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NCT01398397 Clinical Trial

Medical Record Review of Hypohidrotic Ectodermal Dysplasia Clinical Phenotype

X-Linked Hypohidrotic Ectodermal Dysplasia Clinical Trial

— ECP-006  

Official title:
Medical Record Review of Hypohidrotic Ectodermal Dysplasia Clinical Phenotype

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01398397
Other study ID # ECP-006
Secondary ID
Status Completed
Phase N/A
First received July 19, 2011
Last updated June 26, 2012
Start date April 2011

Study information
Verified date June 2012
Source Edimer Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

This study is being done to collect information about people who have or may have Hypohidrotic Ectodermal Dysplasia (HED) or X-linked Hypohidrotic Ectodermal Dysplasia (XLHED). This study will allow Edimer Pharmaceuticals to know more about HED/XLHED so that hopefully the investigators can develop a drug to treat this condition. In this study Edimer will retrospectively review and abstract (summarize) medical records of people that have or may have HED/XLHED in order to further understand the natural history and disease characteristics.

Recruitment information / eligibility
Status Completed
Enrollment 11
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

-Males or females with:

1. the clinical characteristics of HED, including at least two of the following characteristics: 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.

-OR-

2. genetically confirmed HED or XLHED;

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Edimer Pharmaceuticals Cambridge Massachusetts

Sponsors (2)
Lead Sponsor Collaborator
Edimer Pharmaceuticals National Foundation of Ectodermal Dysplasia

Country where clinical trial is conducted

United States, 

See also
  Status Clinical Trial Phase
Completed NCT01564225 - A Phase 1, Open-label, Multicenter, Safety and Pharmacokinetic Study of EDI200 Phase 1
Active, not recruiting NCT01992289 - Extension Study of XLHED-Affected Male Subjects Treated With EDI200 in Protocol ECP-002 N/A
Completed NCT01629927 - Evaluation of Phenotypic and Genetic Properties in Male Subjects Affected By Hypohidrotic Ectodermal Dysplasia (ECP-012) N/A
Completed NCT01629940 - Phenotypic and Genetic Properties in Males at Risk for X-linked Hypohidrotic Ectodermal Dysplasia: Evaluation of an Early Diagnosis Technology and Tests to Assess Nutritional Status N/A
Completed NCT01398813 - X-Linked Hypohidrotic Ectodermal Dysplasia (XLHED) Carrier Outlook Toward Reproduction Survey N/A
Completed NCT02099552 - Natural History and Outcomes in X-Linked Hypohidrotic Ectodermal Dysplasia N/A
Completed NCT01775462 - Phase 2 Study to Evaluate Safety, Pharmacokinetics, Immunogenicity and Pharmacodynamics/Efficacy of EDI200 in Male Infants With X-Linked Hypohidrotic Ectodermal Dysplasia (XLHED) Phase 2
Completed NCT01308333 - Investigation of Chronic Inflammatory Processes in Male Individuals With Hypohidrotic Ectodermal Dysplasia N/A
Completed NCT01342133 - Sweat Duct Imaging in Mother/Newborn Dyads N/A
Completed NCT01135888 - Short Term Effects and Risks of Physical Exercise in Subjects With Hypohidrotic Ectodermal Dysplasia