Ignite Creation Date:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2026-01-01 @ 12:54 AM
Study NCT ID:
NCT07133204
Status:
COMPLETED
Last Update Posted:
2025-08-20
First Post:
2025-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Efficacy and Safety of Cream Infused With HuangQin (Root of Scutellaria Baicalensis) Extract for the Reduction of Hyperpigmentation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017495', 'term': 'Hyperpigmentation'}], 'ancestors': [{'id': 'D010859', 'term': 'Pigmentation Disorders'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C499814', 'term': 'Scutellaria baicalensis extract'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-07-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-13', 'studyFirstSubmitDate': '2025-08-13', 'studyFirstSubmitQcDate': '2025-08-13', 'lastUpdatePostDateStruct': {'date': '2025-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of hyperpigmentation reduction property of the intervention', 'timeFrame': 'Week 0, 1, 2 and 4', 'description': 'Measured the melanin index of the hyperpigmented area'}, {'measure': 'Safefty profile of the intervention', 'timeFrame': 'Week 1, 2 and 4', 'description': 'Record and collect the adverse effect from the usage of the interventional cream'}], 'secondaryOutcomes': [{'measure': 'Efficacy of erythema reduction property of the intervention', 'timeFrame': 'Week 0, 1, 2 and 4', 'description': 'Measured the erythema index of the hyperpigmented area'}, {'measure': 'Efficacy of skin hydration property of the intervention', 'timeFrame': 'Week 0, 1, 2 and 4', 'description': 'Measured the skin hydration value of the hyperpigmented area'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hyperpigmentation, scutellaria baicalensis, melanin index'], 'conditions': ['Hyperpigmentation; Melanin']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the efficacy of a topical cream infused with Scutellaria baicalensis extract in reducing hyperpigmentation on the face.\n\nThe study is experimental clinical pilot study as a single group pretest-posttest.\n\nA ROAT is conducted 1 week prior to the experiment. Participant apply the cream on the hypigmented area daily. Facial skin parameters (i.e. melanin index, erythema index) is evaluated at week 0, 1, 2 and 4.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or Female\n* Has at least 1 hyperpigmentation spot (size \\> 3mm) on either side of the face\n* 30-60 y/o\n* Fitzpatrick skin types II-IV\n* Agrees to use sunscreen SPF50+ and willing to avoid strong sunlight exposure during the study\n\nExclusion Criteria:\n\n* Pregnant or lactating\n* Use of whitening products or treatment within 1 month before this study\n* Currently using contraceptives\n* History of allergy to any ingredient in the intervention cream\n* Has skin conditions which can interfere with the measurement (i.e. severe acne, eczema, herpes simplex)\n* Severe disease (i.e. immunodeficiency, cancer)\n* Enrolled in other clinical study within 3 month before this study'}, 'identificationModule': {'nctId': 'NCT07133204', 'briefTitle': 'Study of Efficacy and Safety of Cream Infused With HuangQin (Root of Scutellaria Baicalensis) Extract for the Reduction of Hyperpigmentation', 'organization': {'class': 'OTHER', 'fullName': 'Mae Fah Luang University'}, 'officialTitle': 'Study of Efficacy and Safety of Cream Infused With HuangQin (Root of Scutellaria Baicalensis) Extract for the Reduction of Hyperpigmentation', 'orgStudyIdInfo': {'id': 'EC 24061-25'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study arm', 'interventionNames': ['Other: Investigator developed cream infused with HuangQin extract']}], 'interventions': [{'name': 'Investigator developed cream infused with HuangQin extract', 'type': 'OTHER', 'description': 'A water in oil emulsion with consistency similar to cold cream. Infused with organic extract of scutellaria baicalensis.', 'armGroupLabels': ['Study arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '57100', 'city': 'Muang', 'state': 'Changwat Chiang Rai', 'country': 'Thailand', 'facility': 'Mae Fah Luang University'}], 'overallOfficials': [{'name': 'Chakree C Wattanasiri, RPh PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mae Fah Luang University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mae Fah Luang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}