NCT01295008

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 14, 2011

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

January 13, 2016

Status Verified

January 1, 2016

Enrollment Period

4.8 years

First QC Date

February 10, 2011

Last Update Submit

January 12, 2016

Conditions

Fabry Disease

Keywords

Fabry diseaseMale pattern baldnessAlopeciaGLA gene mutationAlpha-galactosidase A

Outcome Measures

Primary Outcomes (1)

  • No and frontal only androgenetic alopecia

    No and frontal only androgenetic alopecia opposed to vertex only and frontal and vertex androgenetic alopecia.

    1 Year

Secondary Outcomes (1)

  • Vertex only and frontal and vertex androgenetic alopecia.

    1 Year

Study Arms (2)

Patients with the classic form

Fabry disease and healthy controls

Eligibility Criteria

Age18 Years - 64 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Selected from specialy clinic

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

MeSH Terms

Conditions

Fabry DiseaseAlopecia

Condition Hierarchy (Ancestors)

SphingolipidosesLysosomal Storage Diseases, Nervous SystemBrain Diseases, Metabolic, InbornBrain Diseases, MetabolicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCerebral Small Vessel DiseasesCerebrovascular DisordersVascular DiseasesCardiovascular DiseasesGenetic Diseases, X-LinkedGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolism, Inborn ErrorsLipidosesLipid Metabolism, Inborn ErrorsLysosomal Storage DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesLipid Metabolism DisordersHypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Raphael Schiffmann, MD

    Baylor Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2011

First Posted

February 14, 2011

Study Start

December 1, 2010

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

January 13, 2016

Record last verified: 2016-01

Locations

US(1)