Ignite Creation Date:
2025-12-24 @ 4:58 PM
Ignite Modification Date:
2025-12-28 @ 8:18 AM
Study NCT ID:
NCT01931150
Status:
COMPLETED
Last Update Posted:
2017-01-13
First Post:
2013-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Prophylactic Topical Dapsone 5% Gel Versus Moisturizer for Cetuximab-induced Papulopustular (Acneiform) Rash in Patients With mCRC or HNSCC Without Previous or Concurrent RT
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D005076', 'term': 'Exanthema'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003622', 'term': 'Dapsone'}, {'id': 'D005782', 'term': 'Gels'}, {'id': 'D000900', 'term': 'Anti-Bacterial Agents'}], 'ancestors': [{'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003102', 'term': 'Colloids'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D000890', 'term': 'Anti-Infective Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'LacoutuM@mskcc.org', 'phone': '646-888-6014', 'title': 'Dr. Mario Lacouture', 'organization': 'Memorial Sloan Kettering Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Dapsone LEFT, Moisturizer RIGHT', 'description': 'Arm1: Receive oral antibiotics AND apply Dapsone 5% gel to LEFT side of face and chest BID (morning and evening), AND moisturizer to RIGHT side of face and chest BID (morning and evening), for 28 +/- 2 days.', 'otherNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Dapsone RIGHT, Moisturizer LEFT', 'description': 'Arm 2: Receive oral antibiotics AND apply Dapsone 5% to RIGHT side of face and chest BID (morning and evening), AND moisturizer to LEFT side of face and chest BID (morning and evening), for 28 +/- 2 days.', 'otherNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Allergic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-4.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Patients in Which the PI Observed a Notable Difference in the Number of Lesions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapsone LEFT, Moisturizer RIGHT', 'description': 'Arm1: Receive oral antibiotics AND apply Dapsone 5% gel to LEFT side of face and chest BID (morning and evening), AND moisturizer to RIGHT side of face and chest BID (morning and evening), for 28 +/- 2 days.'}, {'id': 'OG001', 'title': 'Dapsone RIGHT, Moisturizer LEFT', 'description': 'Arm 2: Receive oral antibiotics AND apply Dapsone 5% to RIGHT side of face and chest BID (morning and evening), AND moisturizer to LEFT side of face and chest BID (morning and evening), for 28 +/- 2 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '28 days', 'description': 'Change from Baseline in the Number of Lesions at 28 days', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dapsone LEFT, Moisturizer RIGHT', 'description': 'Arm1: Receive oral antibiotics AND apply Dapsone 5% gel to LEFT side of face and chest BID (morning and evening), AND moisturizer to RIGHT side of face and chest BID (morning and evening), for 28 +/- 2 days.'}, {'id': 'FG001', 'title': 'Dapsone RIGHT, Moisturizer LEFT', 'description': 'Arm 2: Receive oral antibiotics AND apply Dapsone 5% to RIGHT side of face and chest BID (morning and evening), AND moisturizer to LEFT side of face and chest BID (morning and evening), for 28 +/- 2 days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Dapsone LEFT, Moisturizer RIGHT', 'description': 'Arm1: Receive oral antibiotics AND apply Dapsone 5% gel to LEFT side of face and chest BID (morning and evening), AND moisturizer to RIGHT side of face and chest BID (morning and evening), for 28 +/- 2 days.'}, {'id': 'BG001', 'title': 'Dapsone RIGHT, Moisturizer LEFT', 'description': 'Arm 2: Receive oral antibiotics AND apply Dapsone 5% to RIGHT side of face and chest BID (morning and evening), AND moisturizer to LEFT side of face and chest BID (morning and evening), for 28 +/- 2 days.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-18', 'studyFirstSubmitDate': '2013-08-26', 'resultsFirstSubmitDate': '2016-01-19', 'studyFirstSubmitQcDate': '2013-08-28', 'lastUpdatePostDateStruct': {'date': '2017-01-13', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-11-18', 'studyFirstPostDateStruct': {'date': '2013-08-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients in Which the PI Observed a Notable Difference in the Number of Lesions', 'timeFrame': '28 days', 'description': 'Change from Baseline in the Number of Lesions at 28 days'}]}, 'conditionsModule': {'keywords': ['Topical Dapsone 5% Gel', 'Moisturizer', 'rash', '13-012'], 'conditions': ['Cetuximab-induced Papulopustular (Acneiform) Rash Who Have', 'Metastatic Colorectal Cancer or Head and Neck Squamous Cell Carcinoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mskcc.org/', 'label': 'Memorial Sloan Kettering Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to see if the investigators can prevent or reduce the severity of the Cetuximab-related acne rash. Two different topical agents will be applied to the skin. One topical agent is the dapsone gel and the other is a skin moisturizer. Dapsone gel is an FDA approved medication that you apply to the face. It is commonly used to treat acne. Skin moisturizers are recommended to patients who receive Cetuximab treatment. In addition to these topical agents they will be given a pill to take once a day. This pill has already been shown to help fight rashes from Cetuximab.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients 18 years or older with underlying diagnosis of metastatic colorectal cancer or head and neck squamous cell carcinoma including newly diagnosed patient\n* Patients must provide written informed consent to participate in the study\n* Anticipated initiation of cetuximab treatment with or without additional chemotherapy.\n* Able to self-administer topical interventions or provide for another person to apply the topical interventions\n\nExclusion Criteria:\n\n* Females of childbearing potential who are pregnant or nursing\n* Patients with allergy, hypersensitivity or other contraindication to dapsone, sulfa antibiotics, or excipients of the dapsone gel product\n* Patients with pre-existing dermatologic condition affecting the face and chest that would impair assessment of papulopustular rash including dense and/or long facial hair (per investigator discretion)\n* Patients currently using prescription and/or over-the-counter topical medications to the face and/or chest who are unwilling to discontinue use during the trial intervention period (day 0 ± 2 days through day 28 ± 2 days)\n* Previous or concurrent radiation therapy to head, neck, and chest (i.e. application sites only)\n* Previous therapy with cetuximab within 6 months of consent'}, 'identificationModule': {'nctId': 'NCT01931150', 'briefTitle': 'Study of Prophylactic Topical Dapsone 5% Gel Versus Moisturizer for Cetuximab-induced Papulopustular (Acneiform) Rash in Patients With mCRC or HNSCC Without Previous or Concurrent RT', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'A Phase III Randomized Double-blind Study of Prophylactic Topical Dapsone 5% Gel Versus Moisturizer for Cetuximab-induced Papulopustular (Acneiform) Rash in Patients With mCRC or HNSCC Without Previous or Concurrent RT', 'orgStudyIdInfo': {'id': '13-012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dapsone LEFT, Moisturizer RIGHT', 'description': 'Dapsone 5% gel to LEFT side of face and chest BID (morning and evening) Moisturizer to RIGHT side of face and chest BID (morning and evening) AND oral antibiotics (doxycycline 100 mg bid OR minocycline 100 mg once daily or other antibiotic daily)', 'interventionNames': ['Drug: Topical Dapsone 5% Gel', 'Other: Moisturizer', 'Drug: oral antibiotics']}, {'type': 'EXPERIMENTAL', 'label': 'Dapsone RIGHT, Moisturizer LEFT', 'description': 'Moisturizer to LEFT side of face and chest BID (morning and evening) Dapsone 5% gel to RIGHT side of face and chest BID (morning and evening) AND oral antibiotics (doxycycline 100 mg bid OR minocycline 100 mg once daily or other antibiotic daily)', 'interventionNames': ['Drug: Topical Dapsone 5% Gel', 'Other: Moisturizer', 'Drug: oral antibiotics']}], 'interventions': [{'name': 'Topical Dapsone 5% Gel', 'type': 'DRUG', 'armGroupLabels': ['Dapsone LEFT, Moisturizer RIGHT', 'Dapsone RIGHT, Moisturizer LEFT']}, {'name': 'Moisturizer', 'type': 'OTHER', 'description': 'The moisturizer for the study will be Vanicream™ Lite Lotion.', 'armGroupLabels': ['Dapsone LEFT, Moisturizer RIGHT', 'Dapsone RIGHT, Moisturizer LEFT']}, {'name': 'oral antibiotics', 'type': 'DRUG', 'armGroupLabels': ['Dapsone LEFT, Moisturizer RIGHT', 'Dapsone RIGHT, Moisturizer LEFT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Mario Lacouture, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}