X-Linked Hypohidrotic Ectodermal Dysplasia
Conditions
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Edimer Pharmaceuticals
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* Healthy term newborns (37-42 weeks gestation at delivery) in the Assessment Nursery at Barnes-Jewish Hospital, St. Louis, MO * Mother of a healthy term newborn who is enrolled in this study
Exclusion criteria
* Congenital abnormalities affecting skin, nails, or hair in the newborn infant * Family history of a sweating disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Demonstrate the use of a confocal microscope to quantify sweat ducts on the plantar surface of healthy, term newborns | Day 1 | 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. |
| 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 | Day 1 | These measurements will be used as comparison data in subsequent trials involving those affected by X-Linked Hypohidrotic Ectodermal Dysplasia. |
Countries
United States
Outcome results
None listed