Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2025-12-26 @ 2:49 AM
Study NCT ID:
NCT06083402
Status:
COMPLETED
Last Update Posted:
2023-10-16
First Post:
2023-08-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of a Dietary Supplement on Parameters of Skin Aging in Men and Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Neither the participants nor the investigators will know the group assignment. Supplements will be prepared by the sponsor and marked with unidentifiable ID numbers before being sent to study site.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Healthy men and women with mild to moderate signs of skin aging will be randomly assigned to either receive a Ritual HyaCera or placebo for 12 weeks'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-10-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-11', 'studyFirstSubmitDate': '2023-08-16', 'studyFirstSubmitQcDate': '2023-10-11', 'lastUpdatePostDateStruct': {'date': '2023-10-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Dermatologist grading of skin condition', 'timeFrame': 'at week 0, Week 4, Week 8, and Week 12', 'description': "Visual and tactile dermatologist evaluation of skin condition (fine lines in the crow's feet area, wrinkles in the crow's feet area, skin dryness, skin radiance, and skin smoothness) based on 10-point grading scale (with 0 being no signs of aging and 9 being the most severe)"}, {'measure': 'Self-evaluation of perceived changes in skin condition', 'timeFrame': 'at week 0, Week 4, Week 8, and Week 12', 'description': 'Self-evaluation of changes in skin condition and signs of skin aging (i.e. fine lines \\& wrinkles, skin texture, skin smoothness, skin plumpness, skin glow/radiance, skin hydration, skin elasticity, skin redness, skin itchiness) using a 5-point Likert scale (options: much worse, somewhat worse, stayed the same, somewhat better, much better)'}], 'primaryOutcomes': [{'measure': "Crow's Feet Wrinkles", 'timeFrame': 'at week 0, Week 4, Week 8, and Week 12', 'description': "Degree of crow's feet wrinkling will be measured via Visioscan®"}, {'measure': 'Skin Smoothness', 'timeFrame': 'at week 0, Week 4, Week 8, and Week 12', 'description': 'Skin smoothness will be measured via Visioscan®'}, {'measure': 'Skin Hydration', 'timeFrame': 'at week 0, Week 4, Week 8, and Week 12', 'description': 'Skin surface hydration will be measured via Corneometer® 825'}], 'secondaryOutcomes': [{'measure': 'Skin Elasticity', 'timeFrame': 'at week 0, Week 4, Week 8, and Week 12', 'description': 'Skin elasticity will be measured via Cutometer® MPA 580'}, {'measure': 'Skin Barrier Function', 'timeFrame': 'at week 0, Week 4, Week 8, and Week 12', 'description': 'Skin barrier function (as transepidermal water loss) will be measured via Tewameter®'}, {'measure': 'Skin Scaliness', 'timeFrame': 'at week 0, Week 4, Week 8, and Week 12', 'description': 'Skin scaliness will be measured via Visioscan®'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['skin aging', 'skin wrinkles', 'skin hydration', 'skin elasticity', 'skin firmness', 'skin smoothness', "crow's feet wrinkles", 'dietary supplement', 'skin barrier function'], 'conditions': ['Skin Aging']}, 'referencesModule': {'references': [{'pmid': '41071523', 'type': 'DERIVED', 'citation': 'Grier-Welch AM, Vance AY, Alamdari N, Sharafi M. Efficacy of an Oral Skincare Supplement on Skin Aging: A 12-Week Randomized, Double-Blind, Placebo-Controlled Trial. Dermatol Ther (Heidelb). 2025 Dec;15(12):3689-3702. doi: 10.1007/s13555-025-01556-2. Epub 2025 Oct 10.'}]}, 'descriptionModule': {'briefSummary': "As the body ages, the skin experiences natural changes in structure and composition. These changes may manifest visibly as increased skin dryness, wrinkling, and a loss of firmness/elasticity. In this double-blind, randomized, placebo-controlled trial, the investigators will recruit healthy men and women with mild to moderate signs of skin aging and randomly assign them to either receive a HyaCera™ or placebo for 12 weeks. The investigators will perform a series of objective and subjective measurements to assess changes in skin condition. The investigators hypothesize that consumption of HyaCera™ leads to improvements in the general condition of the skin including skin hydration, crow's feet wrinkling, and other skin aging parameters."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male and female volunteers, 25 - 70 years old with mild to moderate fine lines and wrinkles\n* All ethnicities and skin types\n* Willing to maintain current skincare regimen on face, arms, and legs and withhold all facial and body treatments throughout the course of the study\n\nExclusion Criteria:\n\n* Self-reported pregnant or breastfeeding or planning to become pregnant during the course of the study\n* Any conditions on the face, arms and legs that would interfere with evaluations\n* Under treatment for any known health issues/medical conditions including chronic health conditions and skin diseases/conditions'}, 'identificationModule': {'nctId': 'NCT06083402', 'briefTitle': 'Efficacy of a Dietary Supplement on Parameters of Skin Aging in Men and Women', 'organization': {'class': 'INDUSTRY', 'fullName': 'Natals, Inc. dba Ritual'}, 'officialTitle': 'Evaluating the Efficacy of a Dietary Supplement on Parameters of Skin Aging: a 12-Week, Randomized, Double-Blind, Placebo-Controlled Study', 'orgStudyIdInfo': {'id': 'HyaCera2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active', 'description': 'Participants receive 1 HyaCera™ capsule orally once daily for 12 weeks', 'interventionNames': ['Dietary Supplement: HyaCera™']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants receive 1 placebo capsule orally once daily for 12 weeks', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'HyaCera™', 'type': 'DIETARY_SUPPLEMENT', 'description': '1 Ritual HyaCera capsule once daily', 'armGroupLabels': ['Active']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': '1 placebo capsule once daily', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08869', 'city': 'Raritan', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Princeton Consumer Research', 'geoPoint': {'lat': 40.56955, 'lon': -74.63294}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Natals, Inc. dba Ritual', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}