Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2025-12-29 @ 9:25 PM
Study NCT ID:
NCT06619457
Status:
COMPLETED
Last Update Posted:
2025-04-03
First Post:
2024-09-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Anti-aging Efficacy of One Face Care Cosmetic Product
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C026423', 'term': '3,8-dihydroxy-6H-dibenzo(b,d)pyran-6-one'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-09-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-12-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-02', 'studyFirstSubmitDate': '2024-09-25', 'studyFirstSubmitQcDate': '2024-09-27', 'lastUpdatePostDateStruct': {'date': '2025-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anti-wrinkle efficacy', 'timeFrame': '12 weeks', 'description': 'Anti-wrinkle efficacy will be assessed in the periorbital regions wrinkles using AEVA. Parameters measured: Rz and Ra, representing mainly the rough structure (Rz) or the finer skin structure (Ra).'}, {'measure': 'Skin Biological age', 'timeFrame': '12-weeks', 'description': 'DNA methylation patterns analysis (epigenetics) by skin tape stripping (D-Squames)'}], 'secondaryOutcomes': [{'measure': 'Skin hydration', 'timeFrame': '12 weeks', 'description': 'Change from baseline in skin hydration (assessed on skin capacitance by Corneometer \\[a.u.\\])'}, {'measure': 'Transepidermal Water Loss (TEWL)', 'timeFrame': '12 weeks', 'description': 'Change from baseline in skin barrier function (assessed as transepidermal waterloss by Tewameter \\[g/(m²h)\\])'}, {'measure': 'Mitochondrial morphology in skin', 'timeFrame': '12 weeks', 'description': 'mitochondrial morphology in skin will be assessed via transmission electron microscopy (TEM) on 3mm punch-biopsies'}, {'measure': 'Photodocumentation of skin health', 'timeFrame': '12 weeks', 'description': 'ColorFace image analysis of face via facial photography'}, {'measure': 'Subjective questionnaire', 'timeFrame': '12 weeks', 'description': 'Subjective evaluation of product traits assessed via questionnaire'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mitochondria', 'Urolithin A', 'Mitopure', 'Aging'], 'conditions': ['Skin Aging']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the anti-wrinkle efficacy and effect on skin epigenetic and on mitochondrial morphology of a facial cosmetic product compared to a placebo'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written Informed Consent to participate in the study\n* Willingness to actively participate in the study and to come to the scheduled visits\n* Female and approximately 10% male (at least 4 male subjects)\n* From 50 to 75 years of age\n* Healthy skin in the test areas\n* Visible wrinkles in the face (grade 3 to 6 according to SGS proderm scale)\n\nFor biopsy subpanel:\n\n-Vaccination of tetanus within the last 10 years\n\nExclusion Criteria:\n\n* Female subjects: Pregnancy or lactation\n* Drug addicts, alcoholics\n* AIDS, HIV-positive or infectious hepatitis\n* Conditions which exclude a participation or might influence the test reaction/evaluation\n* Participation or being in the waiting period after participation in cosmetic and/or pharmaceutical studies pertaining to the test area\n* Active skin disease at the test area\n* Documented allergies to face/eye care products\n* Diabetes mellitus\n* Cancer not being diagnosed as cured and requiring chemotherapy, irradiation and/or hormonal treatment within the last 2 years\n* One of the following illnesses with reduced physical capability/fitness: asthma (symptom-free allergic asthma is not an exclusion criterion), hypertension (if not adjusted with medication), cardiovascular diseases\n* Epilepsy\n* Wounds, moles, tattoos, scars, irritated skin, excessive hair growth, freckles, etc. at the test area that could influence the investigation\n* Regular use of tanning beds\n* Any topical medication at the test area within the last 3 days prior to the start of the study\n* Systemic therapy with immuno-suppressive drugs (e.g. corticosteroids) and/or antihistamines (e.g. antiallergics) and/or within the last 7 days prior to the start of the study\n* Therapy with antibiotics within the last 2 weeks prior to the start of the study\n* Past cosmetic surgery procedure in the test area (e.g. laser, facelift)\n* Cosmetic surgery procedure in the test area, e.g. IPL (Intensed Pulsed Light), botox, chemical peel, dermabrasion within the last 2 years prior to the start of the study and/or throughout the entire course of the study\n* Medical treatment for wrinkle reduction (e.g. peeling with vitamin A or fruit acids) on the face within the last 2 weeks prior to the start of the study\n\nFor biopsy subpanel:\n\n* Regular medication with anti-coagulating drugs like Aspirin®, Macumar®, etc. (e.g. for thrombosis prophylaxis) within up to 15 days prior to the taking of the biopsies\n* History of complications at wound healing (e.g. keloids, hypertrophic scars or contracture scar)\n* Known intolerance to local anaesthetics\n* Known Sensitivity to any dressing systems'}, 'identificationModule': {'nctId': 'NCT06619457', 'acronym': 'SkinBioAge', 'briefTitle': 'Evaluation of the Anti-aging Efficacy of One Face Care Cosmetic Product', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amazentis SA'}, 'officialTitle': 'Evaluation of the Anti-aging Efficacy of One Face Care Cosmetic Product', 'orgStudyIdInfo': {'id': '24.0199-23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Placebo Cream', 'interventionNames': ['Other: Placebo Cream']}, {'type': 'EXPERIMENTAL', 'label': 'Active Moisturizing Cream', 'interventionNames': ['Other: Mitopure (Urolithin A) Cream']}], 'interventions': [{'name': 'Mitopure (Urolithin A) Cream', 'type': 'OTHER', 'description': 'cosmetic cream to be applied topically on face and forearms twice/daily using split/face design', 'armGroupLabels': ['Active Moisturizing Cream']}, {'name': 'Placebo Cream', 'type': 'OTHER', 'description': 'cosmetic cream to be applied topically on face and forearms twice/daily using split/face design', 'armGroupLabels': ['Placebo Cream']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22869', 'city': 'Schenefeld', 'state': 'Hamburg', 'country': 'Germany', 'facility': 'SGS proderm GmbH'}], 'overallOfficials': [{'name': 'Katrin Unbereit, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SGS proderm GmbH'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amazentis SA', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'proDERM GmbH', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}