X-Linked Hypohidrotic Ectodermal Dysplasia (XLHED) Carrier Outlook Toward Reproduction Survey

X-Linked Hypohidrotic Ectodermal Dysplasia Clinical Trial

— X-CORS  

Official title:

Survey of X-Linked Hypohidrotic Ectodermal Dysplasia Carrier Women's Outlook Towards Reproduction, Potential XLHED Treatments and Genetic Testing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01398813
• Other study ID #: ECP-008
• Status: Completed
• Phase: N/A
• First received: July 19, 2011
• Last updated: July 7, 2013
• Start date: July 2011
• Est. completion date: July 2013

Study information

• Verified date: July 2013
• Source: Edimer Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Description:

The full survey is available here: https://www.surveymonkey.com/s/X-CORS

For more questions or more details you may contact the Principal Investigator, Carrie Milliard: MILLIC@mmc.org or 207-662-6712

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Provide signed informed consent;

2. 18 years of age or older

3. 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;

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Ectodermal Dysplasia
• Hypohidrotic Ectodermal Dysplasia
• X-Linked Hypohidrotic Ectodermal Dysplasia

Locations

Country	Name	City	State
United States	Carrie Milliard	Portland	Maine

Sponsors (1)

Lead Sponsor	Collaborator
Edimer Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No