NCT01398813

Brief Summary

In this survey of X-Lined Hypohidrotic Ectodermal Dysplasia (XLHED) carrier females, Edimer proposes to review responses to an XLHED Carrier Outlook toward Reproduction Survey in order to understand attitudes toward reproduction, potential treatments and genetic testing in order to improve the understanding of the decisions that XLHED carrier females make regarding their reproductive future.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2011

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

July 19, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 21, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

July 9, 2013

Status Verified

July 1, 2013

Enrollment Period

2 years

First QC Date

July 19, 2011

Last Update Submit

July 7, 2013

Conditions

Hypohidrotic Ectodermal DysplasiaX-Linked Hypohidrotic Ectodermal Dysplasia

Keywords

HEDXLHED

Outcome Measures

Primary Outcomes (1)

  • To study the outlook of XLHED carrier females toward reproduction, potential XLHED treatments and genetic testing.

    Survey results will be collected during the 1 day of subject involvement.

    study day 1

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study will enroll XLHED carrier females

You may qualify if:

  • Provide signed informed consent;
  • years of age or older
  • Females with:
  • the clinical characteristics of HED, including at least two of the following characteristics:
  • clinical signs and symptoms of HED:
  • a history of decreased sweating;
  • abnormal teeth (fewer permanent teeth, teeth are smaller than average and often have conical crowns);
  • sparseness of scalp and body hair;
  • AND
  • a clinical diagnosis from a healthcare professional;
  • or at least one HED affected family member
  • OR genetically confirmed HED or XLHED;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carrie Milliard

Portland, Maine, 04103, United States

Location

MeSH Terms

Conditions

Ectodermal Dysplasia 1, Anhidrotic

Condition Hierarchy (Ancestors)

Ectodermal DysplasiaAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin AbnormalitiesGenetic Diseases, X-LinkedGenetic Diseases, InbornSkin Diseases, GeneticSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Carrie Milliard, CGC

    Maine Medical Partners Pediatric Specialty Care

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2011

First Posted

July 21, 2011

Study Start

July 1, 2011

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

July 9, 2013

Record last verified: 2013-07

Locations

US(1)