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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Edimer Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01398813
First received: July 19, 2011
Last updated: July 7, 2013
Last verified: July 2013
  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:


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
Study Completion Date: July 2013
Primary Completion Date: July 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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01398813

Locations
United States, Maine
Carrie Milliard
Portland, Maine, United States, 04103
Sponsors and Collaborators
Edimer Pharmaceuticals
Investigators
Principal Investigator: Carrie Milliard, CGC Maine Medical Partners Pediatric Specialty Care
  More Information

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: July 7, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Edimer Pharmaceuticals:
HED
XLHED

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

ClinicalTrials.gov processed this record on December 09, 2016