Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2025-12-26 @ 1:34 AM
Study NCT ID:
NCT06143033
Status:
COMPLETED
Last Update Posted:
2024-02-22
First Post:
2023-11-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Clinical Trial to Evaluate the Effects of an Eye Serum on Improving the Appearance of the Periorbital Area
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'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-20', 'studyFirstSubmitDate': '2023-11-05', 'studyFirstSubmitQcDate': '2023-11-19', 'lastUpdatePostDateStruct': {'date': '2024-02-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in appearance of periorbital puffiness. [Baseline to Day 60]', 'timeFrame': '60 days', 'description': 'Measured via expert skin grading of before \\& after photos conducted by a board-certified dermatologist.'}, {'measure': 'Change in appearance of dark circles underneath eyes. [Baseline to Day 60]', 'timeFrame': '60 days', 'description': 'Measured via expert skin grading of before \\& after photos conducted by a board-certified dermatologist.'}, {'measure': "Change in participants' perception of the appearance of periorbital puffiness. [Baseline to Day 60]", 'timeFrame': '60 days', 'description': 'Measured via study-specific surveys. Surveys will be completed by participants and are designed using a 5-point Likert scale, with th 5 representing the most favorable/best outcome (e.g., "Not at all") and 1 representing the least favorable/worst outcome (e.g., "Severe").'}, {'measure': "Change in participants' perception of the appearance of dark circles underneath eyes. [Baseline to Day 60]", 'timeFrame': '60 days', 'description': 'Measured via study-specific surveys. Surveys will be completed by participants and are designed using a 5-point Likert scale, with th 5 representing the most favorable/best outcome (e.g., "Not at all") and 1 representing the least favorable/worst outcome (e.g., "Severe").'}], 'secondaryOutcomes': [{'measure': 'Change in appearance of fine lines and wrinkles in the eye area. [Baseline to Day 60]', 'timeFrame': '60 days', 'description': 'Measured via expert skin grading of before \\& after photos conducted by a board-certified dermatologist.'}, {'measure': "Change in participants' perception of the appearance of fine lines and wrinkles in the eye area. [Baseline to Day 60]", 'timeFrame': '60 days', 'description': 'Measured via study-specific surveys. Surveys will be completed by participants and are designed using a 5-point Likert scale, with th 5 representing the most favorable/best outcome (e.g., "Not at all") and 1 representing the least favorable/worst outcome (e.g., "Severe").'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Periorbital Area']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the efficacy of the DIME Beauty Luminosity Eye Serum in improving the appearance of skin in the periorbital eye area. This study will last for 60 days. The study will be conducted as a single-arm trial in which all participants will use the test products. Participants will be required to complete questionnaires at Baseline, Day 30, and Day 60, photos will be taken at Baseline, Day 30, and Day 60, and expert skin grading will take place at Baseline and Day 60.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Females age 18-65.\n* Have visible dark circles under the eyes.\n* Have puffy eyes.\n* Have bags under the eyes.\n* Have visible fine lines and wrinkles around the eyes.\n* Have a smartphone or camera to take before-and-after selfies.\n\nExclusion Criteria:\n\n* Anyone not in good health.\n* Anyone who has any chronic health conditions such as oncological or psychiatric disorders.\n* Anyone who has any known serious allergic reactions that require the use of an Epi-Pen.\n* Anyone who is pregnant, breastfeeding, or wanting to become pregnant over the next three months.\n* Anyone who cannot/ will not commit to the study protocol.\n* Anyone with a history of substance abuse.'}, 'identificationModule': {'nctId': 'NCT06143033', 'briefTitle': 'A Clinical Trial to Evaluate the Effects of an Eye Serum on Improving the Appearance of the Periorbital Area', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dime Beauty Co.'}, 'officialTitle': 'A Clinical Trial to Evaluate the Effects of an Eye Serum on Improving the Appearance of the Periorbital Area', 'orgStudyIdInfo': {'id': '20363'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DIME Beauty Luminosity Eye Serum', 'description': 'Participants will use the serum twice daily after their morning and evening skincare routine (i.e., after cleansing, and applying facial serums and moisturizers), but before the application of sunscreen.', 'interventionNames': ['Other: DIME Beauty Luminosity Eye Serum']}], 'interventions': [{'name': 'DIME Beauty Luminosity Eye Serum', 'type': 'OTHER', 'description': 'Test product contains: Water/Aqua, Organic Aloe Vera Juice, Lycium Barbarum (Goji Berry) Fruit Extract, Vitis Vinifera (Grape Seed) Extract, Cucumis Sativus (Cucumber) Extract, Glycerin, Niacinamide, Squalane, Camellia Seed Oil, DL-Panthenol (Vitamin B5), Carbomer, Sodium Hyaluronate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Phenoxyethenol, Caprylyl Glycol, Acacia Senegal Gum, Caffeine, Helianthus Annuus (Sunflower) Seed Oil, Malus Domestica (Apple) Fruit Stem Cell Extract, Argania Spinosa (Argan) Sprout Stem Cell Extract, Tetrahexyldecyl Ascorbate (Vitamin C), Acetyl Tetrapeptide, Acetyl Hexapeptide-8, Vitamin E Mixed Tocopherols, Sodium Hydroxide.', 'armGroupLabels': ['DIME Beauty Luminosity Eye Serum']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Citruslabs', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dime Beauty Co.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Citruslabs', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}