Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2026-03-03 @ 6:15 AM
Study NCT ID:
NCT02965118
Status:
COMPLETED
Last Update Posted:
2018-11-20
First Post:
2016-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CAPTAIN-AD: Clinical Study of AmorePacific's TRPV1 Antagonist in 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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2018-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-18', 'studyFirstSubmitDate': '2016-11-14', 'studyFirstSubmitQcDate': '2016-11-14', 'lastUpdatePostDateStruct': {'date': '2018-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Success rate of Investigator's Global Assessment (IGA)", 'timeFrame': '8 weeks', 'description': 'Percent of patients with IGA score of 0 (clear) or 1 (almost clear)'}], 'secondaryOutcomes': [{'measure': "Change of Investigator's Global Assessment (IGA) score", 'timeFrame': '8 weeks', 'description': 'Change of IGA score from baseline'}, {'measure': "Success rate of ≥2-grade Investigator's Global Assessment (IGA)", 'timeFrame': '8 weeks', 'description': 'percent of patients with ≥2 grade reduction of IGA score'}, {'measure': 'Percent of change in Eczema Area and Severity Index (EASI)', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Atopic Dermatitis']}, 'descriptionModule': {'briefSummary': 'This is a phase III study to investigate the safety and efficacy of PAC-14028 cream in Atopic Dermatitis patients.', 'detailedDescription': 'PAC-14028 cream 1.0% or placebo will be treated to Mild to Moderate Atopic Dermatitis patients twice daily for 8 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female patients aged 12 - 70 years.\n* Who was diagnosed with Atopic Dermatitis according to Haniffin and Rajka criteria.\n* Whose affected TBSA is over 5% and below 30%, and IGA score is 2 (mild) to 3 (moderate).\n* Who voluntarily agreed to participate in the study and signed an informed consent form.\n\nExclusion Criteria:\n\n* Who has skin diseases other than atopic dermatitis or scar in the affected area which can affect the study, determined by the study investigators.\n* Who has clinically significant medical history or diseases involving liver, kidney, neurological system, psychical disorder that can affect study results.\n* Who has used systemic steroids, antibiotics, immunosuppressants, or received phototherapy within 28 days before study drug administration.\n* Who has used topical steroids, topical calcineurin inhibitors or antibiotics to treat atopic dermatitis within 14 days before study drug administration.\n* Who has used or is expected to inevitably use prohibited concomitant medications during the study.\n* Women who is pregnant /breast-feeding, or who has childbearing potential and does not use available contraceptives.\n* Who has dosed other study medications within 30 days before screening.\n* Who is determined ineligible for study participation by investigators for any other reasons.'}, 'identificationModule': {'nctId': 'NCT02965118', 'briefTitle': "CAPTAIN-AD: Clinical Study of AmorePacific's TRPV1 Antagonist in Atopic Dermatitis", 'organization': {'class': 'INDUSTRY', 'fullName': 'Amorepacific Corporation'}, 'officialTitle': 'Multi Center, Randomized, Double-blind, Placebo-controlled Parallel-group, Phase III Clinical Trial to Evaluate the Safety and Efficacy of PAC-14028 Cream in Mild to Moderate Atopic Dermatitis Patients', 'orgStudyIdInfo': {'id': 'CAPTAIN-AD-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PAC-14028 cream 1.0%', 'description': 'PAC-14028 cream 1.0% will be applied to treatment area twice daily for 8 weeks.', 'interventionNames': ['Drug: PAC-14028 cream 1.0%']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'PAC-14028 cream Vehicle', 'description': 'PAC-14028 cream Vehicle will be applied to treatment area twice daily for 8 weeks.', 'interventionNames': ['Drug: PAC-14028 cream Vehicle']}], 'interventions': [{'name': 'PAC-14028 cream 1.0%', 'type': 'DRUG', 'description': 'topical application', 'armGroupLabels': ['PAC-14028 cream 1.0%']}, {'name': 'PAC-14028 cream Vehicle', 'type': 'DRUG', 'description': 'topical application', 'armGroupLabels': ['PAC-14028 cream Vehicle']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Kyuhan Kim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amorepacific Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}