Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2025-12-27 @ 1:24 PM
Study NCT ID:
NCT03912792
Status:
WITHDRAWN
Last Update Posted:
2019-07-02
First Post:
2019-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Cross-Sectional Natural History Study to Evaluate Sweat Volume and Other Phenotypic and Genetic Characteristics in Patients Affected by XLHED
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053358', 'term': 'Ectodermal Dysplasia 1, Anhidrotic'}], 'ancestors': [{'id': 'D004476', 'term': 'Ectodermal Dysplasia'}, {'id': 'D000015', 'term': 'Abnormalities, Multiple'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D012868', 'term': 'Skin Abnormalities'}, {'id': 'D040181', 'term': 'Genetic Diseases, X-Linked'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Company decision', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-06-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2019-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-06-28', 'studyFirstSubmitDate': '2019-04-10', 'studyFirstSubmitQcDate': '2019-04-10', 'lastUpdatePostDateStruct': {'date': '2019-07-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The volume of sweat from a pilocarpine-induced sweat test', 'timeFrame': 'Day 1'}]}, 'conditionsModule': {'keywords': ['Natural History Study', 'X-Linked Hypohidrotic Ectodermal Dysplasia'], 'conditions': ['XLHED']}, 'descriptionModule': {'briefSummary': '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.\n\nClinical 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Males with XLHED and female carriers of XLHED\n\nMale and female healthy volunteers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed Consent\n* Males with XLHED, female carriers of XLHED and healthy volunteers\n\nExclusion Criteria:\n\n* Treatment with an investigational study drug for XLHED\n* Any major medical problems that would prevent her/him from participating in this study\n* Known hypersensitivity to pilocarpine or pilocarpine-like muscarinic agonists (Examples: Urecholine, Salagen, Pilocar, and Provocholine)\n* Pacemaker'}, 'identificationModule': {'nctId': 'NCT03912792', 'briefTitle': 'A Cross-Sectional Natural History Study to Evaluate Sweat Volume and Other Phenotypic and Genetic Characteristics in Patients Affected by XLHED', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dermelix Biotherapeutics, LLC.'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'DMX101-0001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'XLHED Patients'}, {'label': 'Healthy Controls'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60069', 'city': 'Lincolnshire', 'state': 'Illinois', 'country': 'United States', 'facility': 'Chicago Marriott Lincolnshire Resort', 'geoPoint': {'lat': 42.19002, 'lon': -87.9084}}], 'overallOfficials': [{'name': 'Dorothy K Grange, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dermelix Biotherapeutics, LLC.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}