WithdrawnNot Applicable

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

Stopped: Company decision

United States0Started 2019-06-28

Plain-language 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.

Who can participate

Age range80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

The volume of sweat from a pilocarpine-induced sweat test

Timeframe: Day 1

Trial details

NCT IDNCT03912792

SponsorDermelix Biotherapeutics, LLC.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2019-09

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