Androgenetic Alopecia in Fabry Disease

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01295008

Enrollment

107

Registered

2011-02-14

Start date

2010-12-31

Completion date

2015-10-31

Last updated

2016-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fabry Disease

Keywords

Fabry disease, Male pattern baldness, Alopecia, GLA gene mutation, Alpha-galactosidase A

Brief summary

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).

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

MALE

Age

18 Years to 64 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
No and frontal only androgenetic alopecia	1 Year	No and frontal only androgenetic alopecia opposed to vertex only and frontal and vertex androgenetic alopecia.

Secondary

Measure	Time frame	Description
Vertex only and frontal and vertex androgenetic alopecia.	1 Year	No and frontal only androgenetic alopecia opposed to vertex only and frontal and vertex androgenetic alopecia.

Countries

United States

Outcome results