Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2025-12-25 @ 7:45 PM
Study NCT ID:
NCT05805735
Status:
COMPLETED
Last Update Posted:
2023-09-06
First Post:
2023-03-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Anti-Wrinkle Efficacy Study of an Eye-Cream
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Blinding of sponsor label (de-branded product)'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Intra-individual comparison'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-04', 'studyFirstSubmitDate': '2023-03-28', 'studyFirstSubmitQcDate': '2023-03-28', 'lastUpdatePostDateStruct': {'date': '2023-09-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-30', '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': 'Dark circles color in difference by ColorFace image analysis Clinical assessment of dark circle reduction around the eye area by trained grader', 'timeFrame': '8-weeks'}, {'measure': 'Clinical assessment of dark circle reduction by trained grader', 'timeFrame': '8-weeks'}, {'measure': 'Subjective Evaluation of product traits assessed via questionnaire after 2, 4 and 8 weeks', 'timeFrame': '8-weeks'}, {'measure': 'Assessment of eye area puffiness by photo ranking by 3 trained graders', 'timeFrame': '8-weeks'}, {'measure': 'Photo documentation of skin by ColorFace', 'timeFrame': '8-weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Aging', 'Wrinkle']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the anti-aging and reduction of dark circles efficacy of a cosmetic product after 8 weeks of application.'}, '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 (approx. 10% male)\n* Between 40 and 65 years of age\n* Visible wrinkles in the periorbital regions in accordance with the study site's score of at least grade 3\n* Dark circles according to self-assessment (not guaranteed on darker skin types)\n* Healthy skin in the test areas\n* Uniform skin color and no erythema or dark pigmentation (except dark cycles are still visible) in the test area\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* 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* Insulin-dependent diabetes mellitus\n* Any topical medication at the test area within the last 7 days prior to the start of the study and/or throughout the entire course of the study\n* Documented allergies to face care or cleansing products\n* Active skin disease at the test area\n* Wounds, moles, tattoos, scars, irritated skin, excessive hair growth, etc. at the test area that could influence the investigation\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\n* Epilepsy\n* Obesity with a BMI \\> 40\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* 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': 'NCT05805735', 'briefTitle': 'Anti-Wrinkle Efficacy Study of an Eye-Cream', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amazentis SA'}, 'officialTitle': 'Anti-Wrinkle Efficacy Study', 'orgStudyIdInfo': {'id': '23.0076-27'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Face care product (Eye cream)', 'description': 'Comparison between assessment times. Assessments will be performed before, after 2, 4 and 8 weeks of product application.', 'interventionNames': ['Other: Face care product (Eye cream)']}], 'interventions': [{'name': 'Face care product (Eye cream)', 'type': 'OTHER', 'description': 'The test material(s) will be cosmetic products to be applied around the eye region on both sides of the face daily. The test product will be applied twice daily in the morning and in the evening by the subjects', 'armGroupLabels': ['Face care product (Eye cream)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Schenefeld', 'country': 'Germany', 'facility': 'proderm GmbH', 'geoPoint': {'lat': 54.04644, 'lon': 9.48146}}], 'overallOfficials': [{'name': 'Christiane Röck, Dipl. Biol', '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'}}}}