Sweat Duct Imaging in Mother/Newborn Dyads

NCT01342133 | Completed

• 1 other identifier: ECP-005
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

X-Linked Hypohidrotic Ectodermal Dysplasia

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Newborns

Mothers

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will enroll up to twenty healthy term newborns and their mothers in the Assessment Nursery at Barnes-Jewish Hospital.

You may qualify if:

• 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

You may not qualify if:

• Congenital abnormalities affecting skin, nails, or hair in the newborn infant
• Family history of a sweating disorder

Sponsors & Collaborators

• Edimer Pharmaceuticals: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Ectodermal Dysplasia 1, Anhidrotic

Condition Hierarchy (Ancestors)

Ectodermal Dysplasia; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Abnormalities; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Skin Diseases, Genetic; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Lisa Moscoso, MD, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

• Dorothy K Grange, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2011
• First Posted: April 27, 2011
• Study Start: April 1, 2011
• Primary Completion: April 1, 2011
• Study Completion: July 1, 2011
• Last Updated: June 28, 2012

Record last verified: 2012-06

Locations

US (1)