Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2025-12-25 @ 11:11 PM
Study NCT ID:
NCT06174493
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-12
First Post:
2023-12-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Investigating Participation Patterns of Patients in Atopic Dermatitis Clinical Trials
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-12-08', 'size': 76902, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-12-08T10:02', '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': '2023-12-08', 'studyFirstSubmitQcDate': '2023-12-08', 'lastUpdatePostDateStruct': {'date': '2024-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of atopic dermatitis patients who decide to enroll in a clinical research', 'timeFrame': '3 months'}, {'measure': 'Rate of atopic dermatitis patients who remain in clinical trial to trial completion', 'timeFrame': '12 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['atopic dermatitis'], 'conditions': ['Atopic Dermatitis']}, 'referencesModule': {'references': [{'pmid': '31679111', 'type': 'BACKGROUND', 'citation': 'Shalom G, Kridin K, Raviv KO, Freud T, Comaneshter D, Friedland R, Cohen AD, Ben-Amitai D. Atopic Dermatitis and Celiac Disease: A Cross-Sectional Study of 116,816 Patients. Am J Clin Dermatol. 2020 Feb;21(1):133-138. doi: 10.1007/s40257-019-00474-2.'}, {'pmid': '35041211', 'type': 'BACKGROUND', 'citation': 'Schut C, Dalgard FJ, Bewley A, Evers AWM, Gieler U, Lien L, Sampogna F, Stander S, Tomas-Aragones L, Vulink N, Finlay AY, Legat FJ, Titeca G, Jemec GB, Misery L, Szabo C, Grivcheva-Panovska V, Spillekom-van Koulil S, Balieva F, Szepietowski JC, Reich A, Roque Ferreira B, Lvov A, Romanov D, Marron SE, Gracia-Cazana T, Svensson A, Altunay IK, Thompson AR, Zeidler C, Kupfer J; ESDAP Study collaborators. Body dysmorphia in common skin diseases: results of an observational, cross-sectional multicentre study among dermatological outpatients in 17 European countries. Br J Dermatol. 2022 Jul;187(1):115-125. doi: 10.1111/bjd.21021. Epub 2022 May 22.'}, {'pmid': '33725337', 'type': 'BACKGROUND', 'citation': 'Patruno C, Fabbrocini G, Longo G, Argenziano G, Ferrucci SM, Stingeni L, Peris K, Ortoncelli M, Offidani A, Amoruso GF, Talamonti M, Girolomoni G, Grieco T, Iannone M, Nettis E, Foti C, Rongioletti F, Corazza M, Veneri MD, Napolitano M; Dupilumab for Atopic Dermatitis of the Elderly (DADE) Study Group. Effectiveness and Safety of Long-Term Dupilumab Treatment in Elderly Patients with Atopic Dermatitis: A Multicenter Real-Life Observational Study. Am J Clin Dermatol. 2021 Jul;22(4):581-586. doi: 10.1007/s40257-021-00597-5.'}]}, 'descriptionModule': {'briefSummary': 'Clinical trials, specifically focused on atopic dermatitis, are crucial in assessing the safety and efficacy of new treatments. These trials serve as fundamental instruments in determining whether emerging medications outperform standard therapies, providing compelling evidence to support wider implementation.\n\nThe main goal is to thoroughly scrutinize trial completion rates and voluntary withdrawals among this particular group of patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with atopic dermatitis 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* Ability to understand and the willingness to sign a written informed consent document\n* Participant must be 18 years of age or older\n* Confirmed diagnosis of atopic dermatitis\n\nExclusion Criteria:\n\n* Enrolled in another research study\n* Is pregnant, breastfeeding or expecting to conceive within the projected duration of the study\n* Inability to provide written informed consent'}, 'identificationModule': {'nctId': 'NCT06174493', 'briefTitle': 'Investigating Participation Patterns of Patients in Atopic Dermatitis Clinical Trials', 'organization': {'class': 'INDUSTRY', 'fullName': 'Power Life Sciences Inc.'}, 'officialTitle': 'Understanding Patient Engagement Trends in Atopic Dermatitis Clinical Research', 'orgStudyIdInfo': {'id': '66783591'}}, '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'}}}}