Ignite Creation Date:
2025-12-24 @ 11:46 AM
Ignite Modification Date:
2026-01-16 @ 6:46 AM
Study NCT ID:
NCT06886061
Status:
COMPLETED
Last Update Posted:
2025-03-20
First Post:
2025-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Continuous Intake of Ergothioneine-containing Supplements on Skin Condition
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-10-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-03-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-13', 'studyFirstSubmitDate': '2025-03-03', 'studyFirstSubmitQcDate': '2025-03-13', 'lastUpdatePostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Brightness & Color', 'timeFrame': 'Before the trial begins, at 4 weeks, and at 8 weeks.', 'description': 'Using the SPECTRO PHOTOMETER NF555 (Japan Electric Color Industry Co., Ltd.), measure the brightness and color at the intersection points of vertical lines below both outer canthi and horizontal lines from the alae nasi. The L\\*a\\*b\\* method is used to measure L\\* value (brightness), a\\* value, and b\\* value (color). Higher values indicate brighter or more intense colors.'}, {'measure': 'Melanin', 'timeFrame': 'Before the trial begins, at 4 weeks, and at 8 weeks.', 'description': 'Using the Mexameter® MX 18 (Courage+Khazaka electronic GmbH), measure melanin at the same facial points as above to assess the content of melanin.'}, {'measure': 'Erythema', 'timeFrame': 'Before the trial begins, at 4 weeks, and at 8 weeks.', 'description': 'Using the Mexameter® MX 18 (Courage+Khazaka electronic GmbH), measure erythema at the same facial points as above to assess the content of erythema.'}, {'measure': 'Gloss (Shine)', 'timeFrame': 'Before the trial begins, at 4 weeks, and at 8 weeks.', 'description': 'Using the Glossymeter GL200MP (Courage+Khazaka electronic GmbH), measure the gloss at the specified facial points. This device measures true gloss unaffected by skin surface texture or color.'}, {'measure': 'Elasticity', 'timeFrame': 'Before the trial begins, at 4 weeks, and at 8 weeks.', 'description': 'Using the Cutometer® MPA580 (Courage+Khazaka electronic GmbH), measure elasticity at the designated facial points. Skin elasticity is evaluated through R2 (total elasticity), R5 (net elasticity), and R7 (elasticity upon retraction) ratios.'}, {'measure': 'Spots', 'timeFrame': 'Before the trial begins, at 4 weeks, and at 8 weeks.', 'description': 'Using VISIA® Evolution (Canfield Scientific Inc.), measure spots on both sides of the face at the defined locations. Assess the number of spots.'}], 'secondaryOutcomes': [{'measure': 'Skin Condition', 'timeFrame': 'Before the trial begins, at 4 weeks, and at 8 weeks.', 'description': 'Conduct three surveys before the trial begins, and at 4 and 8 weeks into the trial, covering 11 items: "moisture," "dryness," "softness," "gloss," "smoothness," "skin allergy condition," "texture," "makeup adherence," "tightness," "wrinkles," "transparency," "tightness after washing," "brightness," and overall skin satisfaction. Participants rate these aspects on a 9-point scale ranging from "very poor" to "very good."'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ergothioneine', 'Skin', 'Supplements'], 'conditions': ['Skin']}, 'descriptionModule': {'briefSummary': 'This trial employed a non-randomized, double-blind, placebo-controlled design to evaluate the effects of DR. ERGO® Capsules (each containing 30mg of ergothioneine) on the skin condition of women aged 35 to 59 after continuous daily intake for 8 weeks. The trial assessed skin condition across multiple dimensions, including brightness, color tone, melanin, erythema, gloss, elasticity, and spots, using various instruments and questionnaire surveys. Additionally, safety was monitored through daily log records and safety evaluations.', 'detailedDescription': 'Ergothioneine (EGT), a naturally occurring amino acid-like antioxidant, was first discovered in Clavieps purpurea in 1909. It is widely found in mushrooms, legumes, and certain animal tissues. Studies have shown that ergothioneine protects skin cells by scavenging free radicals and reducing oxidative stress, thereby delaying skin aging. Additionally, it can inhibit melanin production, improve uneven skin tone, enhance the skin barrier function, and boost skin elasticity and radiance. In recent years, with growing attention to nutricosmetics, ergothioneine has gained significant interest for its potential anti-aging and skin-enhancing benefits.\n\nThe trial employed a non-randomized, double-blind, placebo-controlled design, adhering to the principles of the Helsinki Declaration and relevant Japanese ethical guidelines, and received approval from an ethics review committee. The primary objective of the study was to evaluate the effects of daily consumption of one DR. ERGO® capsule (each containing 30mg of ergothioneine) on the skin condition of women aged 35 to 59 over an 8-week period.\n\nThe trial design included strict inclusion and exclusion criteria to ensure consistency in the health status and testing conditions of the participants. During the trial, participants were required to maintain their normal lifestyle habits and avoid using any medications or cosmetics that might affect their skin condition. The study assessed skin condition across multiple dimensions-including brightness, color tone, melanin levels, erythema, gloss, elasticity, spots, and wrinkles-using various instruments and questionnaires. Additionally, safety was monitored through diary logs and safety assessments.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n① Healthy women aged 35 to 59 years old.\n\n② Individuals who feel that their skin condition is deteriorating (loss of radiance, dullness, pigmentation spots, etc.).\n\nExclusion Criteria:\n\n* Individuals with a history of food allergies.\n\n * Pregnant or breastfeeding individuals.\n\n * Individuals with inflammation or wounds on their face.\n\n * Individuals taking medication that could affect the trial. ⑤ Individuals consuming health supplements that could affect the trial.\n\n ⑥ Individuals currently undergoing medical treatment or receiving prescriptions from a doctor.\n\n ⑦ Individuals undergoing hormone therapy.\n\n ⑧ Individuals with eyelash extensions, permanent eyeliner, or other forms of cosmetic tattooing around the eyes.\n\n ⑨ Individuals who have participated in human clinical trials within the last month or plan to do so during the trial period.\n\n ⑩ Individuals deemed unsuitable by the principal investigator of the trial.'}, 'identificationModule': {'nctId': 'NCT06886061', 'acronym': 'EGTCLINIC', 'briefTitle': 'Effect of Continuous Intake of Ergothioneine-containing Supplements on Skin Condition', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shanghai EGT Synbio Group Co., Ltd.'}, 'officialTitle': 'Effect of Continuous Intake of Ergothioneine-containing Supplements on Skin Condition: a Randomized, Double Blind, Placebo-controlled Study', 'orgStudyIdInfo': {'id': 'UMIN000055792'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Group', 'description': 'The placebo group continuously ingests capsules without Ergothioneine over a period of 8 weeks.', 'interventionNames': ['Dietary Supplement: The capsules do not contain Ergothioneine.']}, {'type': 'EXPERIMENTAL', 'label': 'Ergothioneine Group', 'description': 'The Ergothioneine group continuously ingests one capsule containing 30mg of Ergothioneine per day over a period of 8 weeks.', 'interventionNames': ['Dietary Supplement: The capsules contain Ergothioneine.']}], 'interventions': [{'name': 'The capsules contain Ergothioneine.', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Take one 30 mg Ergothioneine capsule orally every day for a period of eight weeks.', 'armGroupLabels': ['Ergothioneine Group']}, {'name': 'The capsules do not contain Ergothioneine.', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Take one capsule devoid of Ergothioneine orally every day for a period of eight weeks.', 'armGroupLabels': ['Placebo Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tokyo', 'state': 'Shinjukuku', 'country': 'Japan', 'facility': 'Japan Clinical Trial Association N.A.', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'Kaneko Takeshi', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Japan Clinical Trial Association'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai EGT Synbio Group Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}