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

This study is currently recruiting participants.
Verified August 2012 by Edimer Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Edimer Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01398813
First received: July 19, 2011
Last updated: August 20, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition
Hypohidrotic Ectodermal Dysplasia
X-Linked Hypohidrotic Ectodermal Dysplasia

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Survey of X-Linked Hypohidrotic Ectodermal Dysplasia Carrier Women's Outlook Towards Reproduction, Potential XLHED Treatments and Genetic Testing

Resource links provided by NLM:

MedlinePlus related topics: Genetic Testing
U.S. FDA Resources

Further study details as provided by Edimer Pharmaceuticals:

Primary Outcome Measures:
  • To study the outlook of XLHED carrier females toward reproduction, potential XLHED treatments and genetic testing. [ Time Frame: study day 1 ] [ Designated as safety issue: No ]
    Survey results will be collected during the 1 day of subject involvement.


Estimated Enrollment: 500
Study Start Date: July 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Detailed 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The study will enroll XLHED carrier females

Criteria

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;
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01398813

Contacts
Contact: Carrie Milliard, MS, CGC 207-662-6712

Locations
United States, Maine
Carrie Milliard Recruiting
Portland, Maine, United States, 04103
Contact: Carrie Milliard, MS, CGC     207-662-6712     MILLIC@mmc.org    
Sponsors and Collaborators
Edimer Pharmaceuticals
Investigators
Principal Investigator: Carrie Milliard, CGC Maine Medical Partners Pediatric Specialty Care
  More Information

No publications provided

Responsible Party: Edimer Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01398813     History of Changes
Other Study ID Numbers: ECP-008
Study First Received: July 19, 2011
Last Updated: August 20, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Edimer Pharmaceuticals:
HED
XLHED

Additional relevant MeSH terms:
Ectodermal Dysplasia
Ectodermal Dysplasia 1, Anhidrotic
Hyperplasia
Abnormalities, Multiple
Congenital Abnormalities
Skin Abnormalities
 Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases
Genetic Diseases, X-Linked
Pathologic Processes

ClinicalTrials.gov processed this record on May 22, 2013