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Androgenetic Alopecia in Fabry Disease

This study is currently recruiting participants.
Verified August 2012 by Baylor Research Institute
Sponsor:
Information provided by (Responsible Party):
Baylor Research Institute
ClinicalTrials.gov Identifier:
NCT01295008
First received: February 10, 2011
Last updated: August 28, 2012
Last verified: August 2012
History of Changes
  Purpose

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).


Condition
Fabry Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Androgenetic Alopecia in Fabry Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Baylor Research Institute:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 240
Study Start Date: December 2010
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with the classic form
Fabry disease and healthy controls

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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Selected from specialy clinic

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01295008

Contacts
Contact: Caren Swift, RN (214) 820-4857 Caren.Swift@baylorhealth.edu

Locations
United States, Texas
Baylor University Medical Center Recruiting
Dallas, Texas, United States, 75246
Contact: Caren Swift, RN     214-820-4857     Caren.Swift@baylorhealth.edu    
Principal Investigator: Raphael Schiffmann, MD            
Sponsors and Collaborators
Baylor Research Institute
Investigators
Principal Investigator: Raphael Schiffmann, MD Baylor Research Institute
  More Information

No publications provided

Responsible Party: Baylor Research Institute
ClinicalTrials.gov Identifier: NCT01295008     History of Changes
Other Study ID Numbers: 010-308
Study First Received: February 10, 2011
Last Updated: August 28, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Baylor Research Institute:
Fabry disease
Male pattern baldness
Alopecia
GLA gene mutation
Alpha-galactosidase A

Additional relevant MeSH terms:
Fabry Disease
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Lysosomal Storage Diseases, Nervous System
Brain Diseases, Metabolic, Inborn
Brain Diseases, Metabolic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Genetic Diseases, X-Linked
 Genetic Diseases, Inborn
Lysosomal Storage Diseases
Metabolic Diseases
Lipid Metabolism Disorders
Alopecia
Alopecia Areata
Hypotrichosis
Sphingolipidoses
Metabolism, Inborn Errors
Lipidoses
Lipid Metabolism, Inborn Errors

ClinicalTrials.gov processed this record on May 16, 2013