Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-27 @ 11:56 PM
Study NCT ID:
NCT05378360
Status:
COMPLETED
Last Update Posted:
2024-04-04
First Post:
2022-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DWP708 for Treating Epidermal Growth Factor Receptor Inhibitor Related Skin Toxicities
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017486', 'term': 'Acneiform Eruptions'}], 'ancestors': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2023-12-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-03', 'studyFirstSubmitDate': '2022-05-12', 'studyFirstSubmitQcDate': '2022-05-12', 'lastUpdatePostDateStruct': {'date': '2024-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To estimate the response rate of Rash acneiform', 'timeFrame': 'Up to 28 days', 'description': 'The effectiveness of the DWP708 was defined as follows:\n\n1. Downgraded to more than 2 steps\n2. Downgraded to ≤Grade 1'}], 'secondaryOutcomes': [{'measure': "To evaluate the patients' Quality of Life (QoL) by Skin evaluation method", 'timeFrame': 'Up to 56 days', 'description': 'SKINDEX-16'}, {'measure': 'To estimate the amount of change papule and/or pustule', 'timeFrame': 'Up to 56 days', 'description': 'Region of interest (10 \\* 10 cm)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rash Acneiform']}, 'descriptionModule': {'briefSummary': 'A Multi-center, Randomized, Double-blind, Placebo-controlled, Therapeutic Exploratory, Phase II Clinical Trial for the Efficacy Investigation and Safety Evaluation of DWP708 for Treating Rash Acneiform', 'detailedDescription': "All the patients had Grade ≥2 ERSEs according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) v. 5.0"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age: older than 19\n2. Eastern Cooperative Oncology Group (ECOG) performance status 0 -2\n3. Patients who have Rash acneiform Gr≥2 (NCI CTCAE v5.0)\n4. Patients who are currently administering EGFR TKI or EGFR mAb\n\nExclusion Criteria:\n\n1. Known allergies, hypersensitivity, or intolerance to study drugs, chemotherapy drugs using this clinical trial\n2. Patients with a history of topical medication\n\n * Steroids within 3 days prior to baseline visit\n * Antihistamine, Antipruritic agents, Antibiotics agents within 1 week prior to baseline visit\n * Tacrolimus, Pimecrolimus within 2 weeks prior to baseline visit'}, 'identificationModule': {'nctId': 'NCT05378360', 'briefTitle': 'DWP708 for Treating Epidermal Growth Factor Receptor Inhibitor Related Skin Toxicities', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daewoong Pharmaceutical Co. LTD.'}, 'officialTitle': 'A Multi-center, Randomized, Double-blind, Placebo-controlled, Therapeutic Exploratory, Phase II Clinical Trial for the Efficacy Investigation and Safety Evaluation of DWP708', 'orgStudyIdInfo': {'id': 'DW_DWP708201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo of DWP708', 'description': 'EGF Cream Placebo evenly apply to skin lesion every 12 hr/day', 'interventionNames': ['Biological: DWP708']}, {'type': 'EXPERIMENTAL', 'label': 'DWP708 10 ug/g', 'description': 'EGF Cream 10 ug/g evenly apply to skin lesion every 12 hr/day', 'interventionNames': ['Biological: DWP708']}, {'type': 'EXPERIMENTAL', 'label': 'DWP708 20 ug/g', 'description': 'EGF Cream 20 ug/g evenly apply to skin lesion every 12 hr/day', 'interventionNames': ['Biological: DWP708']}, {'type': 'EXPERIMENTAL', 'label': 'DWP708 40 ug/g', 'description': 'EGF Cream 40 ug/g evenly apply to skin lesion every 12 hr/day', 'interventionNames': ['Biological: DWP708']}], 'interventions': [{'name': 'DWP708', 'type': 'BIOLOGICAL', 'otherNames': ['EGF cream'], 'description': 'Placebo Comparator: Placebo of DWP708 / BID / up to 28 days Experimental: DWP708 10 ug/g / BID / up to 28 days Experimental: DWP708 20 ug/g / BID / up to 28 days Experimental: DWP708 40 ug/g / BID / up to 28 days', 'armGroupLabels': ['DWP708 10 ug/g', 'DWP708 20 ug/g', 'DWP708 40 ug/g', 'Placebo of DWP708']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49201', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Dong-A University Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}], 'overallOfficials': [{'name': 'Sung Yong Oh, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dong-A University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daewoong Pharmaceutical Co. LTD.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}