Sweat Duct Imaging in Mother/Newborn Dyads

NCT ID: NCT01342133

Last Updated: 2012-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

28 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-04-30

Study Completion Date

2011-07-31

Brief Summary

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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

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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.

Conditions

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X-Linked Hypohidrotic Ectodermal Dysplasia

Study Groups

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Newborns

No interventions assigned to this group

Mothers

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Edimer Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lisa Moscoso, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Dorothy K Grange, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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ECP-005

Identifier Type: -

Identifier Source: org_study_id

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