Androgenetic Alopecia in Fabry Disease

Fabry Disease Clinical Trial

Official title:

Androgenetic Alopecia in Fabry Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01295008
• Other study ID #: 010-308
• Status: Completed
• Phase: N/A
• First received: February 10, 2011
• Last updated: January 12, 2016
• Start date: December 2010
• Est. completion date: October 2015

Study information

• Verified date: January 2016
• Source: Baylor Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 64 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Alopecia
• Fabry Disease

Locations

Country	Name	City	State
United States	Baylor University Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	No and frontal only androgenetic alopecia	No and frontal only androgenetic alopecia opposed to vertex only and frontal and vertex androgenetic alopecia.	1 Year	No
Secondary	Vertex only and frontal and vertex androgenetic alopecia.	No and frontal only androgenetic alopecia opposed to vertex only and frontal and vertex androgenetic alopecia.	1 Year	No