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Androgenetic Alopecia in Fabry Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01295008
First Posted: February 14, 2011
Last Update Posted: January 13, 2016
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.
Information provided by (Responsible Party):
Baylor Research Institute
  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:


Further study details as provided by Baylor Research Institute:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 107
Study Start Date: December 2010
Study Completion Date: October 2015
Primary Completion Date: October 2015 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01295008


Locations
United States, Texas
Baylor University Medical Center
Dallas, Texas, United States, 75246
Sponsors and Collaborators
Baylor Research Institute
Investigators
Principal Investigator: Raphael Schiffmann, MD Baylor Research Institute
  More Information

Responsible Party: Baylor Research Institute
ClinicalTrials.gov Identifier: NCT01295008     History of Changes
Other Study ID Numbers: 010-308
First Submitted: February 10, 2011
First Posted: February 14, 2011
Last Update Posted: January 13, 2016
Last Verified: January 2016

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

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