Androgenetic Alopecia in Fabry Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Baylor Research Institute
Sponsor:
Information provided by (Responsible Party):
Baylor Research Institute
ClinicalTrials.gov Identifier:
NCT01295008
First received: February 10, 2011
Last updated: March 21, 2014
Last verified: March 2014

February 10, 2011
March 21, 2014
December 2010
December 2014   (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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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
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  • 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.
 
Recruiting
240
Not Provided
December 2014   (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
Yes
Contact: Caren Swift, RN (214) 820-4857 Caren.Swift@baylorhealth.edu
United States
 
NCT01295008
010-308
No
Baylor Research Institute
Baylor Research Institute
Not Provided
Principal Investigator: Raphael Schiffmann, MD Baylor Research Institute
Baylor Research Institute
March 2014

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