Androgenetic Alopecia in Fabry Disease

Completed

• Conditions: Fabry Disease

• Registration Number: NCT01295008
• Lead Sponsor: Baylor Research Institute

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.

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2011-02-10
• Study First Submitted QC: 2011-02-11
• Study First Posted: 2011-02-14
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-12
• Last Update Posted: 2016-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 107

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Baylor University Medical Center; 🇺🇸 Dallas, Texas, United States