An observational study in X-Linked Hypohidrotic Ectodermal Dysplasia, sponsored by Edimer Pharmaceuticals. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2012-06-28.
Sponsored by Edimer Pharmaceuticals · Observational
The purpose of this study is to evaluate sweat duct number on the plantar surface of newborn infants using a non-invasive confocal microscopy device.
In this exploratory study, the investigators propose to evaluate sweat duct number on the plantar surface of newborn infants using a non-invasive confocal microscopy device (Lucid Vivascope®). This approach has the potential to be valuable in repeated sweat endpoint assessments, as the device was selected based on its ease of use, the low risk to patients of all ages, and its ability to generate quantitative data.
20 studies on the registry are indexed under Ectodermal Dysplasia 1, Anhidrotic; 1 is open to participants now.
This study's enrollment of 28 is below the median of 33 across 16 observational studies indexed under Ectodermal Dysplasia 1, Anhidrotic.
Browse Ectodermal Dysplasia 1, Anhidrotic studies →Edimer Pharmaceuticals is the lead sponsor of 13 studies on the registry; none are open to participants now.
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The study will enroll up to twenty healthy term newborns and their mothers in the Assessment Nursery at Barnes-Jewish Hospital.
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Demonstrate the use of a confocal microscope to quantify sweat ducts on the plantar surface of healthy, term newborns
To demonstrate the ease of use of a non-invasive confocal imaging device in the evaluation and measurement of sweat ducts on the plantar surface of healthy, term newborns. These measurements will be used as comparison data in subsequent trials involving those affected by X-Linked Hypohidrotic Ectodermal Dysplasia.
Time frame: Day 1
To assess the sweat duct density (i.e. the number of sweat ducts) in a 6 x 6 mm area on the plantar surface of healthy, term newborns, males and females, and the palmar surface of their mothers
These measurements will be used as comparison data in subsequent trials involving those affected by X-Linked Hypohidrotic Ectodermal Dysplasia.
Time frame: Day 1
This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.
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Ectodermal Dysplasia 1, Anhidrotic →
Edimer Pharmaceuticals