Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2025-12-25 @ 3:16 AM
Study NCT ID:
NCT06189105
Status:
RECRUITING
Last Update Posted:
2024-01-03
First Post:
2023-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety Assessment of Niacinamide Cosmetic Preparation: a Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017495', 'term': 'Hyperpigmentation'}, {'id': 'D004485', 'term': 'Eczema'}], 'ancestors': [{'id': 'D010859', 'term': 'Pigmentation Disorders'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-18', 'studyFirstSubmitDate': '2023-09-13', 'studyFirstSubmitQcDate': '2023-12-18', 'lastUpdatePostDateStruct': {'date': '2024-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'TEWL assessment with Courage Khazaka probe', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Transepidermal water loss'}, {'measure': 'Hydration assessment with corneometer probe', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'stratum corneum hydration'}, {'measure': 'pigmentation assessment with mexameter probe', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'erythema and melanin'}, {'measure': 'skin oiliness assessment with sebumeter probe', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'sebum level'}], 'secondaryOutcomes': [{'measure': 'subjective opinion of participants', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'participants notes on skin rection'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Skin Hyperpigmentation', 'Dry Skin; Eczema']}, 'referencesModule': {'references': [{'pmid': '39768384', 'type': 'DERIVED', 'citation': 'Rusic D, Ivic M, Slugan A, Leskur D, Modun D, Durdov T, Vukovic D, Bukic J, Bozic J, Seselja Perisin A. Pilot Study on the Effects of a Cosmetic Serum Containing Niacinamide, Postbiotics and Peptides on Facial Skin in Healthy Participants: A Randomized Controlled Trial. Life (Basel). 2024 Dec 18;14(12):1677. doi: 10.3390/life14121677.'}]}, 'descriptionModule': {'briefSummary': 'Niacinamide in lower concentrations has been recognized as a cosmetic ingredient with hydrating properties. Therefore, aim was to test the efficacy and safety of niacinamide cosmetic preparation in A Randomized, Controlled Trial.', 'detailedDescription': 'Skin hydration (as use of hydrating cosmetic ingredients) is one of the most interventions for healthy skin and skin barrier function. Therefore, cosmetic ingredients used for this purpose should be examined for their efficacy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy volunteers who gave written informed consent\n\nExclusion Criteria:\n\n* skin disease, skin damage on measurement sites, use of corticosteroids and immunomodulators a month prior to the inclusion and during the trial, non-adherence to the trial protocol, exposure to artificial UV radiation, pregnancy and lactation'}, 'identificationModule': {'nctId': 'NCT06189105', 'briefTitle': 'Efficacy and Safety Assessment of Niacinamide Cosmetic Preparation: a Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of Split, School of Medicine'}, 'officialTitle': 'Testing the Efficacy and Safety of Niacinamide Cosmetic Preparation: A Randomised, Controlled Trial', 'orgStudyIdInfo': {'id': '2181-198-03-04-23-032'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'experimental arm', 'description': 'Use of facial serum with\n\nniacinamide, plant-based collagen and\n\npeptides on randomized site on forehead', 'interventionNames': ['Other: miss alice face it you love me serum']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo comparator', 'description': 'No treatment (usual\n\nskincare rutine)', 'interventionNames': ['Other: No treatment (usual skincare rutine)']}], 'interventions': [{'name': 'miss alice face it you love me serum', 'type': 'OTHER', 'description': 'Facial serum with niacinamide, plant-based collagen and peptides will be applied by each participant to the treatment site according to randomization protocol every evening', 'armGroupLabels': ['experimental arm']}, {'name': 'No treatment (usual skincare rutine)', 'type': 'OTHER', 'description': 'No treatment (usual skincare rutine)', 'armGroupLabels': ['placebo comparator']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Split', 'status': 'RECRUITING', 'country': 'Croatia', 'contacts': [{'name': 'Josipa Bukic', 'role': 'CONTACT', 'email': 'jbukic@mefst.hr', 'phone': '00385917933752'}], 'facility': 'University of Split School of Medicine', 'geoPoint': {'lat': 43.50891, 'lon': 16.43915}}], 'centralContacts': [{'name': 'Josipa Bukic', 'role': 'CONTACT', 'email': 'jbukic@mefst.hr', 'phone': '00385917933752'}], 'overallOfficials': [{'name': 'Dario Leskur', 'role': 'STUDY_DIRECTOR', 'affiliation': 'USSM'}]}, 'ipdSharingStatementModule': {'infoTypes': ['CSR'], 'timeFrame': 'upon request', 'ipdSharing': 'YES', 'description': 'upon request', 'accessCriteria': 'upon request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Split, School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant professor', 'investigatorFullName': 'Dario Leskur', 'investigatorAffiliation': 'University of Split, School of Medicine'}}}}