Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 1:17 AM
Study NCT ID:
NCT07323303
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-07
First Post:
2025-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Real-World Study on the Burden of Hidradenitis Suppurativa
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017497', 'term': 'Hidradenitis Suppurativa'}], 'ancestors': [{'id': 'D017192', 'term': 'Skin Diseases, Bacterial'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D013492', 'term': 'Suppuration'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D016575', 'term': 'Hidradenitis'}, {'id': 'D013543', 'term': 'Sweat Gland Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-22', 'studyFirstSubmitDate': '2025-12-22', 'studyFirstSubmitQcDate': '2025-12-22', 'lastUpdatePostDateStruct': {'date': '2026-01-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To estimate work productivity loss in patients with HS.', 'timeFrame': 'At recruitment', 'description': 'Using the Work Productivity and Activity Impairment (WPAI) questionnaire. This questionnaire provides a quantitative measure of impairment over the last 7 days and includes four metrics: absenteeism (work time missed because of health issues during the past 7 days), presenteeism (impairment while working due to health issues during the past 7 days), overall work productivity loss (combination of absenteeism and presenteeism), and activity impairment.'}], 'secondaryOutcomes': [{'measure': 'To estimate the QoL of patients with HS', 'timeFrame': 'At recruitment', 'description': 'The Hidradenitis Suppurativa Quality of Life Questionnaire (HiSQOL) is a validated, HS-specific instrument designed to capture the multidimensional impact of HS on quality of life over the previous 7 days. It consists of 17 items that use Likert-type response options, ranging from 0 ("not at all") to 4 ("extremely"), with some items allowing respondents to indicate that an activity was not performed due either to lack of relevance or HS severity'}, {'measure': 'To estimate pain intensity in patients with HS.', 'timeFrame': 'At recruitment', 'description': 'Patients with HS will self-report the worst intensity of their pain over the past 7 days using an 11-point numeric rating scale (NRS). The NRS ranges from 0 ("No Pain") to 10 ("The worst imaginable Pain"). Pain was selected as a key symptom given its substantial impact on patients\' daily lives and QoL. The 7-day recall period was chosen to balance recall accuracy and symptom variability, capturing recent disease activity while minimizing recall bias.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hidradenitis Suppurativa (HS)']}, 'descriptionModule': {'briefSummary': "Despite the significant impact of HS on patients' quality of life (QoL) and daily functioning, there remains limited real-world evidence describing the burden of this condition in Canada. HS is an under-recognized and often misdiagnosed condition, with a substantial psychological and physical burden on patients. Understanding the real-world experiences of individuals living with HS in Canada can help identify unmet needs and inform patient-centered care approaches."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with HS', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient diagnosed with HS;\n2. Aged ≥18 years;\n3. Able to read and understand French or English;\n4. Willing and able to provide written informed consent.\n\nExclusion Criteria:\n\n1\\. Participation in an interventional study for HS.'}, 'identificationModule': {'nctId': 'NCT07323303', 'briefTitle': 'Real-World Study on the Burden of Hidradenitis Suppurativa', 'organization': {'class': 'OTHER', 'fullName': 'PeriPharm'}, 'officialTitle': 'Real-World Study on the Burden of Hidradenitis Suppurativa', 'orgStudyIdInfo': {'id': 'PROxy85HS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patient with HS', 'description': 'Patient diagnosed with HS', 'interventionNames': ['Other: No Intervention: Observational Cohort']}], 'interventions': [{'name': 'No Intervention: Observational Cohort', 'type': 'OTHER', 'description': 'No specific intervention is assess in this study. Observational cohort.', 'armGroupLabels': ['Patient with HS']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jean Lachaine, PhD', 'role': 'CONTACT', 'email': 'jean.lachaine@peripharm.com', 'phone': '514-731-8207'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PeriPharm', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}