Ignite Creation Date:
2025-12-25 @ 1:01 AM
Ignite Modification Date:
2025-12-25 @ 11:15 PM
Study NCT ID:
NCT01692093
Status:
UNKNOWN
Last Update Posted:
2013-11-14
First Post:
2012-09-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
KM110329 in Adult Patients With Atopic Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 66}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2014-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-11-12', 'studyFirstSubmitDate': '2012-09-17', 'studyFirstSubmitQcDate': '2012-09-20', 'lastUpdatePostDateStruct': {'date': '2013-11-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'TEWL', 'timeFrame': '8 weeks', 'description': 'Transepidermal Water Loss'}, {'measure': 'hydration in the stratum corneum', 'timeFrame': '8 weeks', 'description': 'hydration in the stratum corneum'}, {'measure': 'KiFDA-HM-AD', 'timeFrame': '8 weeks', 'description': 'Evaluation endpoint for clinical trial of herbal medicinal products about atopic dermatitis'}], 'primaryOutcomes': [{'measure': 'SCORAD index', 'timeFrame': '8 weeks', 'description': 'SCORing Atopic Dermatitis'}], 'secondaryOutcomes': [{'measure': 'DLQI', 'timeFrame': '8 weeks', 'description': 'The Dermatology Life Quality Index'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['SCORAD', 'Atopic dermatits', 'Skin health'], 'conditions': ['Atopic Dermatitis']}, 'referencesModule': {'references': [{'pmid': '24279519', 'type': 'DERIVED', 'citation': 'Cheon C, Park S, Park JS, Oh SM, Jang S, Go HY, Jang BH, Shin YC, Ko SG. KM110329 in adult patients with atopic dermatitis: a randomised, double-blind, placebo-controlled, multicentre trial--study protocol. BMC Complement Altern Med. 2013 Nov 27;13:335. doi: 10.1186/1472-6882-13-335.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine clinical efficacy and safety of KM110329 for Atopic dermatitis.', 'detailedDescription': "A randomized, double blind, placebo-controlled, multicenter trial will be conducted at the Seoul St.Mary's Hospital, at Chung-ang University hospital, and at Kyung Hee University Hospital at Gangdong.\n\nParticipants fulfilling eligibility criteria will be selected. Enrolled participants will be randomly allocated to two parallel groups: the KM110329 and placebo arms.\n\nEach participant will be examined for signs and symptoms of Atopic dermatitis before and after taking functional food."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women ages 18 to 65 years\n* Individuals who diagnosed Atopic dermatitis according to the criteria of Hanifin and Rajka\n* Individuals who mild to moderate atopic dermatitis (objective SCORAD≤40)\n* Written informed consent for participation in the trial\n\nExclusion Criteria:\n\n* Severe skin disease other than Atopic dermatitis\n* Secondary infection with bacteria, fungi, and virus\n* Uncontrolled hypertension (SBP \\> 145 mmHg or DBP \\> 95 mmHg)\n* Severe liver disability (2.5-fold the normal high range value for ALT, AST)\n* Severe renal disability (sCr \\> 2.0mg/dl)\n* Women who are pregnant, lactating, planning a pregnancy or women of child-bearing age who do not agree to proper contraception\n* Use of oral steroids, oral antibiotic or other immunosuppressants within the past 4 weeks\n* Treated by systemic photochemotherapy within past 4 weeks\n* History of drug abuse\n* Hypersensitivity to Rubi Fructus, Houttuyniae Herba, Rehmanniae Radix, Betulae Platyphyllae Cortex\n* Use of other investigational products within the past two months'}, 'identificationModule': {'nctId': 'NCT01692093', 'briefTitle': 'KM110329 in Adult Patients With Atopic Dermatitis', 'organization': {'class': 'OTHER', 'fullName': 'Kyunghee University Medical Center'}, 'officialTitle': 'KM110329 in Adult Patients With Atopic Dermatitis : a Randomised, Double-blind, Placebo-controlled, Multicenter Trial', 'orgStudyIdInfo': {'id': 'CCRG_KM110329'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'KM110329', 'description': 'Participants will receive KM110329 for eight weeks. Participants will take 2 tablets by mouth with water two times a day after meals.', 'interventionNames': ['Dietary Supplement: KM110329']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Participants will receive placebo drug for eight weeks. Participants will take 2 tablets by mouth with water two times a day after meals.', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'KM110329', 'type': 'DIETARY_SUPPLEMENT', 'description': 'KM110329, a functional food consist of four herbs which are shown to be beneficial for skin health', 'armGroupLabels': ['KM110329']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '130-701', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'CHUNHOO CHEON, M.D.(DKM)', 'role': 'CONTACT', 'email': 'pm.thehoo@gmail.com', 'phone': '82-2-961-9278'}], 'facility': 'Kyung Hee University', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'SEONG GYU KO, M.D.(DKM)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kyunghee University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyunghee University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': "St Mary's Hospital, London", 'class': 'OTHER'}, {'name': 'Chung-Ang University Hosptial, Chung-Ang University College of Medicine', 'class': 'OTHER'}, {'name': 'Kyung Hee University Hospital at Gangdong', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Seong-Gyu Ko', 'investigatorAffiliation': 'Kyunghee University Medical Center'}}}}