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

XLHED Clinical Trial

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03912792
• Other study ID #: DMX101-0001
• Status: Withdrawn
• Start date: June 28, 2019
• Est. completion date: September 2019

Study information

• Verified date: June 2019
• Source: Dermelix Biotherapeutics, LLC.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Ectodermal Dysplasia
• XLHED

Locations

Country	Name	City	State
United States	Chicago Marriott Lincolnshire Resort	Lincolnshire	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Dermelix Biotherapeutics, LLC.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The volume of sweat from a pilocarpine-induced sweat test		Day 1