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A Cross-Sectional Natural History Study to Evaluate Sweat Volume and Other Phenotypic and Genetic Characteristics in Patients Affected by XLHED

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03912792
Recruitment Status : Withdrawn (Company decision)
First Posted : April 11, 2019
Last Update Posted : July 2, 2019
Sponsor:
Information provided by (Responsible Party):
Dermelix Biotherapeutics, LLC.

Study Description
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Brief Summary:

The proposed natural history study will enroll male patients with a diagnosis of XLHED, female carriers of XLHED and healthy volunteers. The study protocol will include collection of XLHED questionnaires and clinical outcomes using minimally invasive technologies. Data will be collected both retrospectively and prospectively.

Clinical outcome assessments will be performed at the NFED Family Conference on July 11-12, 2019. Study participants will be able to complete XLHED questionnaires electronically ahead of the conference.


Condition or disease
XLHED

Study Design
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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Other
Official Title: A Cross-Sectional Natural History Study to Evaluate Sweat Volume and Other Phenotypic and Genetic Characteristics in Patients Affected by X-Linked Hypohidrotic XLHED Ectodermal Dysplasia (XLHED)
Actual Study Start Date : June 28, 2019
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
XLHED Patients
Healthy Controls


Outcome Measures
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Primary Outcome Measures :
  1. The volume of sweat from a pilocarpine-induced sweat test [ Time Frame: Day 1 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   up to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Males with XLHED and female carriers of XLHED

Male and female healthy volunteers

Criteria

Inclusion Criteria:

  • Informed Consent
  • Males with XLHED, female carriers of XLHED and healthy volunteers

Exclusion Criteria:

  • Treatment with an investigational study drug for XLHED
  • Any major medical problems that would prevent her/him from participating in this study
  • Known hypersensitivity to pilocarpine or pilocarpine-like muscarinic agonists (Examples: Urecholine, Salagen, Pilocar, and Provocholine)
  • Pacemaker
Contacts and Locations
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Information from the National Library of Medicine

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): NCT03912792


Locations
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United States, Illinois
Chicago Marriott Lincolnshire Resort
Lincolnshire, Illinois, United States, 60069
Sponsors and Collaborators
Dermelix Biotherapeutics, LLC.
Investigators
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Principal Investigator: Dorothy K Grange, MD Washington University School of Medicine
More Information
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Responsible Party: Dermelix Biotherapeutics, LLC.
ClinicalTrials.gov Identifier: NCT03912792    
Other Study ID Numbers: DMX101-0001
First Posted: April 11, 2019    Key Record Dates
Last Update Posted: July 2, 2019
Last Verified: June 2019
Keywords provided by Dermelix Biotherapeutics, LLC.:
Natural History Study
X-Linked Hypohidrotic Ectodermal Dysplasia
Additional relevant MeSH terms:
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Ectodermal Dysplasia
Abnormalities, Multiple
Congenital Abnormalities
Skin Abnormalities
 Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases