Ignite Creation Date:
2025-12-25 @ 12:20 AM
Ignite Modification Date:
2025-12-25 @ 10:23 PM
Study NCT ID:
NCT06201858
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-12
First Post:
2023-12-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Journey Into Participation Patterns Among Patients With Hidradenitis Suppurativa
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-12-29', 'size': 76174, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-12-29T07:13', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-09', 'studyFirstSubmitDate': '2023-12-29', 'studyFirstSubmitQcDate': '2023-12-29', 'lastUpdatePostDateStruct': {'date': '2024-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of hidradenitis suppurativa patients who decide to enroll in a clinical research', 'timeFrame': '3 months'}, {'measure': 'Rate of hidradenitis suppurativa patients who remain in clinical trial to trial completion', 'timeFrame': '12 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hidradenitis Suppurativa'], 'conditions': ['Hidradenitis Suppurativa']}, 'referencesModule': {'references': [{'pmid': '29183082', 'type': 'BACKGROUND', 'citation': 'Saunte DML, Jemec GBE. Hidradenitis Suppurativa: Advances in Diagnosis and Treatment. JAMA. 2017 Nov 28;318(20):2019-2032. doi: 10.1001/jama.2017.16691.'}, {'pmid': '34615396', 'type': 'BACKGROUND', 'citation': 'Garcovich S, Fania L, Caposiena D, Giovanardi G, Chiricozzi A, De Simone C, Tartaglia C, Ciccone D, Bianchi L, Abeni D, Peris K. Pediatric Hidradenitis Suppurativa: A Cross-Sectional Study on Clinical Features and Treatment Approaches. J Cutan Med Surg. 2022 Mar-Apr;26(2):127-134. doi: 10.1177/12034754211039993. Epub 2021 Oct 6.'}, {'pmid': '34037678', 'type': 'BACKGROUND', 'citation': "Jfri A, Nassim D, O'Brien E, Gulliver W, Nikolakis G, Zouboulis CC. Prevalence of Hidradenitis Suppurativa: A Systematic Review and Meta-regression Analysis. JAMA Dermatol. 2021 Aug 1;157(8):924-931. doi: 10.1001/jamadermatol.2021.1677."}]}, 'descriptionModule': {'briefSummary': 'This study aims to uncover the factors driving patient decisions regarding enrollment, withdrawal, or re-engagement in hidradenitis suppurativa clinical trials. Understanding these factors will significantly improve the relevance and effectiveness of future research endeavors.\n\nUltimately, this trial endeavors to deepen our understanding of the factors impacting hidradenitis suppurativa clinical trial participation. Enhancing participation rates could accelerate the development of innovative treatments for this debilitating condition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with hidradenitis suppurativa who are actively considering enrolling in a clinical study for said condition, but have not yet completed enrollment and randomization.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged ≥ 18 years old\n* Diagnosis of hidradenitis suppurativa\n* Able to comprehend the investigational nature of the protocol and provide informed consent\n\nExclusion Criteria:\n\n* Female patients who are currently pregnant or nursing\n* Inability to perform regular electronic reporting\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.'}, 'identificationModule': {'nctId': 'NCT06201858', 'briefTitle': 'A Journey Into Participation Patterns Among Patients With Hidradenitis Suppurativa', 'organization': {'class': 'INDUSTRY', 'fullName': 'Power Life Sciences Inc.'}, 'officialTitle': 'Examining Engagement Trends Among Participants in Hidradenitis Suppurativa Clinical Trials', 'orgStudyIdInfo': {'id': '67172350'}}, 'contactsLocationsModule': {'locations': [{'zip': '94107', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'Michael B Gill', 'role': 'CONTACT', 'email': 'https://www.withpower.com/contact-us@withpower.com', 'phone': '415-900-4227'}], 'facility': 'Power Life Sciences', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'centralContacts': [{'name': 'Michael B Gill', 'role': 'CONTACT', 'email': 'bask@withpower.com', 'phone': '415-900-4227'}], 'overallOfficials': [{'name': 'Michael B Gill', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Power Life Sciences Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Power Life Sciences Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}