Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-26 @ 3:16 AM
Study NCT ID:
NCT03460860
Status:
COMPLETED
Last Update Posted:
2019-06-26
First Post:
2018-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Astaxanthin (2 mg) + Lycopene (1.8 mg) + D-Alpha-Tocopherol (10 IU) For The Treatment Of Skin Aging
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C005948', 'term': 'astaxanthine'}, {'id': 'D000077276', 'term': 'Lycopene'}, {'id': 'D024502', 'term': 'alpha-Tocopherol'}], 'ancestors': [{'id': 'D002338', 'term': 'Carotenoids'}, {'id': 'D011090', 'term': 'Polyenes'}, {'id': 'D000475', 'term': 'Alkenes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D053138', 'term': 'Cyclohexenes'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D010860', 'term': 'Pigments, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D024505', 'term': 'Tocopherols'}, {'id': 'D014810', 'term': 'Vitamin E'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2019-02-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-24', 'studyFirstSubmitDate': '2018-03-04', 'studyFirstSubmitQcDate': '2018-03-04', 'lastUpdatePostDateStruct': {'date': '2019-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Proportion of subjects within each treatment group with a significant decrease in skin wrinkling measured by a validated Crow's Feet Wrinkle scale.", 'timeFrame': '12 weeks', 'description': 'The scale ratings are 0 for no wrinkles, 1 for very fine wrinkles, 2 for fine wrinkles, 3 for moderate wrinkles, and 4 for severe wrinkles.'}], 'secondaryOutcomes': [{'measure': 'Proportion of subjects within each treatment group with a significant increase in skin hydration measured by a corneometer.', 'timeFrame': '12 weeks'}, {'measure': 'Proportion of subjects within each treatment group with a significant decrease in pigmentation measured by a mexameter.', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Skin Aging', 'Wrinkles']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the clinical efficacy of a combination of Astaxanthin (2 mg), Lycopene (1.8 mg), and d-alpha-Tocopherol (10 IU) in terms of its skin anti-aging properties. Specifically, the investigators aim to determine the increase in hydration levels of the skin, decrease in atypical skin pigmentation, and reduction of signs of photoaging, particularly facial fine lines.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy individuals age 30 to 60 years old\n* Fitzpatrick Skin Type I-IV\n* Crow's Feet Wrinkle Scale Class 1-2\n* Subjects willing to provide written informed consent\n\nExclusion Criteria:\n\n* Use of topical or oral anti-aging drug therapy 1 month prior to the study\n* History of allergy to cosmetics and anti-aging drugs\n* History of photosensitivity reactions\n* Any current or past medical condition, including seizures and stroke\n* History of pigmentation disorder such as but not limited to vitiligo and leukoderma\n* Immunocompromised state\n* Pregnant or lactating (pregnancy kit will be used to check)\n* Patients who have undergone laser, radiofrequency, peeling, and other procedural therapies for anti-aging in the month prior to the study.\n* Patients with current inflammatory or infectious skin disease on the face, or history of such in the month prior to the study.\n* Patients taking OCDs and other photosensitizing drugs (e.g. tetracycline).\n* Not willing to provide informed consent"}, 'identificationModule': {'nctId': 'NCT03460860', 'briefTitle': 'Astaxanthin (2 mg) + Lycopene (1.8 mg) + D-Alpha-Tocopherol (10 IU) For The Treatment Of Skin Aging', 'organization': {'class': 'INDUSTRY', 'fullName': 'United Laboratories'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled Trial Evaluating The Safety And Efficacy Of An Oral Supplement Containing Astaxanthin (2 mg) + Lycopene (1.8 mg) + D-Alpha-Tocopherol (10 IU) For The Treatment Of Skin Aging', 'orgStudyIdInfo': {'id': 'RD2017-06 (Anti-Aging Study)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Astaxanthin (2mg)+Lycopene (1.8mg)+D-Alpha-Tocopherol (10IU)', 'interventionNames': ['Dietary Supplement: Astaxanthin (2mg)+Lycopene (1.8mg)+D-Alpha-Tocopherol (10IU)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Astaxanthin (2mg)+Lycopene (1.8mg)+D-Alpha-Tocopherol (10IU)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The intervention is to be taken once daily, for 12 weeks.', 'armGroupLabels': ['Astaxanthin (2mg)+Lycopene (1.8mg)+D-Alpha-Tocopherol (10IU)']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The intervention is to be taken once daily, for 12 weeks.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Manila', 'state': 'National Capital Region', 'country': 'Philippines', 'facility': 'PDC Building, 1440 Taft Avenue', 'geoPoint': {'lat': 14.6042, 'lon': 120.9822}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'United Laboratories', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}