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Investigation of Chronic Inflammatory Processes in Male Individuals With Hypohidrotic Ectodermal Dysplasia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01308333
First Posted: March 4, 2011
Last Update Posted: January 8, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Edimer Pharmaceuticals
Information provided by (Responsible Party):
Prof. Dr. Holm Schneider, University Hospital Erlangen
March 3, 2011
March 4, 2011
January 8, 2014
April 2011
November 2011   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01308333 on ClinicalTrials.gov Archive Site
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Investigation of Chronic Inflammatory Processes in Male Individuals With Hypohidrotic Ectodermal Dysplasia
Investigation of Chronic Inflammatory Processes in the Respiratory Tract and the Eyes of Male Individuals With X-linked Hypohidrotic Ectodermal Dysplasia
X-linked hypohidrotic ectodermal dysplasia (XLHED) is a complex genetic disorder characterized by lack of sweat, sebaceous, submucous, Meibomian and mammary glands, sparse hair and eyebrows, and oligodontia. Insufficient function of the respective glands may lead to chronic inflammatory processes in airways and eyes of the affected individuals. The investigators will quantify sweat glands of XLHED patients, assess chronic conjunctivitis and blepharitis in conjunction with quantitative and/or qualitative alterations of lacrimal fluid in these subjects, evaluate lung function and assess chronic inflammatory processes in the airways by NO measurements. The data should provide a basis for genotype-phenotype correlations.
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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples Without DNA
Description:
tear fluid
Non-Probability Sample
subjects with X-linked hypohidrotic ectodermal dysplasia (XLHED) and healthy controls
X-linked Hypohidrotic Ectodermal Dysplasia
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  • XLHED children
  • XLHED adults
  • Control children
  • Control adults
Dietz J, Kaercher T, Schneider AT, Zimmermann T, Huttner K, Johnson R, Schneider H. Early respiratory and ocular involvement in X-linked hypohidrotic ectodermal dysplasia. Eur J Pediatr. 2013 Aug;172(8):1023-31. doi: 10.1007/s00431-013-1985-8. Epub 2013 Apr 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
38
November 2011
November 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • for patients: X-linked hypohidrotic ectodermal dysplasia caused by mutations in the gene EDA
  • written informed consent

Exclusion Criteria:

  • acute respiratory disease
  • acute allergic problem, e.g. allergic coryza
  • implantable electronic devices, e.g. pacemaker
Sexes Eligible for Study: Male
6 Years to 60 Years   (Child, Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01308333
ED11
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Prof. Dr. Holm Schneider, University Hospital Erlangen
University Hospital Erlangen
Edimer Pharmaceuticals
Principal Investigator: Holm Schneider, MD University Hospital Erlangen
University Hospital Erlangen
January 2014