Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2026-01-05 @ 5:54 PM
Study NCT ID:
NCT05869357
Status:
UNKNOWN
Last Update Posted:
2023-05-24
First Post:
2023-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety of Cream Containing Sericin and Turmeric in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D047030', 'term': 'Sericins'}], 'ancestors': [{'id': 'D047011', 'term': 'Silk'}, {'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D060829', 'term': 'Arthropod Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 106}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-22', 'studyFirstSubmitDate': '2023-05-11', 'studyFirstSubmitQcDate': '2023-05-11', 'lastUpdatePostDateStruct': {'date': '2023-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Erythema index', 'timeFrame': '19 days', 'description': 'Measure by Cutometer. It represents inflammation. The value present in scale of erythema index (0 to 1000) (high value mean a worse outcome).'}, {'measure': 'Melanin index', 'timeFrame': '19 days', 'description': 'Measure by Cutometer. It represents post-inflammatory reaction. The value present in scale of melanin index (0 to 1000) (high value mean a worse outcome).'}], 'secondaryOutcomes': [{'measure': 'Humidity index', 'timeFrame': '19 days', 'description': 'Measure by Cutometer. It represents skin humidity. The value present in scale of humidity index (0 to 1000) (high value mean a better outcome).'}, {'measure': 'Transepidermal water loss index', 'timeFrame': '19 days', 'description': 'Measure by Cutometer. It represents skin water loss. The value present in scale of transepidermal water loss index (0 to 1000) (high value mean a worse outcome).'}, {'measure': 'Skin reaction', 'timeFrame': '19 days', 'description': 'Found or not found'}, {'measure': 'Satisfaction of the volunteers', 'timeFrame': '19 days', 'description': 'Measure by visual analogue scale (1 to 10 score means low satisfaction to high satisfaction)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Safety Issues']}, 'descriptionModule': {'briefSummary': 'The object of this study was to evaluate safety of cream containing sericin and turmeric in healthy volunteers.', 'detailedDescription': 'There are 106 healthy volunteers in this study. Upper left arm is divided into 2 parts (2x2 cm) which are A and B area. Upper right arm is divided into 2 parts (2x2 cm) which are C and D area. Four area (A, B, C, and D) are randomized to receive cream containing 2.5% sericin and 2%turmeric, cream containing 5%sericin and 2%turmeric, cream containing 10%sericin and 2%turmeric, and cream base (Control group). Samples are applied 2 times/day for 6 days (Induction phase). Then, the volunteers will stop applying samples for 7 to 10 days (Free period). After that, Samples are applied 2 times/day for 3 days (Challenge phase). Erythema, melanin, humidity, transepidermal water loss, skin adverse reaction, and satisfaction are evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 to 60 years\n* No skin diseases\n* No allergy to sericin and turmeric\n* No immunocompromised disease or using steroid for 2 weeks before participated in this study\n* Willing to participate in this study\n\nExclusion Criteria:\n\n* Uncontrolled disease, cancer, and heart disease\n* Cannot follow the protocol\n* Pregnancy and lactation\n* Participated in other studies'}, 'identificationModule': {'nctId': 'NCT05869357', 'briefTitle': 'Safety of Cream Containing Sericin and Turmeric in Healthy Volunteers', 'organization': {'class': 'OTHER', 'fullName': 'Chulalongkorn University'}, 'officialTitle': 'Safety of Cream Containing Sericin and Turmeric in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'EC22010-20'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'cream containing 2.5% sericin and 2%turmeric', 'description': 'cream containing 2.5% sericin and 2%turmeric', 'interventionNames': ['Other: cream containing 2.5% sericin and 2%turmeric']}, {'type': 'EXPERIMENTAL', 'label': 'cream containing 5%sericin and 2%turmeric', 'description': 'cream containing 5% sericin and 2%turmeric', 'interventionNames': ['Other: cream containing 5%sericin and 2%turmeric']}, {'type': 'EXPERIMENTAL', 'label': 'cream containing 10%sericin and 2%turmeric', 'description': 'cream containing 10% sericin and 2%turmeric', 'interventionNames': ['Other: cream containing 10%sericin and 2%turmeric']}, {'type': 'EXPERIMENTAL', 'label': 'cream base', 'description': 'cream base without sericin and tumeric', 'interventionNames': ['Other: cream base']}], 'interventions': [{'name': 'cream containing 2.5% sericin and 2%turmeric', 'type': 'OTHER', 'description': 'Sample is applied 2 times/day for 6 days. Then, use of the sample is stopped for 7 to 10 days. After that, sample is applied 2 times/day for 3days.', 'armGroupLabels': ['cream containing 2.5% sericin and 2%turmeric']}, {'name': 'cream containing 5%sericin and 2%turmeric', 'type': 'OTHER', 'description': 'Sample is applied 2 times/day for 6 days. Then, use of the sample is stopped for 7 to 10 days. After that, sample is applied 2 times/day for 3days.', 'armGroupLabels': ['cream containing 5%sericin and 2%turmeric']}, {'name': 'cream containing 10%sericin and 2%turmeric', 'type': 'OTHER', 'description': 'Sample is applied 2 times/day for 6 days. Then, use of the sample is stopped for 7 to 10 days. After that, sample is applied 2 times/day for 3days.', 'armGroupLabels': ['cream containing 10%sericin and 2%turmeric']}, {'name': 'cream base', 'type': 'OTHER', 'description': 'Sample is applied 2 times/day for 6 days. Then, use of the sample is stopped for 7 to 10 days. After that, sample is applied 2 times/day for 3days.', 'armGroupLabels': ['cream base']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10310', 'city': 'Bangkok', 'country': 'Thailand', 'contacts': [{'name': 'Pornanong Aramwit, Ph.D', 'role': 'CONTACT', 'email': 'aramwit@gmail.com', 'phone': '+66899217255'}], 'facility': 'Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn Unviersity', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'centralContacts': [{'name': 'Pornanong Aramwit, Professor', 'role': 'CONTACT', 'email': 'aramwit@gmail.com', 'phone': '+66899217255'}], 'overallOfficials': [{'name': 'Pornanong Aramwit, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chulalongkorn University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chulalongkorn University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Pornanong Aramwit, Pharm.D., Ph.D', 'investigatorAffiliation': 'Chulalongkorn University'}}}}