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NCT01109290 Clinical Trial

Characterization of Sweat Gland Function in Patients With Recessively Inherited Hypohidrotic Ectodermal Dysplasia

Hypohidrotic Ectodermal Dysplasia Clinical Trial

Official title:
Validation of Non-invasive Technologies for the Characterization of Sweat Gland Function in Patients With Recessively Inherited Hypohidrotic Ectodermal Dysplasia, Their Heterozygous Family Members and Healthy Controls

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01109290
Other study ID # ED10
Secondary ID
Status Completed
Phase N/A
First received April 21, 2010
Last updated September 13, 2011
Start date April 2010
Est. completion date June 2011

Study information
Verified date September 2011
Source University Hospital Erlangen
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

Clinical Trial Summary

Hypohidrotic ectodermal dysplasia (HED) is a complex genetic disorder characterized by lack of sweat glands, sparse hair, and missing or malformed teeth. Inability to sweat may result in episodes of severe hyperthermia and cause sudden infant death. To assess sweat gland function in HED patients, the investigators will first quantify gland pores in a defined area of the palm and then stimulate the glands by pilocarpine followed by sweat collection in a special capillary for volume determination. This will be combined with non-invasive skin conductance measurement prior and subsequent to stimulation of the sympathetic nervous system. The data should provide a basis for genotype-phenotype correlation.

Recruitment information / eligibility
Status Completed
Enrollment 65
Est. completion date June 2011
Est. primary completion date August 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A to 60 Years
Eligibility Inclusion Criteria:

- for patients: hypohidrotic ectodermal dysplasia caused by mutations in the genes EDA or EDAR

- written informed consent

Exclusion Criteria:

- febrile disease

- pregnancy or breastfeeding

- implantable electronic devices, e.g. pacemaker

- hypersensitivity to self-adhesive electrodes

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Germany University Hospital Erlangen Erlangen Bavaria

Sponsors (2)
Lead Sponsor Collaborator
University Hospital Erlangen Edimer Pharmaceuticals

Country where clinical trial is conducted

Germany, 

See also
  Status Clinical Trial Phase
Completed NCT01629927 - Evaluation of Phenotypic and Genetic Properties in Male Subjects Affected By Hypohidrotic Ectodermal Dysplasia (ECP-012) N/A
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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 NCT01386775 - Male Subjects Affected By Hypohidrotic Ectodermal Dysplasia: Intrafamilial Variation N/A
Completed NCT05378932 - Impact of Dysregulation of Core Body Temperature on Sleep in Patients With Hypohidrotic Ectodermal Dysplasia N/A
Completed NCT01398813 - X-Linked Hypohidrotic Ectodermal Dysplasia (XLHED) Carrier Outlook Toward Reproduction Survey N/A
Completed NCT01293565 - Evaluation of Phenotypic and Genetic Properties in Male Subjects Affected by Hypohidrotic Ectodermal Dysplasia - A N/A
Completed NCT01398397 - Medical Record Review of Hypohidrotic Ectodermal Dysplasia Clinical Phenotype N/A