Ignite Creation Date:
2025-12-24 @ 1:48 PM
Ignite Modification Date:
2025-12-30 @ 12:27 AM
Study NCT ID:
NCT03374995
Status:
COMPLETED
Last Update Posted:
2024-06-11
First Post:
2017-11-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Topical Keratin in Treating Radiation Dermatitis in Patients With Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D011855', 'term': 'Radiodermatitis'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D011832', 'term': 'Radiation Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017410', 'term': 'Practice Guidelines as Topic'}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D017408', 'term': 'Guidelines as Topic'}, {'id': 'D011785', 'term': 'Quality Assurance, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D019984', 'term': 'Quality Indicators, Health Care'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kwinkfie@wakehealth.edu', 'phone': '336-716-5440', 'title': 'Principal investigator', 'organization': 'Wake Forest University Health Sciences'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 30 days post radiation therapy', 'description': 'Expected side effects of radiation therapy that occurred at expected timeframes and severity (e.g., erythema, edema, desquamation) were not considered to be adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'Group I (Topical Keratin)', 'description': 'Patients receive topical keratin topically at least BID until the end of radiation therapy (approximately 3-6 weeks).\n\nQuality-of-Life Assessment: Ancillary studies\n\nTopical Keratin: Given topically', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group II (Standard of Care)', 'description': 'Patients receive standard of care as directed by radiation oncologist until the end of radiation therapy (approximately 3-6 weeks).\n\nBest Practice: Receive standard of care\n\nQuality-of-Life Assessment: Ancillary studies', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of Early Adverse Skin Reactions (EASRs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group I (Topical Keratin)', 'description': 'Patients receive topical keratin topically at least BID until the end of radiation therapy (approximately 3-6 weeks).\n\nQuality-of-Life Assessment: Ancillary studies\n\nTopical Keratin: Given topically'}, {'id': 'OG001', 'title': 'Group II (Standard of Care)', 'description': 'Patients receive standard of care as directed by radiation oncologist until the end of radiation therapy (approximately 3-6 weeks).\n\nBest Practice: Receive standard of care\n\nQuality-of-Life Assessment: Ancillary studies'}], 'classes': [{'title': 'Grade I Acute Radiation Dermatitis', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Grade II Acute Radiation Dermatitis', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Moist Desquamation', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 4 weeks post-RT', 'description': 'The Modified ONS Criteria for Radiation-Induced Acute Skin Toxicity will be used for classification of EASRs related to the skin. Participants will report in a total of 7 visits any experience with Grade I (faint or dull erythema; dry desquamation or Grade II (tender or bright erythema, patchy, moist desquamation) acute radiation dermatitis using the RTOG (Radiation Therapy Oncology Group) grading system with Grade II considered the worse outcome. Comparative effectiveness will include the number or study participants in each arm that experience RTOG Grade I or Grade II radiation dermatitis and moist desquamation.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group I (Topical Keratin)', 'description': 'Patients receive topical keratin topically at least BID until the end of radiation therapy (approximately 3-6 weeks).\n\nQuality-of-Life Assessment: Ancillary studies\n\nTopical Keratin: Given topically'}, {'id': 'OG001', 'title': 'Group II (Standard of Care)', 'description': 'Patients receive standard of care as directed by radiation oncologist until the end of radiation therapy (approximately 3-6 weeks).\n\nBest Practice: Receive standard of care\n\nQuality-of-Life Assessment: Ancillary studies'}], 'classes': [{'title': 'Visit 1 (baseline)', 'categories': [{'measurements': [{'value': '0.31', 'spread': '0.82', 'groupId': 'OG000'}, {'value': '2.73', 'spread': '5.26', 'groupId': 'OG001'}]}]}, {'title': 'Visit 2', 'categories': [{'measurements': [{'value': '0.77', 'spread': '1.31', 'groupId': 'OG000'}, {'value': '1.64', 'spread': '2.06', 'groupId': 'OG001'}]}]}, {'title': 'Visit 3', 'categories': [{'measurements': [{'value': '2.23', 'spread': '3.85', 'groupId': 'OG000'}, {'value': '1.91', 'spread': '2.11', 'groupId': 'OG001'}]}]}, {'title': 'Visit 4', 'categories': [{'measurements': [{'value': '2.85', 'spread': '2.98', 'groupId': 'OG000'}, {'value': '2.36', 'spread': '2.53', 'groupId': 'OG001'}]}]}, {'title': 'Visit 5', 'categories': [{'measurements': [{'value': '4.75', 'spread': '6.99', 'groupId': 'OG000'}, {'value': '5.27', 'spread': '5.01', 'groupId': 'OG001'}]}]}, {'title': 'Visit 6', 'categories': [{'measurements': [{'value': '4.25', 'spread': '4.87', 'groupId': 'OG000'}, {'value': '6.18', 'spread': '5.70', 'groupId': 'OG001'}]}]}, {'title': 'Visit 7', 'categories': [{'measurements': [{'value': '0.85', 'spread': '1.10', 'groupId': 'OG000'}, {'value': '1.00', 'spread': '2.05', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to up to 7 weeks', 'description': "A 10-item assessment completed at each visit (7 total) to measure participant's Dermatology Life Quality Index. Score range is 0-3 (very much = 3; a lot = 2; a little = 1; and not at all or not relevant = 0) Maximum score of 30. The higher the score the more qualify of life is impaired. The average DQLI score at each study visit will be compared between the KeraStat® Cream arm and the SOC arm as a study effectiveness measure.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Physician Observed Improvement in Skin Appearance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group I (Topical Keratin)', 'description': 'Patients receive topical keratin topically at least BID until the end of radiation therapy (approximately 3-6 weeks).\n\nQuality-of-Life Assessment: Ancillary studies\n\nTopical Keratin: Given topically'}, {'id': 'OG001', 'title': 'Group II (Standard of Care)', 'description': 'Patients receive standard of care as directed by radiation oncologist until the end of radiation therapy (approximately 3-6 weeks).\n\nBest Practice: Receive standard of care\n\nQuality-of-Life Assessment: Ancillary studies'}], 'classes': [{'title': 'Visit 1 (baseline)', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Visit 2', 'categories': [{'measurements': [{'value': '0.15', 'spread': '0.36', 'groupId': 'OG000'}, {'value': '0.09', 'spread': '0.29', 'groupId': 'OG001'}]}]}, {'title': 'Visit 3', 'categories': [{'measurements': [{'value': '0.62', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '0.55', 'spread': '0.50', 'groupId': 'OG001'}]}]}, {'title': 'Visit 4', 'categories': [{'measurements': [{'value': '1.00', 'spread': '0.68', 'groupId': 'OG000'}, {'value': '0.82', 'spread': '0.38', 'groupId': 'OG001'}]}]}, {'title': 'Visit 5', 'categories': [{'measurements': [{'value': '1.17', 'spread': '0.55', 'groupId': 'OG000'}, {'value': '1.00', 'spread': '0.43', 'groupId': 'OG001'}]}]}, {'title': 'Visit 6', 'categories': [{'measurements': [{'value': '1.00', 'spread': '0', 'groupId': 'OG000'}, {'value': '1.36', 'spread': '0.64', 'groupId': 'OG001'}]}]}, {'title': 'Visit 7', 'categories': [{'measurements': [{'value': '0.23', 'spread': '0.42', 'groupId': 'OG000'}, {'value': '0.30', 'spread': '0.46', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to up to 7 weeks', 'description': 'Skin appearance was assessed by the treating physician at each visit (total of 7) using the Radiation Therapy Oncology Group (RTOG) Toxicity scale Grade 1 and Grade 2 assessed only. Score = (Grade 1 (follicular, faint or dull erythema, dry desquamation and Grade 2 (tender or bright erythema, patchy, ,moist desquamation) with Grade 2 being the worst for this study. Scores range from 0 to 2, with higher values being the worst. The average RTOG score at each study visit will be compared between the KeraStat® Cream arm and the SOC arm as a study effectiveness measure.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants Reported Change in Skin Appearance Using the Dermatology Quality of Life Index Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group I (Topical Keratin)', 'description': 'Patients receive topical keratin topically at least BID until the end of radiation therapy (approximately 3-6 weeks).\n\nQuality-of-Life Assessment: Ancillary studies\n\nTopical Keratin: Given topically'}, {'id': 'OG001', 'title': 'Group II (Standard of Care)', 'description': 'Patients receive standard of care as directed by radiation oncologist until the end of radiation therapy (approximately 3-6 weeks).\n\nBest Practice: Receive standard of care\n\nQuality-of-Life Assessment: Ancillary studies'}], 'classes': [{'title': 'Visit 1 (baseline)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Visit 2', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Visit 3', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Visit 4', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Visit 5', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Visit 6', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Visit 7', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to up to 7 weeks', 'description': "Change in skin appearance by the participants' self-report using the Dermatology Quality of Life Index (DLQI) was used to assess skin after completion of radiation. Score range is 0-3 (very much = 3; a lot = 2; a little = 1; and not at all or not relevant = 0) Maximum score of 30. A higher score shows better performance/improvement in skin appearance. The average Dermatology Qualify of Life Index score each study visit will be compared between the two arms with the number of participants reporting a score.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group I (Topical Keratin)', 'description': 'Patients receive topical keratin topically at least BID until the end of radiation therapy (approximately 3-6 weeks).\n\nQuality-of-Life Assessment: Ancillary studies\n\nTopical Keratin: Given topically'}, {'id': 'FG001', 'title': 'Group II (Standard of Care)', 'description': 'Patients receive standard of care as directed by radiation oncologist until the end of radiation therapy (approximately 3-6 weeks).\n\nBest Practice: Receive standard of care\n\nQuality-of-Life Assessment: Ancillary studies'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Group I (Topical Keratin)', 'description': 'Patients receive topical keratin topically at least BID until the end of radiation therapy (approximately 3-6 weeks).\n\nQuality-of-Life Assessment: Ancillary studies\n\nTopical Keratin: Given topically'}, {'id': 'BG001', 'title': 'Group II (Standard of Care)', 'description': 'Patients receive standard of care as directed by radiation oncologist until the end of radiation therapy (approximately 3-6 weeks).\n\nBest Practice: Receive standard of care\n\nQuality-of-Life Assessment: Ancillary studies'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.15', 'spread': '9.5', 'groupId': 'BG000'}, {'value': '65.36', 'spread': '7.18', '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': '13', 'groupId': 'BG000'}, {'value': '11', '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': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '24', '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': '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': '1', 'groupId': 'BG000'}, {'value': '0', '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': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', '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': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-03-01', 'size': 1363880, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-11-26T16:00', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-29', 'studyFirstSubmitDate': '2017-11-29', 'resultsFirstSubmitDate': '2019-11-26', 'studyFirstSubmitQcDate': '2017-12-14', 'lastUpdatePostDateStruct': {'date': '2024-06-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-01-31', 'studyFirstPostDateStruct': {'date': '2017-12-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Early Adverse Skin Reactions (EASRs)', 'timeFrame': 'Up to 4 weeks post-RT', 'description': 'The Modified ONS Criteria for Radiation-Induced Acute Skin Toxicity will be used for classification of EASRs related to the skin. Participants will report in a total of 7 visits any experience with Grade I (faint or dull erythema; dry desquamation or Grade II (tender or bright erythema, patchy, moist desquamation) acute radiation dermatitis using the RTOG (Radiation Therapy Oncology Group) grading system with Grade II considered the worse outcome. Comparative effectiveness will include the number or study participants in each arm that experience RTOG Grade I or Grade II radiation dermatitis and moist desquamation.'}, {'measure': 'Change in Quality of Life', 'timeFrame': 'Baseline to up to 7 weeks', 'description': "A 10-item assessment completed at each visit (7 total) to measure participant's Dermatology Life Quality Index. Score range is 0-3 (very much = 3; a lot = 2; a little = 1; and not at all or not relevant = 0) Maximum score of 30. The higher the score the more qualify of life is impaired. The average DQLI score at each study visit will be compared between the KeraStat® Cream arm and the SOC arm as a study effectiveness measure."}, {'measure': 'Physician Observed Improvement in Skin Appearance', 'timeFrame': 'Baseline to up to 7 weeks', 'description': 'Skin appearance was assessed by the treating physician at each visit (total of 7) using the Radiation Therapy Oncology Group (RTOG) Toxicity scale Grade 1 and Grade 2 assessed only. Score = (Grade 1 (follicular, faint or dull erythema, dry desquamation and Grade 2 (tender or bright erythema, patchy, ,moist desquamation) with Grade 2 being the worst for this study. Scores range from 0 to 2, with higher values being the worst. The average RTOG score at each study visit will be compared between the KeraStat® Cream arm and the SOC arm as a study effectiveness measure.'}, {'measure': 'Number of Participants Reported Change in Skin Appearance Using the Dermatology Quality of Life Index Scale', 'timeFrame': 'Baseline to up to 7 weeks', 'description': "Change in skin appearance by the participants' self-report using the Dermatology Quality of Life Index (DLQI) was used to assess skin after completion of radiation. Score range is 0-3 (very much = 3; a lot = 2; a little = 1; and not at all or not relevant = 0) Maximum score of 30. A higher score shows better performance/improvement in skin appearance. The average Dermatology Qualify of Life Index score each study visit will be compared between the two arms with the number of participants reporting a score."}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Breast Carcinoma', 'Radiation-Induced Dermatitis']}, 'descriptionModule': {'briefSummary': 'This randomized pilot clinical trial studies how well topical keratin works in treating radiation dermatitis in patients with breast cancer. Radiation dermatitis is a skin condition that is a common side effect of radiation therapy. The affected skin becomes painful, red, itchy, and blistered. Topical keratin may help to improve skin appearance and hydration in patients with breast cancer.', 'detailedDescription': "PRIMARY OBJECTIVES:\n\nI. To determine a preliminary estimate of the improvement of skin's natural barrier, decrease of dehydration, and reduction in the appearance of inflammation associated with radiation therapy (RT) skin toxicity as well as patients' satisfaction with their skin after the application of the medical device topical keratin (KeraStat Cream) during RT in breast cancer patients.\n\nOUTLINE: Patients are randomized to 1 of 2 groups.\n\nGROUP I: Patients receive topical keratin topically at least twice daily (BID) until the end of radiation therapy (approximately 3-6 weeks).\n\nGROUP II: Patients receive standard of care as directed by radiation oncologist until the end of radiation therapy (approximately 3-6 weeks).\n\nAfter completion of study treatment, patients are followed up at 4-6 weeks."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of breast cancer, received chemotherapy, and scheduled to receive 4 to 6 weeks of radiation therapy (radiation protocol of 42 Gy+)\n* Area to be irradiated representing 1-10% of total body surface area (TBSA)\n* Able and willing to sign protocol consent form\n* Able and willing to document symptoms and treatment details as often as needed, not to exceed daily notes\n* Able and willing to have photographs of the affected area taken regularly\n\nExclusion Criteria:\n\n* Women who are pregnant, lactating/nursing or plan to become pregnant\n* Previous radiation therapy to the area to be treated with radiation therapy\n* Receiving palliative radiation therapy\n* Unhealed or infected surgical sites in the irradiation area\n* Patients undergoing cytotoxic chemotherapy or concurrent Herceptin as part of overall treatment plan (tamoxifen/aromatase inhibitor allowed)\n* Use of oral corticosteroids or topical corticosteroids in the irradiation area\n* Use of Erbitux\n* Autoimmune disease\n* Skin disease in target irradiation area\n* Smoker\n* Known allergy to the standard of care or ingredients in KeraStat Cream'}, 'identificationModule': {'nctId': 'NCT03374995', 'briefTitle': 'Topical Keratin in Treating Radiation Dermatitis in Patients With Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Pilot Study: KeraStat Cream for Radiation Dermatitis', 'orgStudyIdInfo': {'id': 'IRB00046759'}, 'secondaryIdInfos': [{'id': 'NCI-2017-02011', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'CCCWFU 97417', 'type': 'OTHER', 'domain': 'Comprehensive Cancer Center of Wake Forest University'}, {'id': 'P30CA012197', 'link': 'https://reporter.nih.gov/quickSearch/P30CA012197', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group I (topical keratin)', 'description': 'Patients receive topical keratin topically at least BID until the end of radiation therapy (approximately 3-6 weeks).', 'interventionNames': ['Other: Quality-of-Life Assessment', 'Device: Topical Keratin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group II (standard of care)', 'description': 'Patients receive standard of care as directed by radiation oncologist until the end of radiation therapy (approximately 3-6 weeks).', 'interventionNames': ['Other: Best Practice', 'Other: Quality-of-Life Assessment']}], 'interventions': [{'name': 'Best Practice', 'type': 'OTHER', 'otherNames': ['standard of care', 'standard therapy'], 'description': 'Receive standard of care', 'armGroupLabels': ['Group II (standard of care)']}, {'name': 'Quality-of-Life Assessment', 'type': 'OTHER', 'otherNames': ['Quality of Life Assessment'], 'description': 'Ancillary studies', 'armGroupLabels': ['Group I (topical keratin)', 'Group II (standard of care)']}, {'name': 'Topical Keratin', 'type': 'DEVICE', 'otherNames': ['KeraStat'], 'description': 'Given topically', 'armGroupLabels': ['Group I (topical keratin)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Comprehensive Cancer Center of Wake Forest University', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'Karen Winkfield', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}