Sweat Duct Imaging in Mother/Newborn Dyads

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Edimer Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01342133
First received: April 22, 2011
Last updated: June 26, 2012
Last verified: June 2012
  Purpose

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
X-Linked Hypohidrotic Ectodermal Dysplasia

Study Type: Observational
Official Title: Sweat Duct Imaging in Mother/Newborn Dyads

Resource links provided by NLM:


Further study details as provided by Edimer Pharmaceuticals:

Primary Outcome Measures:
  • Demonstrate the use of a confocal microscope to quantify sweat ducts on the plantar surface of healthy, term newborns [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    These measurements will be used as comparison data in subsequent trials involving those affected by X-Linked Hypohidrotic Ectodermal Dysplasia.


Enrollment: 28
Study Start Date: April 2011
Study Completion Date: July 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Newborns
Mothers

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.

  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01342133

Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Edimer Pharmaceuticals
Investigators
Principal Investigator: Lisa Moscoso, MD, PhD Washington University School of Medicine
Principal Investigator: Dorothy K Grange, MD Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Edimer Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01342133     History of Changes
Other Study ID Numbers: ECP-005
Study First Received: April 22, 2011
Last Updated: June 26, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Ectodermal Dysplasia
Ectodermal Dysplasia 1, Anhidrotic
Abnormalities, Multiple
Congenital Abnormalities
Skin Abnormalities
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases
Genetic Diseases, X-Linked

ClinicalTrials.gov processed this record on October 16, 2014