Clinical Trials Logo

Clinical Trial Summary

The proposed natural history study will enroll male and female patients, ages 36 months and younger, who have a diagnosis of XLHED based on genetic testing and who have not received an investigational study drug. The study protocol will include collection of all relevant medical history and documentation of clinical outcomes using age-appropriate, minimally invasive technologies. Data will be collected both retrospectively, back to pregnancy assessments that may be available, and prospectively through age 5 yrs.


Clinical Trial Description

Important to the development and regulatory approval of therapies for XLHED will be the collection of data on the clinical history and prospective health of those affected by XLHED. The proposed natural history study will enroll male and female patients, ages 36 months and younger, who have a diagnosis of XLHED based on genetic testing and who have not received an investigational study drug. The study protocol will include collection of all relevant medical history and documentation of clinical outcomes using age-appropriate, minimally invasive technologies. Data will be collected both retrospectively, back to pregnancy assessments that may be available, and prospectively through age 5 yrs. Genotype-phenotype correlations in XLHED, based on well-documented health records and prospective assessments on genetically-confirmed individuals, may now provide new and clinically-predictive information for the benefit of patients, families, health care providers and clinical investigators designing trials for therapeutic interventions. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02099552
Study type Observational
Source Edimer Pharmaceuticals
Contact
Status Completed
Phase N/A
Start date April 2014
Completion date December 2016

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 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 NCT01342133 - Sweat Duct Imaging in Mother/Newborn Dyads N/A
Completed NCT01398397 - Medical Record Review of Hypohidrotic Ectodermal Dysplasia Clinical Phenotype N/A
Completed NCT01308333 - Investigation of Chronic Inflammatory Processes in Male Individuals With Hypohidrotic Ectodermal Dysplasia N/A
Completed NCT01135888 - Short Term Effects and Risks of Physical Exercise in Subjects With Hypohidrotic Ectodermal Dysplasia