Androgenetic Alopecia in Fabry Disease | Clinical Trial

Key information

Conditions

Fabry Disease Alopecia Brain Diseases Brain Diseases, Metabolic Brain Diseases, Metabolic, Inborn Cardiovascular Diseases Central Nervous System Diseases Cerebral Small Vessel Diseases Cerebrovascular Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Hair Diseases Hypotrichosis Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Lipidoses Lysosomal Storage Diseases Lysosomal Storage Diseases, Nervous System Metabolic Diseases Metabolism, Inborn Errors Nervous System Diseases Nutritional and Metabolic Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases Sphingolipidoses Vascular Diseases

Age range

18 year–64 year

Sex eligibility

Male

Study type

Observational

Primary location

Baylor University Medical Center

Dallas, Texas, 75246, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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 outcomes

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.

Sponsors and collaborators

Lead sponsor

Baylor Research Institute

Other

Registry information

Important dates

Study start: 2010
Primary completion: 2015
Study completion: 2015
First posted: Feb 14, 2011
Registry last updated: Jan 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed