Natural History and Outcomes in X-Linked Hypohidrotic Ectodermal Dysplasia
Completed
Conditions studied: X-Linked Hypohidrotic Ectodermal Dysplasia
In brief
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.
Key facts
- Study ID
- NCT02099552
- Run by
- Edimer Pharmaceuticals
- People needed
- 150
- Starts
- 2014-04-01
- Expected to finish
- 2016-12-01
- Last updated by the study team
- 2017-09-05
Who can join
Age: any, up to 3. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subjects must meet all of the following criteria to be enrolled in this study:
- Confirmed genetic diagnosis of XLHED
- Written informed consent of both parents (if reasonably available)
You may not qualify if…
- Subjects who meet any of the following criteria cannot be enrolled in this study:
- Medically-significant complications or congenital anomalies outside of those considered to be associated with the diagnosis or status of XLHED
- Having received an investigational study drug prior to enrollment. For subjects less than 6 months of age, the mother cannot have taken an investigational drug during her pregnancy.
- Known hypersensitivity to pilocarpine or pilocarpine-like muscarinic agonists
- Presence of pacemakers
Where it is running
- University of California, San Francisco — San Francisco, California, United States
- Children's National Medical Center — Washington D.C., District of Columbia, United States
- Washington University School of Medicine — St Louis, Missouri, United States
- Hôpital Necker-Enfants Malades — Paris, France
- University Hospital Erlangen — Erlangen, Bavaria, Germany
- Azienda Ospedaliera-Polo Universitario "Luigi Sacco" — Milan, Italy
- University Hospital of Wales — Cardiff, United Kingdom
Full record on ClinicalTrials.gov
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