Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2026-02-24 @ 1:16 AM
Study NCT ID:
NCT02748993
Status:
COMPLETED
Last Update Posted:
2018-11-20
First Post:
2016-04-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Pediatric 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': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2018-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-18', 'studyFirstSubmitDate': '2016-04-20', 'studyFirstSubmitQcDate': '2016-04-21', 'lastUpdatePostDateStruct': {'date': '2018-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Success rate of Investigator's Global Assessment (IGA)", 'timeFrame': '4 weeks', 'description': '% of patients with IGA score of 0 (clear) or 1 (almost clear)'}, {'measure': 'Blood concentrations of PAC-14028', 'timeFrame': 'Day 1, Day 28', 'description': 'Blood concentrations of PAC-14028'}], 'secondaryOutcomes': [{'measure': "Change of IGA (Investigator's Global Assessment)", 'timeFrame': '1, 2, 4 week(s)', 'description': 'Change of IGA score from baseline'}, {'measure': 'Change of SCORAD (Severity Scoring of Atopic Dermatitis)', 'timeFrame': '1, 2, 4 week(s)', 'description': 'Change of SCORAD from baseline'}, {'measure': '% Change of EASI (Eczema Area and Severity Index)', 'timeFrame': '1, 2, 4 week(s)'}, {'measure': 'Patient satisfaction measurement', 'timeFrame': '4 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Atopic Dermatitis']}, 'descriptionModule': {'briefSummary': 'This is a phase 1 and 2 study to assess the safety and efficacy of PAC-14028 cream in children with atopic dermatitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '24 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female patients aged 24 months - 12 years\n* Who was diagnosed with Atopic Dermatitis according to Haniffin and Rajka criteria, whose affected BSA is over 5% and IGA score is 2 (mild) to 3 (moderate).\n* Who has applied stable amount of emollients daily before baseline visit\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, psychial disorder that can affect study results.\n* Who has used systemic steroids, antibiotics, immunosuppressants, or received photochemical therapy within 28 days before study drug administration.\n* Who has used topical steroids, immunosuppressants 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': 'NCT02748993', 'briefTitle': 'A Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Pediatric Atopic Dermatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amorepacific Corporation'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-Controlled, Parallel Study to Investigate the Safety, Tolerability, Systemic Exposure and Efficacy of PAC-14028 in Children With Mild to Moderate Pediatric Atopic Dermatitis', 'orgStudyIdInfo': {'id': 'AP-TRPV1_PII-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PAC-14028 Cream 0.1%', 'description': 'PAC-14028 Cream 0.1%, Twice daily for 4 weeks', 'interventionNames': ['Drug: PAC-14028 Cream 0.1%']}, {'type': 'EXPERIMENTAL', 'label': 'PAC-14028 Cream 0.3%', 'description': 'PAC-14028 Cream 0.3%, Twice daily for 4 weeks', 'interventionNames': ['Drug: PAC-14028 Cream 0.3%']}, {'type': 'EXPERIMENTAL', 'label': 'PAC-14028 Cream 1.0%', 'description': 'PAC-14028 Cream 1.0%, Twice daily for 4 weeks', 'interventionNames': ['Drug: PAC-14028 Cream 1.0%']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'PAC-14028 Cream Vehicle', 'description': 'PAC-14028 Cream Vehicle, twice daily for 4 weeks', 'interventionNames': ['Drug: PAC-14028 Cream Vehicle']}], 'interventions': [{'name': 'PAC-14028 Cream 0.1%', 'type': 'DRUG', 'description': 'Topical application', 'armGroupLabels': ['PAC-14028 Cream 0.1%']}, {'name': 'PAC-14028 Cream 0.3%', 'type': 'DRUG', 'description': 'Topical application', 'armGroupLabels': ['PAC-14028 Cream 0.3%']}, {'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': 'Chung-ang University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Konkuk University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'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'}}}}