A Cross-Sectional Natural History Study to Evaluate Sweat Volume and Other Phenotypic and Genetic Characteristics in Patients Affected by XLHED
Withdrawn
- Conditions
- XLHED
- Registration Number
- NCT03912792
- Lead Sponsor
- Dermelix Biotherapeutics, LLC.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The volume of sweat from a pilocarpine-induced sweat test Day 1
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Chicago Marriott Lincolnshire Resort
🇺🇸Lincolnshire, Illinois, United States