Sweat Duct Imaging in Mother/Newborn Dyads

Completed

• Conditions: X-Linked Hypohidrotic Ectodermal Dysplasia

• Registration Number: NCT01342133
• Lead Sponsor: Edimer Pharmaceuticals

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.

Study Timeline

• Study Start: 2011-04
• Primary Completion: 2011-04
• Study First Submitted: 2011-04-22
• Study First Submitted QC: 2011-04-25
• Study First Posted: 2011-04-27
• Study Completion: 2011-07
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-26
• Last Update Posted: 2012-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 St. Louis, Missouri, United States