Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2026-01-26 @ 12:21 AM
Study NCT ID:
NCT03559218
Status:
COMPLETED
Last Update Posted:
2021-09-09
First Post:
2018-03-19
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
KeraStat(R) Cream for Radiation Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2020-09-14', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D011855', 'term': 'Radiodermatitis'}], 'ancestors': [{'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D011832', 'term': 'Radiation Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rclohessy@keranetics.com', 'phone': '4102513940', 'title': 'Ryan Clohessy, PhD', 'organization': 'KeraNetics'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Subjects were monitored throughout the course of radiation therapy (4-6 weeks) with a 4-week follow-up visit.', 'description': 'All SAEs should be reported to the study sponsor within 24 hours of the investigator being aware of the event and reported to the IRB in accordance with IRB requirements.', 'eventGroups': [{'id': 'EG000', 'title': 'Standard of Care', 'description': 'Patients undergoing radiation therapy for breast cancer will be provided instructions for radiation dermatitis per institutional standard of care\n\nStandard of care: Patients will be instructed to follow institutional standard of care for radiation dermatitis', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'KeraStat Cream', 'description': 'Patients undergoing radiation therapy for breast cancer will be provided KeraStat Cream for twice daily application.\n\nKeraStat(R) Cream: KeraStat Cream is a cream wound dressing that contains 5% keratin.', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Radiation Therapy Oncology Group Skin Toxicity Scoring', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care', 'description': 'Patients undergoing radiation therapy for breast cancer will be provided instructions for radiation dermatitis per institutional standard of care\n\nStandard of care: Patients will be instructed to follow institutional standard of care for radiation dermatitis'}, {'id': 'OG001', 'title': 'KeraStat Cream', 'description': 'Patients undergoing radiation therapy for breast cancer will be provided KeraStat Cream for twice daily application.\n\nKeraStat(R) Cream: KeraStat Cream is a cream wound dressing that contains 5% keratin.'}], 'classes': [{'title': 'Visit 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Visit 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.09', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '0.15', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1'}]}]}, {'title': 'Visit 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.55', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '0.62', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1'}]}]}, {'title': 'Visit 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.82', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '1.00', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2'}]}]}, {'title': 'Visit 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '1.17', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2'}]}]}, {'title': 'Visit 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.36', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '1.00', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1'}]}]}, {'title': 'Visit 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.30', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '0.23', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Visit 1), Weekly Visits throughout RT (Visits 2-6), Final Visit approximately 6 weeks post-RT (Visit 7). Subject study duration 8-12 weeks.', 'description': 'The RTOG will be used to track skin reactions to radiation therapy. No toxicity is considered a 0, while massive toxicity is considered a 4. Data will be aggregated across groups at each time point.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'One subject missed visit 5. One subject missed visit 6. Subject #18 missed visit 7.'}, {'type': 'PRIMARY', 'title': 'Dermatology Life Quality Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care', 'description': 'Patients undergoing radiation therapy for breast cancer will be provided instructions for radiation dermatitis per institutional standard of care\n\nStandard of care: Patients will be instructed to follow institutional standard of care for radiation dermatitis'}, {'id': 'OG001', 'title': 'KeraStat Cream', 'description': 'Patients undergoing radiation therapy for breast cancer will be provided KeraStat Cream for twice daily application.\n\nKeraStat(R) Cream: KeraStat Cream is a cream wound dressing that contains 5% keratin.'}], 'classes': [{'title': 'Visit 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.73', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '18'}, {'value': '0.31', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '3'}]}]}, {'title': 'Visit 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.64', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '6'}, {'value': '0.77', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '5'}]}]}, {'title': 'Visit 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.91', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '7'}, {'value': '2.23', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '15'}]}]}, {'title': 'Visit 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.36', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '7'}, {'value': '2.85', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '11'}]}]}, {'title': 'Visit 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.27', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '15'}, {'value': '4.75', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '26'}]}]}, {'title': 'Visit 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.18', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '17'}, {'value': '4.25', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '14'}]}]}, {'title': 'Visit 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '6'}, {'value': '0.85', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '4'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Visit 1), Weekly Visits throughout RT (Visits 2-6), Final Visit approximately 6 weeks post-RT (Visit 7). Subject study duration 8-12 weeks.', 'description': "The DLQI measures the impact of dermatological conditions on a patient's quality of life. The DLQI is scored by summing the score of each question (answered from not at all, 0, to very much, 3). The maximum is 30 and the minimum is 0. The higher the score, the greater the impairment of quality of life. Data will be aggregated across treatment groups.", 'unitOfMeasure': 'units on a scale (DQLI score)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'One subject missed visit 5. One subject missed visit 6. Subject #18 missed visit 7.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care', 'description': 'Patients undergoing radiation therapy for breast cancer will be provided instructions for radiation dermatitis per institutional standard of care\n\nStandard of care: Patients will be instructed to follow institutional standard of care for radiation dermatitis'}, {'id': 'OG001', 'title': 'KeraStat Cream', 'description': 'Patients undergoing radiation therapy for breast cancer will be provided KeraStat Cream for twice daily application.\n\nKeraStat(R) Cream: KeraStat Cream is a cream wound dressing that contains 5% keratin.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (Visit 1), Weekly Visits throughout RT (Visits 2-6), Final Visit approximately 6 weeks post-RT (Visit 7). Subject study duration 8-12 weeks.', 'description': 'Evaluate safety and tolerability of application of KeraStat Cream through comparison of adverse events reported in KeraStat Cream group versus standard of care.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard of Care', 'description': 'Patients undergoing radiation therapy for breast cancer will be provided instructions for radiation dermatitis per institutional standard of care\n\nStandard of care: Patients will be instructed to follow institutional standard of care for radiation dermatitis'}, {'id': 'FG001', 'title': 'KeraStat Cream', 'description': 'Patients undergoing radiation therapy for breast cancer will be provided KeraStat Cream for twice daily application.\n\nKeraStat(R) Cream: KeraStat Cream is a cream wound dressing that contains 5% keratin.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard of Care', 'description': 'Patients undergoing radiation therapy for breast cancer will be provided instructions for radiation dermatitis per institutional standard of care\n\nStandard of care: Patients will be instructed to follow institutional standard of care for radiation dermatitis'}, {'id': 'BG001', 'title': 'KeraStat Cream', 'description': 'Patients undergoing radiation therapy for breast cancer will be provided KeraStat Cream for twice daily application.\n\nKeraStat(R) Cream: KeraStat Cream is a cream wound dressing that contains 5% keratin.'}, {'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': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'One subject withdrew at baseline prior to treatment and was not included.'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.4', 'spread': '7.5', 'groupId': 'BG000'}, {'value': '59.2', 'spread': '9.9', 'groupId': 'BG001'}, {'value': '62.0', 'spread': '9.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Radiation Therapy Oncology Group Skin Toxicity Grade (RTOG)', 'classes': [{'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'BG000'}, {'value': '0', 'spread': '0', 'groupId': 'BG001'}, {'value': '0', 'spread': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'RTOG as assessed by physician: Grade 0 (no toxicity) to Grade 4 (\n\nNote expectation is that there would be no skin toxicity at the start of the study, so a baseline of "0" is the expected value.\n\nIncreasing pathology is reflected in the higher grades.', 'unitOfMeasure': 'units on a scale (RTOG)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Dermatology Life Quality Index', 'classes': [{'categories': [{'measurements': [{'value': '2.73', 'spread': '5.12', 'groupId': 'BG000'}, {'value': '0.31', 'spread': '0.85', 'groupId': 'BG001'}, {'value': '1.42', 'spread': '3.89', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "This scale measures the impact of skin conditions on a participant's quality of life. The DLQI is calculated by adding the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. A score higher than 10 indicates that the patient's life is being severely affected by their skin disease.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Baseline RTOG score and DQLI score, as assessed by physician.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-03-01', 'size': 14012033, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-08-24T11:05', 'hasProtocol': True}, {'date': '2019-07-10', 'size': 425236, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-08-24T11:31', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2018-11-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-05', 'studyFirstSubmitDate': '2018-03-19', 'resultsFirstSubmitDate': '2020-08-24', 'studyFirstSubmitQcDate': '2018-06-05', 'lastUpdatePostDateStruct': {'date': '2021-09-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-09-05', 'studyFirstPostDateStruct': {'date': '2018-06-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-09-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radiation Therapy Oncology Group Skin Toxicity Scoring', 'timeFrame': 'Baseline (Visit 1), Weekly Visits throughout RT (Visits 2-6), Final Visit approximately 6 weeks post-RT (Visit 7). Subject study duration 8-12 weeks.', 'description': 'The RTOG will be used to track skin reactions to radiation therapy. No toxicity is considered a 0, while massive toxicity is considered a 4. Data will be aggregated across groups at each time point.'}, {'measure': 'Dermatology Life Quality Index', 'timeFrame': 'Baseline (Visit 1), Weekly Visits throughout RT (Visits 2-6), Final Visit approximately 6 weeks post-RT (Visit 7). Subject study duration 8-12 weeks.', 'description': "The DLQI measures the impact of dermatological conditions on a patient's quality of life. The DLQI is scored by summing the score of each question (answered from not at all, 0, to very much, 3). The maximum is 30 and the minimum is 0. The higher the score, the greater the impairment of quality of life. Data will be aggregated across treatment groups."}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Adverse Events', 'timeFrame': 'Baseline (Visit 1), Weekly Visits throughout RT (Visits 2-6), Final Visit approximately 6 weeks post-RT (Visit 7). Subject study duration 8-12 weeks.', 'description': 'Evaluate safety and tolerability of application of KeraStat Cream through comparison of adverse events reported in KeraStat Cream group versus standard of care.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Radiation Dermatitis']}, 'descriptionModule': {'briefSummary': 'The primary objectives of the proposed research are to evaluate patient use of KeraStat Cream and collect data to inform a larger future trial.', 'detailedDescription': 'The primary objectives of the proposed research are to evaluate patient use of KeraStat Cream and collect data to inform a larger future trial.\n\nThe secondary objectives are to assess the safety and tolerability of KeraStat Cream in subjects at risk of radiation dermatitis, to assess the effectiveness of KeraStat Cream and how that compares to the current standard of care, and to estimate the amount of KeraStat Cream used per patient and coverage on skin.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18 to 70\n2. Female\n3. Diagnosis of breast cancer and scheduled to receive 4 to 6 weeks of radiation therapy (radiation dose of 42 Gy or more)\n4. Able and willing to sign protocol consent form\n5. Able and willing to document symptoms and treatment details as often as needed, not to exceed daily notes\n6. Able and willing to have photographs of the affected area taken regularly\n\nExclusion Criteria:\n\n1. Women who are pregnant, lactating/nursing or plan to become pregnant\n2. Previous radiation therapy to the area to be treated with radiation therapy\n3. Receiving palliative radiation therapy\n4. Unhealed or infected surgical sites in the irradiation area\n5. Patients undergoing cytotoxic chemotherapy or concurrent Herceptin as part of overall treatment plan (tamoxifen/aromatase inhibitor allowed)\n6. Use of oral corticosteroids or topical corticosteroids in the irradiation area\n7. Autoimmune disease\n8. Skin disease in target irradiation area\n9. Known allergy to the standard of care or ingredients in KeraStat Cream'}, 'identificationModule': {'nctId': 'NCT03559218', 'briefTitle': 'KeraStat(R) Cream for Radiation Dermatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'KeraNetics, LLC'}, 'officialTitle': 'Pilot Study: KeraStat(R) Cream for Radiation Dermatitis', 'orgStudyIdInfo': {'id': 'KSCM-CRD-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Standard of care', 'description': 'Patients undergoing radiation therapy for breast cancer will be provided instructions for radiation dermatitis per institutional standard of care', 'interventionNames': ['Other: Standard of care']}, {'type': 'EXPERIMENTAL', 'label': 'KeraStat Cream', 'description': 'Patients undergoing radiation therapy for breast cancer will be provided KeraStat Cream for twice daily application.', 'interventionNames': ['Device: KeraStat(R) Cream']}], 'interventions': [{'name': 'KeraStat(R) Cream', 'type': 'DEVICE', 'description': 'KeraStat Cream is a cream wound dressing that contains 5% keratin.', 'armGroupLabels': ['KeraStat Cream']}, {'name': 'Standard of care', 'type': 'OTHER', 'description': 'Patients will be instructed to follow institutional standard of care for radiation dermatitis', 'armGroupLabels': ['Standard of care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest School of Medicine', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'Karen Winfield, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'KeraNetics, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}