Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-30 @ 1:44 PM
Study NCT ID:
NCT05004103
Status:
UNKNOWN
Last Update Posted:
2021-08-13
First Post:
2021-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cosmetic Products and Facial Skin Microbiome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Pre-post study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-03-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-08-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-12', 'studyFirstSubmitDate': '2021-07-08', 'studyFirstSubmitQcDate': '2021-08-12', 'lastUpdatePostDateStruct': {'date': '2021-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Microbiome diversity index', 'timeFrame': '28 days', 'description': 'The amount and diversity of microbiota will be observed on facial skin before and after product application'}, {'measure': 'Facial skin elasticity', 'timeFrame': '28 days', 'description': 'The ratio between pliability/firmness and expressed in mm. The result before and after product application will be observed by cutometer.'}, {'measure': 'Sebum unit of facial skin', 'timeFrame': '28 days', 'description': 'Sebumeter unit (mcg/cm2) of facial skin before and after product application will be observed using sebumeter. This sebumeter unit reflects the concentration of sebum on skin per observed area.'}, {'measure': 'Capacity of corneometer unit', 'timeFrame': '28 days', 'description': 'Corneometer unit reflects the moist index of skin. The corneometer unit observed by Corneometer, before and after product application.'}, {'measure': 'Skin color intensity', 'timeFrame': '28 dyas', 'description': 'The skin color expressed in colorimeter index value. The observation is conducted before and after product application'}, {'measure': 'Transepidermal Waterloss (g/h/m2)', 'timeFrame': '28 days', 'description': 'The hydration of skin is observed by Tewameter. The observation is conducted before and after product application'}, {'measure': 'pH of facial skin', 'timeFrame': '28 days', 'description': 'The pH of facial skin is observed using skin-pH-meter. Observation is conducted before and after product application'}, {'measure': 'The skin color related to the Minimal Erythema Dosage (MED)', 'timeFrame': '28 Days', 'description': 'The skin color (MED) is observed using Mexameter and is conducted before and after product application'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Skin Microbiome', 'Facial Skin Microbiome', 'MIcrobiome diversity'], 'conditions': ['Cosmetics Product Effects']}, 'referencesModule': {'references': [{'pmid': '22954074', 'type': 'BACKGROUND', 'citation': 'Collins-Fulea C, Klima K, Wegienka GR. Prevalence of low vitamin D levels in an urban midwestern obstetric practice. J Midwifery Womens Health. 2012 Sep-Oct;57(5):439-44. doi: 10.1111/j.1542-2011.2012.00167.x.'}, {'pmid': '28761849', 'type': 'BACKGROUND', 'citation': 'Vijay A, Gupta S, Rawat S, Jain SK. A Rare Case of Coinfection with White Piedra and Pediculosis Capitis. Indian Dermatol Online J. 2017 Jul-Aug;8(4):279-280. doi: 10.4103/idoj.IDOJ_353_16. No abstract available.'}, {'type': 'BACKGROUND', 'citation': 'Wallen-Russell, C. The Role of Every-Day Cosmetics in Altering the Skin Microbiome: A Study Using Biodiversity. Cosmetics 2019, 6, 2. https://doi.org/10.3390/cosmetics6010002'}, {'pmid': '29332945', 'type': 'RESULT', 'citation': 'Byrd AL, Belkaid Y, Segre JA. The human skin microbiome. Nat Rev Microbiol. 2018 Mar;16(3):143-155. doi: 10.1038/nrmicro.2017.157. Epub 2018 Jan 15.'}, {'pmid': '30333815', 'type': 'RESULT', 'citation': 'Ogai K, Nagase S, Mukai K, Iuchi T, Mori Y, Matsue M, Sugitani K, Sugama J, Okamoto S. A Comparison of Techniques for Collecting Skin Microbiome Samples: Swabbing Versus Tape-Stripping. Front Microbiol. 2018 Oct 2;9:2362. doi: 10.3389/fmicb.2018.02362. eCollection 2018.'}, {'pmid': '29193830', 'type': 'RESULT', 'citation': 'Lee HJ, Jeong SE, Lee S, Kim S, Han H, Jeon CO. Effects of cosmetics on the skin microbiome of facial cheeks with different hydration levels. Microbiologyopen. 2018 Apr;7(2):e00557. doi: 10.1002/mbo3.557. Epub 2017 Nov 29.'}]}, 'descriptionModule': {'briefSummary': 'The skin microbiome diversity in female healthy volunteers will be studied along with cosmetic products application in 1 month period. This study is also aimed to investigate the efficacy of cosmetic products on skin rejuvenation. .', 'detailedDescription': "The study is conducted in COVID-19 pandemic era, thus every person involved in this study must follow health protocol for COVID-19.\n\nThe study procedure, consist of screening visit (D -7), 7-day wash out, baseline visit (D 0), first follow up ( D 14), and second follow up (D 28).\n\n1. Screening visit: obtained Informed Consent, COVID-19 detection by swab RT-PCR, and inclusion and exclusion criteria, wash out product dispensing, and subject's diary dispensing.\n2. Baseline visit: Investigator will check vital signs, facial skin value by Cutometer, Mexameter, Sebumeter, Corneometer, Colorimeter, Tewameter, dan pH meter, and kin taping by Corneofix tape. Investigational Products will dispensed in this visit for 2 weeks usage.\n3. First follow up: Investigator will check vital signs and facial skin value. Investigational Products will dispensed in this visit for 2 weeks usage.\n4. Second follow up: Investigator will check vital signs, facial skin value, and skin taping by Corneofix tape.\n\nAll adverse events (AEs) occurred during study will be recorded in Case Report Form."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Healthy females', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. female 18-35 years old\n2. signed the informed consent\n\nExclusion Criteria:\n\n1. infected by COVID-19\n2. females with skin diseases on face and neck such as atopic dermatitis, skin allergy, acne with moderate and severe degree, seborrheic dermatitis, malignancy\n3. females with ongoing skin treatments.'}, 'identificationModule': {'nctId': 'NCT05004103', 'briefTitle': 'Cosmetic Products and Facial Skin Microbiome', 'organization': {'class': 'OTHER', 'fullName': 'Indonesia University'}, 'officialTitle': 'The Efficacy of Cosmetic Products and Its Effects on Facial Skin Microbiome', 'orgStudyIdInfo': {'id': 'CRSU.P.PTI/11/20/17.02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Skin microbiome evaluation', 'description': 'Female healthy volunteers applied cosmetic products (cleanser and moisturizer cream), the diversity of skin microbiome will be examined before and after using the products', 'interventionNames': ['Other: Cosmetic products application']}], 'interventions': [{'name': 'Cosmetic products application', 'type': 'OTHER', 'description': 'Female healthy volunteers applied cosmetic products (cleanser and moisturizer) in the morning and afternoon for 1 month. Seven days wash out period will be conducted prior study starts. The evaluation will be conducted before, two weeks after treatment starts, and at the end of the study.', 'armGroupLabels': ['Skin microbiome evaluation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10430', 'city': 'Jakarta Pusat', 'state': 'DKI Jakarta', 'country': 'Indonesia', 'facility': 'Clinical Research Supporting Unit', 'geoPoint': {'lat': -6.1818, 'lon': 106.8223}}], 'overallOfficials': [{'name': 'Frans Suyatna, Prof, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Research Supporting Unit, Faculty of Medicine, University of Indonesia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indonesia University', 'class': 'OTHER'}, 'collaborators': [{'name': 'PT Paragon Technology and Innovation', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Pharmacology Professor', 'investigatorFullName': 'Prof. dr. Franciscus D. Suyatna, PhD, SpFK', 'investigatorAffiliation': 'Indonesia University'}}}}