Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2025-12-26 @ 3:38 AM
Study NCT ID:
NCT05738018
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-06-12
First Post:
2023-02-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluating Patient Experiences in Skin Care Clinical Studies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-02-10', 'size': 76744, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-02-10T05:28', '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': '2024-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-09', 'studyFirstSubmitDate': '2023-02-10', 'studyFirstSubmitQcDate': '2023-02-10', 'lastUpdatePostDateStruct': {'date': '2023-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of patients who decide to enroll in a skin care clinical study.', 'timeFrame': '3 months'}, {'measure': 'Number of skin care study participants who remain in clinical trial until completion.', 'timeFrame': '12 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Skin Care'], 'conditions': ['Skin Care']}, 'referencesModule': {'references': [{'pmid': '31945604', 'type': 'BACKGROUND', 'citation': 'Lichterfeld-Kottner A, El Genedy M, Lahmann N, Blume-Peytavi U, Buscher A, Kottner J. Maintaining skin integrity in the aged: A systematic review. Int J Nurs Stud. 2020 Mar;103:103509. doi: 10.1016/j.ijnurstu.2019.103509. Epub 2019 Dec 23.'}, {'pmid': '26165590', 'type': 'BACKGROUND', 'citation': 'Lichterfeld A, Hauss A, Surber C, Peters T, Blume-Peytavi U, Kottner J. Evidence-Based Skin Care: A Systematic Literature Review and the Development of a Basic Skin Care Algorithm. J Wound Ostomy Continence Nurs. 2015 Sep-Oct;42(5):501-24. doi: 10.1097/WON.0000000000000162.'}, {'pmid': '25159337', 'type': 'BACKGROUND', 'citation': 'Kottner J, Boronat X, Blume-Peytavi U, Lahmann N, Suhr R. The epidemiology of skin care provided by nurses at home: a multicentre prevalence study. J Adv Nurs. 2015 Mar;71(3):570-80. doi: 10.1111/jan.12517. Epub 2014 Aug 27.'}]}, 'descriptionModule': {'briefSummary': 'Enrollment in clinical trials usually favors a particular demographic group. But there is limited research available to explain what study attributes affect the completion of these specific demographic groups.\n\nThis trial will evaluate the safety and efficacy of new skin care products and treatments. The focus will be on tracking the rates of completion and withdrawal among these individuals.\n\nIt will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future skin care studies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who are actively considering involvement in an observational skin care clinical trial, but have not yet completed enrollment and registration.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is at least 18 years of age\n* Patient is able and willing to comply with the treatment/follow-up schedule and requirements\n* Patient must provide written informed consent\n\nExclusion Criteria:\n\n* Women who are pregnant, intend to become pregnant, or are lactating\n* Inability to perform regular electronic reporting\n* Participants who are vulnerable to any intervention'}, 'identificationModule': {'nctId': 'NCT05738018', 'briefTitle': 'Evaluating Patient Experiences in Skin Care Clinical Studies', 'organization': {'class': 'INDUSTRY', 'fullName': 'Power Life Sciences Inc.'}, 'officialTitle': 'An Observational Study Analyzing Patient Experiences in Skin Care Clinical Trials', 'orgStudyIdInfo': {'id': '80190623'}}, 'contactsLocationsModule': {'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'}}}}