Ignite Creation Date:
2025-12-24 @ 4:45 PM
Ignite Modification Date:
2025-12-28 @ 11:01 AM
Study NCT ID:
NCT05537350
Status:
COMPLETED
Last Update Posted:
2022-09-13
First Post:
2022-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Study to Evaluate the Efficacy and Consumer Perception of Lumenato
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']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-11', 'studyFirstSubmitDate': '2022-05-11', 'studyFirstSubmitQcDate': '2022-09-11', 'lastUpdatePostDateStruct': {'date': '2022-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvment of skin barier as mesured by VapoMeter and FaceQ questionnaire', 'timeFrame': '12 weeks of use', 'description': 'VapoMeter Measurements before and after treatment FaceQ questionnaire before and after treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Skin']}, 'descriptionModule': {'briefSummary': "Subjects will be enrolled in this clinical study to assess the efficacy of an oral supplement to change the characteristics of facial skin after 4 and 12 weeks of use and obtain consumer perception of the test product through the use of questionnaires.\n\nStudy evaluations will include a comprehensive metabolic panel, Cutometer measurements, Canfield's VISIA-CR images, VapoMeter Measurements, and Consumer perception questionnaires."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subject is female between 35 and 55 years of age;\n2. Subject has a Fitzpatrick skin type of II, III, or IV;\n3. Subject is of Caucasian or Latino;\n4. Subject has self-perceived sensitive skin (defined as being sensitive to different topical products through different seasons resulting in any of the following: redness, irritation, itching, tingling, or edema);\n5. Subject to have a baseline TEWL of ≥12;\n6. Subject to have Glogau skin classification of Type 2 (see Appendix IV);\n7. Subject is willing to get their blood drawn at Baseline and Week 4;\n8. Subject is not currently enrolled in, and agrees not to participate in, any other oral nutritional supplement or face studies while enrolled in this study;\n9. Subject agrees not to introduce any new nutricosmetic, cosmetic or toiletry products during the study;\n10. Subject is dependable and able to follow directions as outlined in the protocol and anticipates being available for all study visits;\n11. Subject is willing to participate in all study evaluations;\n12. Subject is in generally good health and has a current Panelist Profile Form on file at CRL;\n13. Subject agrees to sign a Photography Release Form, providing consent for the capture of digital images for use in relation to this clinical study ;\n14. Subject has completed a HIPAA Authorization Form in conformance with 45 CFR Parts 160 and 164;\n15. Subject understands and is willing to sign an Informed Consent Form in conformance with 21 CFR Part 50: "Protection of Human Subjects."\n\nExclusion Criteria:\n\n1. Subject is pregnant, nursing, planning a pregnancy, or not using adequate birth control;\n2. Subject has a history of digestive problems;\n3. Subject is on blood thinners;\n4. Subject has received treatment with sympathomimetics, antihistamines, vasoconstrictors, non-steroidal anti-inflammatory agents, and/or systemic or topical corticosteroids within 4 week prior to initiation of the study;\n5. Chronic or relapsing inflammatory and/or allergic skin conditions such as atopic dermatitis, rosacea, psoriasis and alike including telangiectasias ("spider veins");\n6. Current diagnosis of adult acne or currently on treatment for adult acne;\n7. Participants who have received facial irradiation within last year or are planning on undergoing facial irradiation during the study;\n8. Participants who currently take supplements containing carotenoids, lutein, melatonin or tryptophan;\n9. Participants who use tanning salons or tanning products in the last 3 months;\n10. Participants who plan to undergo invasive facial procedures (injections, chemical peeling, etc.) during the study or have undergone these procedures within 2 months prior to enrollment;\n11. Participants with auto-immune skin diseases (e.g. scleroderma, psoriasis, lupus, epidermolysis bullosa, bullous pemphigoid, temporal arteritis);\n12. Participants who have been prescribed retinoids treatment (\\<2 months prior to enrollment);\n13. Current smokers;\n14. Subject has a history of acute or chronic dermatologic, medical, and/or physical conditions which would, in the opinion of the Principal Investigator, preclude application of the test material and/or could influence the outcome of the study;\n15. Subject is currently taking certain medications which, in the opinion of the Principal Investigator, may interfere with the study;\n16. Subject is not willing to participate in all study evaluations;\n17. Subject has known allergies to skin treatment products or cosmetics, toiletries, nutraceuticals, nutricosmetic, and/or topical drugs;\n18. Subject has a history of skin cancer, or is currently undergoing treatment for active cancer of any kind;\n19. Subject has diabetes.'}, 'identificationModule': {'nctId': 'NCT05537350', 'briefTitle': 'A Clinical Study to Evaluate the Efficacy and Consumer Perception of Lumenato', 'organization': {'class': 'INDUSTRY', 'fullName': 'LycoRed Ltd.'}, 'officialTitle': 'A 12 Weeks of Clinical Study to Evaluate the Efficacy and Consumer Perception of Different Skin Attributes Following Supplementation of an Oral Supplement- Lumenato', 'orgStudyIdInfo': {'id': 'CRLNJ2021-0990 BI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lumenato', 'description': '1 Lumenato soft gel once a day', 'interventionNames': ['Dietary Supplement: Lumenato']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '1 Soft gels without active ingredients once a day', 'interventionNames': ['Dietary Supplement: Lumenato']}], 'interventions': [{'name': 'Lumenato', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Supplementation of 12 weeks', 'armGroupLabels': ['Lumenato', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08854', 'city': 'Piscataway', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Eurofins | CRL, Inc.', 'geoPoint': {'lat': 40.49927, 'lon': -74.39904}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LycoRed Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}