Sweat Duct Imaging in Mother/Newborn Dyads

Edimer Pharmaceuticals

Status: Completed

Conditions: X-Linked Hypohidrotic Ectodermal Dysplasia

Study type: Observational

Funder types: Industry

Identifiers

NCT01342133

ECP-005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

28 participants in 2 patient groups

Newborns

Mothers