Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2025-12-30 @ 2:00 PM
Study NCT ID:
NCT05473832
Status:
COMPLETED
Last Update Posted:
2023-04-06
First Post:
2022-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Anti-aging Efficacy of Four Skin Health Products
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 144}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2022-10-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-05', 'studyFirstSubmitDate': '2022-07-18', 'studyFirstSubmitQcDate': '2022-07-22', 'lastUpdatePostDateStruct': {'date': '2023-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anti-wrinkle efficacy will be assessed in the periorbital regions wrinkles using DermaTOP. Parameters measured: Rz and Ra, representing mainly the rough structure (Rz) or the finer skin structure (Ra).', 'timeFrame': '8-weeks'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in skin firmness by Cutometer [mm] after 2, 4 and 8 weeks', 'timeFrame': '8-weeks'}, {'measure': 'Change from baseline in skin elasticity by Cutometer after 2, 4 and 8 weeks', 'timeFrame': '8-weeks'}, {'measure': 'Change from baseline in skin hydration (assessed on skin capacitance by Corneometer [a.u.]) after 2, 4 and 8 weeks', 'timeFrame': '8-weeks'}, {'measure': 'Change from baseline in skin barrier function (assessed on transepidermal waterloss by Tewameter [g/(m²h)]) after 2, 4, 8-weeks', 'timeFrame': '8-weeks'}, {'measure': 'Change from baseline in ceramides by Raman Spectroscopy [a.u.] on a subgroup of n=12 subjects per test product group after 2, 4 and 8 weeks', 'timeFrame': '8-weeks'}, {'measure': 'Change in Image grading (Photodocumentation via USR-Clip) for skin radiance (3 trained graders will rank each pair of images in a blinded fashion) after 2, 4 and 8 weeks', 'timeFrame': '8-weeks'}, {'measure': "Change in wrinkle scores (Photodocumentation via USR-Clip) for anti-wrinkle efficacy (3 trained graders will rank each pair of images at the area of the crow feet's in a blinded manner)", 'timeFrame': '8-weeks'}, {'measure': 'Subjective Evaluation of product traits assessed via questionnaire after 2, 4 and 8 weeks', 'timeFrame': '8-weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anti-Aging', 'Skin Aging']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the anti-wrinkle and anti-aging efficacy of four different cosmetic products compared to an untreated control (split-face study design)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 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 male\n* From 40 to 65 years of age\n* BMI \\< 30 kg/m2\n* Healthy skin in the test areas\n* Uniform skin color and no erythema or dark pigmentation in the test area\n* Visible wrinkle in the face (grade 3 to 6 according to proderm scale) see Appendix 2\n* Ethnicity: at least one Black, Asian and Hispanic subject per study group\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 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* Sun-tanned skin (important for the subgroup of subjects planned for Raman measurements)\n* Regular use of tanning beds\n* Any topical medication at the test area within the last 7 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* 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'}, 'identificationModule': {'nctId': 'NCT05473832', 'briefTitle': 'Evaluation of the Anti-aging Efficacy of Four Skin Health Products', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amazentis SA'}, 'officialTitle': 'Evaluation of the Anti-aging Efficacy of Four Cosmetic Products', 'orgStudyIdInfo': {'id': '22.0229-39'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'interventionNames': ['Other: Day Cream cosmetic product compared to untreated side']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'interventionNames': ['Other: Night cream cosmetic product compared to untreated side']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3', 'interventionNames': ['Other: Eye cream cosmetic product compared to untreated side']}, {'type': 'EXPERIMENTAL', 'label': 'Group 4', 'interventionNames': ['Other: Serum cosmetic product compared to untreated side']}], 'interventions': [{'name': 'Day Cream cosmetic product compared to untreated side', 'type': 'OTHER', 'description': 'Applied once daily in the morning', 'armGroupLabels': ['Group 1']}, {'name': 'Night cream cosmetic product compared to untreated side', 'type': 'OTHER', 'description': 'Applied once daily in the evening', 'armGroupLabels': ['Group 2']}, {'name': 'Eye cream cosmetic product compared to untreated side', 'type': 'OTHER', 'description': 'Applied twice daily in the morning and in the evening around the eye area', 'armGroupLabels': ['Group 3']}, {'name': 'Serum cosmetic product compared to untreated side', 'type': 'OTHER', 'description': 'Applied twice daily in the morning and in the evening', 'armGroupLabels': ['Group 4']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Schenefeld', 'country': 'Germany', 'facility': 'proderm GmbH', 'geoPoint': {'lat': 54.04644, 'lon': 9.48146}}], 'overallOfficials': [{'name': 'Prof. Dr. med. Klaus-Peter Wilhelm, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'proDERM GmbH'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amazentis SA', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'proDERM GmbH', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}