Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2025-12-30 @ 6:52 PM
Study NCT ID:
NCT05045469
Status:
COMPLETED
Last Update Posted:
2025-04-01
First Post:
2021-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Therapeutic Effects of Topical Herbal Medicine -Rhubarb Ointment on Rosacea
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012393', 'term': 'Rosacea'}], 'ancestors': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': '10356017a@cgmh.org.tw', 'phone': '0978839349', 'title': 'Dr. HuanHsuan Hsu', 'organization': 'CGMH'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Group A (Dian Dao San Group)', 'description': 'Herbal medicine (dian dao san) will be applied to the lesions of rosacea twice a day. Subject will receive persistent treatment for 6 weeks.\n\ndian dao san: dian dao san and placebo will be used in the rosacea lesions twice a day for 6 weeks', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group B( Topical Medicine Without Therapeutic Effects)', 'description': 'Placebo (topical medicine without therapeutic effects) will be applied to the lesions of rosacea twice a day. Subject will receive persistent treatment for 6 weeks.\n\ndian dao san: dian dao san and placebo will be used in the rosacea lesions twice a day for 6 weeks', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Reduction of Flushing, Erythema, Telangiectasia, Papules, and Pustules', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A (Dian Dao San Group)', 'description': 'Herbal medicine (dian dao san) will be applied to the lesions of rosacea twice a day. Subject will receive persistent treatment for 6 weeks.\n\ndian dao san: dian dao san and placebo will be used in the rosacea lesions twice a day for 6 weeks'}, {'id': 'OG001', 'title': 'Group B( Topical Medicine Without Therapeutic Effects)', 'description': 'Placebo (topical medicine without therapeutic effects) will be applied to the lesions of rosacea twice a day. Subject will receive persistent treatment for 6 weeks.\n\ndian dao san: dian dao san and placebo will be used in the rosacea lesions twice a day for 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'spread': '0.43', 'groupId': 'OG000'}, {'value': '1.92', 'spread': '0.67', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': 'quantified by Investigator Global Assessment, IGA. IGA is used in the study for assessing the severity of rosacea ranging from 0 (clean) to 4 (most severe).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Dermatology Quality of Life Index, DQoL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A (Dian Dao San Group)', 'description': 'Herbal medicine (dian dao san) will be applied to the lesions of rosacea twice a day. Subject will receive persistent treatment for 6 weeks.\n\ndian dao san: dian dao san and placebo will be used in the rosacea lesions twice a day for 6 weeks'}, {'id': 'OG001', 'title': 'Group B( Topical Medicine Without Therapeutic Effects)', 'description': 'Placebo (topical medicine without therapeutic effects) will be applied to the lesions of rosacea twice a day. Subject will receive persistent treatment for 6 weeks.\n\ndian dao san: dian dao san and placebo will be used in the rosacea lesions twice a day for 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '2.83', 'spread': '2.25', 'groupId': 'OG000'}, {'value': '6.25', 'spread': '4.49', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': 'DQoL is a questionnaire-based scale designed to measure the impact of dermatological conditions on a patient\'s quality of life. It assesses various aspects, including symptoms, psychological well-being, social activities, and treatment-related effects.\n\nScale Range:The DQoL consists of 10 questions, each scored on a scale from 0 to 3:\n\n0 = Not at all, 1 = A little,2 = A lot,3 = Very much The total score ranges from 0 to 30, where higher scores indicate a greater negative impact of the skin condition on quality of life.\n\nInterpretation of Scale Scores:\n\nTotal Score 0-1: No or minimal impact; 2-5: Mild impact; 6-10: Moderate impact; 11-20: Significant impact; 21-30: Severe impact Higher DQoL scores indicate worse quality of life due to the skin condition, while lower scores suggest minimal impact.\n\nComputation of Scores:DQoL total score is calculated as the sum of the 10 item scores.\n\nUnit of Measure:\n\n"Scores on a scale" should be used as the Unit of Measure if no other units apply.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group A (Dian Dao San Group)', 'description': 'Herbal medicine (dian dao san) will be applied to the lesions of rosacea twice a day. Subject will receive persistent treatment for 6 weeks.\n\ndian dao san: dian dao san and placebo will be used in the rosacea lesions twice a day for 6 weeks'}, {'id': 'FG001', 'title': 'Group B( Topical Medicine Without Therapeutic Effects)', 'description': 'Placebo (topical medicine without therapeutic effects) will be applied to the lesions of rosacea twice a day. Subject will receive persistent treatment for 6 weeks.\n\ndian dao san: dian dao san and placebo will be used in the rosacea lesions twice a day for 6 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Group A (Dian Dao San Group)', 'description': 'Herbal medicine (dian dao san) will be applied to the lesions of rosacea twice a day. Subject will receive persistent treatment for 6 weeks.\n\ndian dao san: dian dao san and placebo will be used in the rosacea lesions twice a day for 6 weeks'}, {'id': 'BG001', 'title': 'Group B( Topical Medicine Without Therapeutic Effects)', 'description': 'Placebo (topical medicine without therapeutic effects) will be applied to the lesions of rosacea twice a day. Subject will receive persistent treatment for 6 weeks.\n\ndian dao san: dian dao san and placebo will be used in the rosacea lesions twice a day for 6 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.08', 'spread': '14.94', 'groupId': 'BG000'}, {'value': '52.08', 'spread': '10.93', 'groupId': 'BG001'}, {'value': '46.58', 'spread': '12.94', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Taiwan', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-03-12', 'size': 102180, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-03-13T04:04', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-08-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-13', 'studyFirstSubmitDate': '2021-09-07', 'resultsFirstSubmitDate': '2025-02-16', 'studyFirstSubmitQcDate': '2021-09-07', 'lastUpdatePostDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-03-13', 'studyFirstPostDateStruct': {'date': '2021-09-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction of Flushing, Erythema, Telangiectasia, Papules, and Pustules', 'timeFrame': '6 weeks', 'description': 'quantified by Investigator Global Assessment, IGA. IGA is used in the study for assessing the severity of rosacea ranging from 0 (clean) to 4 (most severe).'}], 'secondaryOutcomes': [{'measure': 'Dermatology Quality of Life Index, DQoL', 'timeFrame': '6 weeks', 'description': 'DQoL is a questionnaire-based scale designed to measure the impact of dermatological conditions on a patient\'s quality of life. It assesses various aspects, including symptoms, psychological well-being, social activities, and treatment-related effects.\n\nScale Range:The DQoL consists of 10 questions, each scored on a scale from 0 to 3:\n\n0 = Not at all, 1 = A little,2 = A lot,3 = Very much The total score ranges from 0 to 30, where higher scores indicate a greater negative impact of the skin condition on quality of life.\n\nInterpretation of Scale Scores:\n\nTotal Score 0-1: No or minimal impact; 2-5: Mild impact; 6-10: Moderate impact; 11-20: Significant impact; 21-30: Severe impact Higher DQoL scores indicate worse quality of life due to the skin condition, while lower scores suggest minimal impact.\n\nComputation of Scores:DQoL total score is calculated as the sum of the 10 item scores.\n\nUnit of Measure:\n\n"Scores on a scale" should be used as the Unit of Measure if no other units apply.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rosacea', 'Chinese Herbal Medicine']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the effects of topical herbal medicine in the patients with rosacea.', 'detailedDescription': 'Rosacea is a chronic inflammatory disorder which affects the cheek, nose, chin, forehead and eyes. It is typically characterized by cutaneous signs such as flushing, erythema, telangiectasia, papules, and pustules in the face. The pathogenic mechanism of rosacea is unknown, and there is no cure for rosacea. The therapeutic approaches include oral medicine, topical medicine and surgical interventions depending on the different subtypes of rosacea. The recent study demonstrates that combination therapy may be more effectively improved the symptoms of rosacea. Dian dao san is a topical herbal compound for reducing the features as flushing, erythema, papules, and pustules for years. The investigators hypothesize that dian dao san can be more beneficial in treating the patients with rosacea and improving the quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Willing to sign inform consent\n* Aged above 20 years old with rosacea\n* No treatment for rosacea within 2 weeks\n\nExclusion Criteria:\n\n* With malignant lesion in the rosacea lesion\n* Rosacea lesion with high risk of infection\n* Allergy to Chinese herbal medicine patch or ointment\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT05045469', 'briefTitle': 'Therapeutic Effects of Topical Herbal Medicine -Rhubarb Ointment on Rosacea', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'Therapeutic Effects of Topical Herbal Medicine on Rosacea', 'orgStudyIdInfo': {'id': '202101000A3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'group A (dian dao san group)', 'description': 'Herbal medicine (dian dao san) will be applied to the lesions of rosacea twice a day. Subject will receive persistent treatment for 6 weeks.', 'interventionNames': ['Drug: dian dao san']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'group B( topical medicine without therapeutic effects)', 'description': 'Placebo (topical medicine without therapeutic effects) will be applied to the lesions of rosacea twice a day. Subject will receive persistent treatment for 6 weeks.', 'interventionNames': ['Drug: dian dao san']}], 'interventions': [{'name': 'dian dao san', 'type': 'DRUG', 'description': 'dian dao san and placebo will be used in the rosacea lesions twice a day for 6 weeks', 'armGroupLabels': ['group A (dian dao san group)', 'group B( topical medicine without therapeutic effects)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Keelung', 'country': 'Taiwan', 'facility': 'Keelung Chang Gung Memorial Hospital', 'geoPoint': {'lat': 25.13089, 'lon': 121.74094}}], 'overallOfficials': [{'name': 'YUAN-CHIEH YEH, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chang Gung Memorial Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}