androgenetic alopecia opposed to vertex only and frontal and vertex androgenetic alopecia.
Same as current
Complete list of historical versions of study NCT01295008 on ClinicalTrials.gov Archive Site
Vertex only and frontal and vertex androgenetic alopecia. [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
No and frontal only androgenetic alopecia opposed to vertex only and frontal and vertex androgenetic alopecia.
Same as current
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Not Provided
 
Androgenetic Alopecia in Fabry Disease
Androgenetic Alopecia in Fabry Disease
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).

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.

Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
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Non-Probability Sample
Selected from specialy clinic
Fabry Disease
Not Provided
  • Patients with the classic form
  • Fabry disease and healthy controls
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
107
October 2015
October 2015   (final data collection date for primary outcome measure)

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.
Male
18 Years to 64 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01295008
010-308
No
Not Provided
Not Provided
Baylor Research Institute
Baylor Research Institute
Not Provided
Principal Investigator: Raphael Schiffmann, MD Baylor Research Institute
Baylor Research Institute
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP