Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2026-03-02 @ 4:05 PM
Study NCT ID:
NCT02565134
Status:
COMPLETED
Last Update Posted:
2016-07-15
First Post:
2015-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Skin Pruritus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 296}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-14', 'studyFirstSubmitDate': '2015-09-30', 'studyFirstSubmitQcDate': '2015-09-30', 'lastUpdatePostDateStruct': {'date': '2016-07-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in intensity of pruritus as measured by 10 cm VAS', 'timeFrame': 'Week 4 from baseline'}], 'secondaryOutcomes': [{'measure': 'Treatment success rate (A decrease in VAS by 2 or more is judged as a success)', 'timeFrame': 'Week 4 from baseline'}, {'measure': 'Change in Overall Dry Skin (ODS) score', 'timeFrame': 'Week 4 from baseline'}, {'measure': 'Change in Transepidermal Water Loss (TEWL)', 'timeFrame': 'Week 4 from baseline'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Skin Pruritus']}, 'descriptionModule': {'briefSummary': 'The study is a Phase II, multi center, randomized, double-blind, placebo-controlled study in male and female subjects, aged ≥ 19 years with skin pruritus. All subjects will receive BID topical applications of PAC-14028 cream or vehicle for up to 4 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female patients aged 19 - 70 years\n* Patients who have eczema or xerosis cutis at the area where investigational product is applied (arm or leg)\n* Patients whose result of the pruritus test (Visual Analogue Scale, VAS) at Visit 1 and 2 is 5 or more\n* Patients whose overall dry skin score of the area where investigational product is applied at Visit 1 and 2 is 2 points or more\n\nExclusion Criteria:\n\n* Patients with pruritus caused by other medical, psychotic and nervous causes other than the skin disease\n* Patients with such skin diseases as malignant tumor or chronic urticaria among patients with skin diseases\n* Patients with simple pruritus caused by such allergic material as scabies, and insect bite wound\n* Patients with the symptom of systemic infection at the time of the participation in the clinical study\n* Patients with a history of taking topical treatment drug, topical steroid agent or antibiotics for the treatment of pruritus within 2 weeks\n* Patients with a history of taking oral steroid agent within 4 weeks\n* Patients with a history of taking a physical treatment for the treatment of pruritus including phototherapy within 4 weeks\n* Pregnant or breast-feeding women\n* Women at a childbearing age who has childbearing potential or has a plan to get pregnant during the clinical study period'}, 'identificationModule': {'nctId': 'NCT02565134', 'briefTitle': 'A Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Skin Pruritus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amorepacific Corporation'}, 'officialTitle': 'Multi Center, Double-blind, Randomized, Placebo-controlled Parallel-group, Dose Finding Phase II Clinical Trial to Evaluate Antipruritic Effect and Safety of PAC-14028 Cream (0.1%, 0.3%, 1.0%) in Skin Pruritus Patients', 'orgStudyIdInfo': {'id': 'AP-TRPV1_PII-02'}}, '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': [{'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Miyoung Park, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amorepacific R&D Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amorepacific Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}