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Sweat Duct Imaging in Mother/Newborn Dyads

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ClinicalTrials.gov Identifier: NCT01342133
Recruitment Status : Completed
First Posted : April 27, 2011
Last Update Posted : June 28, 2012
Sponsor:
Information provided by (Responsible Party):
Edimer Pharmaceuticals

Study Description
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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.

Condition or disease
X-Linked Hypohidrotic Ectodermal Dysplasia

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 Design
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Study Type : Observational
Actual Enrollment : 28 participants
Official Title: Sweat Duct Imaging in Mother/Newborn Dyads
Study Start Date : April 2011
Actual Primary Completion Date : April 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sweat

Groups and Cohorts
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Group/Cohort
Newborns
Mothers


Outcome Measures
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Primary Outcome Measures :
  1. Demonstrate the use of a confocal microscope to quantify sweat ducts on the plantar surface of healthy, term newborns [ Time Frame: 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.

  2. 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 [ Time Frame: Day 1 ]
    These measurements will be used as comparison data in subsequent trials involving those affected by X-Linked Hypohidrotic Ectodermal Dysplasia.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01342133


Locations
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United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Edimer Pharmaceuticals
Investigators
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Principal Investigator: Lisa Moscoso, MD, PhD Washington University School of Medicine
Principal Investigator: Dorothy K Grange, MD Washington University School of Medicine
More Information
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Responsible Party: Edimer Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01342133    
Other Study ID Numbers: ECP-005
First Posted: April 27, 2011    Key Record Dates
Last Update Posted: June 28, 2012
Last Verified: June 2012
Additional relevant MeSH terms:
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Ectodermal Dysplasia
Ectodermal Dysplasia 1, Anhidrotic
Abnormalities, Multiple
Congenital Abnormalities
Skin Abnormalities
 Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases
Genetic Diseases, X-Linked