Sweat Duct Imaging in Mother/Newborn Dyads

X-Linked Hypohidrotic Ectodermal Dysplasia Clinical Trial

Official title:

Sweat Duct Imaging in Mother/Newborn Dyads

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01342133
• Other study ID #: ECP-005
• Status: Completed
• Phase: N/A
• First received: April 22, 2011
• Last updated: June 26, 2012
• Start date: April 2011
• Est. completion date: July 2011

Study information

• Verified date: June 2012
• Source: Edimer Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: July 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

N/A

Related Conditions & MeSH terms

• Ectodermal Dysplasia
• X-Linked Hypohidrotic Ectodermal Dysplasia

Locations

Country	Name	City	State
United States	Washington University School of Medicine	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Edimer Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 1	No
Primary	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.	Day 1	No