Sweat Duct Imaging in Mother/Newborn Dyads

Edimer Pharmaceuticals28 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

X-Linked Hypohidrotic Ectodermal Dysplasia

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Washington University School of Medicine

St Louis, Missouri, United States

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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