Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-25 @ 9:21 PM
Study NCT ID:
NCT04483856
Status:
COMPLETED
Last Update Posted:
2025-05-15
First Post:
2020-07-13
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Efficacy and Tolerability Evaluation of a Topical MD Based on SHBF in Management of Radiodermatitis.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lfabbri@relifecompany.it', 'phone': '05556809528', 'title': 'Clinical Trials Coordinator', 'organization': 'Relife Srl'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'up to 1 year', 'description': 'the adverse events are not related to the treatment performed.', 'eventGroups': [{'id': 'EG000', 'title': 'DermoRelizema Cream', 'description': "The treatment will be applied since about 7 (±3) days prior to RT start and will continue until 14 days post RT end\n\nDermoRelizema cream: Fingertip units (FTU) depending from the extent of the affected skin to treat, two times per day for 7 (±3) days prior RT until about 14 (±3) days post RT end. The product can be used for further 2 weeks (from V3 to V4) in case of need, according to the investigator's judgment", 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 0, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Dexeryl', 'description': 'The treatment will be applied since 7 (±3) days prior to RT start and will continue until 14 days post RT end (98-112 applications in total).\n\nDexeryl: FTUs depending on the extent of the affected skin to treat, two times per day. The treatment will be applied since 7 (±3) days prior to RT start and will continue until 14 days post RT end (98-112 applications in total).', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 0, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Progression of Radio Therapy Induced Skin Reaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DermoRelizema Cream', 'description': "The treatment will be applied since about 7 (±3) days prior to RT start and will continue until 14 days post RT end\n\nDermoRelizema cream: Fingertip units (FTU) depending from the extent of the affected skin to treat, two times per day for 7 (±3) days prior RT until about 14 (±3) days post RT end. The product can be used for further 2 weeks (from V3 to V4) in case of need, according to the investigator's judgment"}, {'id': 'OG001', 'title': 'Dexeryl', 'description': 'The treatment will be applied since 7 (±3) days prior to RT start and will continue until 14 days post RT end (98-112 applications in total).\n\nDexeryl: FTUs depending on the extent of the affected skin to treat, two times per day. The treatment will be applied since 7 (±3) days prior to RT start and will continue until 14 days post RT end (98-112 applications in total).'}], 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'two weeks after the last RT sessiont,day 35-42', 'description': 'Evaluation of the effects of DermoRelizemaTM cream in the management of the progression of RT-induced skin reactions and toxicity', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Progression of Radio Therapy-induced Skin Reactions Using the Grading System of the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/ EORTC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DermoRelizema Cream', 'description': "The treatment will be applied since about 7 (±3) days prior to RT start and will continue until 14 days post RT end\n\nDermoRelizema cream: Fingertip units (FTU) depending from the extent of the affected skin to treat, two times per day for 7 (±3) days prior RT until about 14 (±3) days post RT end. The product can be used for further 2 weeks (from V3 to V4) in case of need, according to the investigator's judgment"}, {'id': 'OG001', 'title': 'Dexeryl', 'description': 'The treatment will be applied since 7 (±3) days prior to RT start and will continue until 14 days post RT end (98-112 applications in total).\n\nDexeryl: FTUs depending on the extent of the affected skin to treat, two times per day. The treatment will be applied since 7 (±3) days prior to RT start and will continue until 14 days post RT end (98-112 applications in total).'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at the conclusion of the radiotherapy treatment, day 21-28 and at the study end day 49-56, reported day 56', 'description': '1\\. Evaluation of the effects of DermoRelizemaTM cream, in the management of the progression of RT-induced skin reactions and toxicity, using the (RTOG/ EORTC) at the conclusion of the radiotherapy treatment (V2) and at study end (V4)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Evaluation of the Radiation Symptoms (0 Best Result, 40 Worst Results)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DermoRelizema Cream', 'description': "The treatment will be applied since about 7 (±3) days prior to RT start and will continue until 14 days post RT end\n\nDermoRelizema cream: Fingertip units (FTU) depending from the extent of the affected skin to treat, two times per day for 7 (±3) days prior RT until about 14 (±3) days post RT end. The product can be used for further 2 weeks (from V3 to V4) in case of need, according to the investigator's judgment"}, {'id': 'OG001', 'title': 'Dexeryl', 'description': 'The treatment will be applied since 7 (±3) days prior to RT start and will continue until 14 days post RT end (98-112 applications in total).\n\nDexeryl: FTUs depending on the extent of the affected skin to treat, two times per day. The treatment will be applied since 7 (±3) days prior to RT start and will continue until 14 days post RT end (98-112 applications in total).'}], 'classes': [{'title': 'pain', 'categories': [{'measurements': [{'value': '15.56', 'spread': '15.58', 'groupId': 'OG000'}, {'value': '17.90', 'spread': '14.05', 'groupId': 'OG001'}]}]}, {'title': 'itch', 'categories': [{'measurements': [{'value': '14.42', 'spread': '10.29', 'groupId': 'OG000'}, {'value': '15.79', 'spread': '10.81', 'groupId': 'OG001'}]}]}, {'title': 'burning', 'categories': [{'measurements': [{'value': '15.53', 'spread': '11.97', 'groupId': 'OG000'}, {'value': '12.65', 'spread': '10.21', 'groupId': 'OG001'}]}]}, {'title': 'tenderness', 'categories': [{'measurements': [{'value': '8', 'spread': '9.28', 'groupId': 'OG000'}, {'value': '12.96', 'spread': '9.58', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 1 year', 'description': 'Evaluation of dermatitis symptoms management', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of patients that are better on the radiation symptoms reported by the patient in a diary'}, {'type': 'SECONDARY', 'title': 'Severity of Radio Therapy-induced Skin Reactions Using the Grading System of the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/ EORTC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DermoRelizema Cream', 'description': "The treatment will be applied since about 7 (±3) days prior to RT start and will continue until 14 days post RT end\n\nDermoRelizema cream: Fingertip units (FTU) depending from the extent of the affected skin to treat, two times per day for 7 (±3) days prior RT until about 14 (±3) days post RT end. The product can be used for further 2 weeks (from V3 to V4) in case of need, according to the investigator's judgment"}, {'id': 'OG001', 'title': 'Dexeryl', 'description': 'The treatment will be applied since 7 (±3) days prior to RT start and will continue until 14 days post RT end (98-112 applications in total).\n\nDexeryl: FTUs depending on the extent of the affected skin to treat, two times per day. The treatment will be applied since 7 (±3) days prior to RT start and will continue until 14 days post RT end (98-112 applications in total).'}], 'classes': [{'title': 'V2 no erythema', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'V2 erythema grade 1', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'V2 erythema grade 2', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'V2 erythema grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'V3 no erythema', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'V3 erythema grade 1', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'V3 erythema grade 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'V4 no erythema', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'V4 erythema grade1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'all study visits, day 21-28, day 35-42 and at the study end (day 49-56)', 'description': 'Evaluation of the severity of radiation dermatitis by the investigator using the RTOG/ EORTC (system of the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer(grade 0-1: treatment is succesfull, grade 1 or magior: treatment insuccesful) ), at visits 2, 3 and 4', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluation of the severity of radiation dermatitis by the investigator'}, {'type': 'SECONDARY', 'title': 'Severity of Radiation Dermatitis With Radiation Dermatitis Severity (RDS) Scoring Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DermoRelizema Cream', 'description': "The treatment will be applied since about 7 (±3) days prior to RT start and will continue until 14 days post RT end\n\nDermoRelizema cream: Fingertip units (FTU) depending from the extent of the affected skin to treat, two times per day for 7 (±3) days prior RT until about 14 (±3) days post RT end. The product can be used for further 2 weeks (from V3 to V4) in case of need, according to the investigator's judgment"}, {'id': 'OG001', 'title': 'Dexeryl', 'description': 'The treatment will be applied since 7 (±3) days prior to RT start and will continue until 14 days post RT end (98-112 applications in total).\n\nDexeryl: FTUs depending on the extent of the affected skin to treat, two times per day. The treatment will be applied since 7 (±3) days prior to RT start and will continue until 14 days post RT end (98-112 applications in total).'}], 'classes': [{'title': 'V1 skin healthy', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'V4 grade 0', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'all study visits, day 21-28, day 35-42 and at the study end (day 49-56)', 'description': 'Evaluation of the severity of radiation dermatitis by the investigator using the Radiation Dermatitis Severity (RDS) scoring scale. The severity of radiation dermatitis was measured using this scoring system, range 0.0 to 4.0 at increments of 0.5. The RDS score incorporates changes in redness, pigment, texture and integrity of the skin ( grade 0: best result, grade 4§: worst result)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluation of the severity of radiation dermatitis by the investigator'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Progression of Radio Therapy Induced Skin Reaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DermoRelizema Cream', 'description': "The treatment will be applied since about 7 (±3) days prior to RT start and will continue until 14 days post RT end\n\nDermoRelizema cream: Fingertip units (FTU) depending from the extent of the affected skin to treat, two times per day for 7 (±3) days prior RT until about 14 (±3) days post RT end. The product can be used for further 2 weeks (from V3 to V4) in case of need, according to the investigator's judgment"}, {'id': 'OG001', 'title': 'Dexeryl', 'description': 'The treatment will be applied since 7 (±3) days prior to RT start and will continue until 14 days post RT end (98-112 applications in total).\n\nDexeryl: FTUs depending on the extent of the affected skin to treat, two times per day. The treatment will be applied since 7 (±3) days prior to RT start and will continue until 14 days post RT end (98-112 applications in total).'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'all study visits, day 21-28, day 35-42 and at the study end (day 49-56)', 'description': 'Objective instrumental assessments of skin damage vascular parameters, tissue integrity and structural parameters,', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'instrumental assessments of skin damage vascular parameters, tissue integrity and structural parameters'}, {'type': 'SECONDARY', 'title': 'Patient Opinion on Cream With a Likert Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DermoRelizema Cream', 'description': "The treatment will be applied since about 7 (±3) days prior to RT start and will continue until 14 days post RT end\n\nDermoRelizema cream: Fingertip units (FTU) depending from the extent of the affected skin to treat, two times per day for 7 (±3) days prior RT until about 14 (±3) days post RT end. The product can be used for further 2 weeks (from V3 to V4) in case of need, according to the investigator's judgment"}, {'id': 'OG001', 'title': 'Dexeryl', 'description': 'The treatment will be applied since 7 (±3) days prior to RT start and will continue until 14 days post RT end (98-112 applications in total).\n\nDexeryl: FTUs depending on the extent of the affected skin to treat, two times per day. The treatment will be applied since 7 (±3) days prior to RT start and will continue until 14 days post RT end (98-112 applications in total).'}], 'classes': [{'title': 'smell pleasant/very pleasant', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'texture pleasant/very pleasant', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': 'spreadability pleasant/very pleasant', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'satisfaction pleasant/very pleasant', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 1 year', 'description': "Overall patient's opinion on the products' pleasantness", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "patient's opinion on the products' pleasantness"}, {'type': 'SECONDARY', 'title': 'Adherence to Treatment of Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DermoRelizema Cream', 'description': "The treatment will be applied since about 7 (±3) days prior to RT start and will continue until 14 days post RT end\n\nDermoRelizema cream: Fingertip units (FTU) depending from the extent of the affected skin to treat, two times per day for 7 (±3) days prior RT until about 14 (±3) days post RT end. The product can be used for further 2 weeks (from V3 to V4) in case of need, according to the investigator's judgment"}, {'id': 'OG001', 'title': 'Dexeryl', 'description': 'The treatment will be applied since 7 (±3) days prior to RT start and will continue until 14 days post RT end (98-112 applications in total).\n\nDexeryl: FTUs depending on the extent of the affected skin to treat, two times per day. The treatment will be applied since 7 (±3) days prior to RT start and will continue until 14 days post RT end (98-112 applications in total).'}], 'classes': [{'categories': [{'measurements': [{'value': '96.50', 'spread': '7.98', 'groupId': 'OG000'}, {'value': '97.50', 'spread': '8.82', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 1 year', 'description': "Patient's adherence to treatment on a diary's scale ( 10 points, in whitc: 1 is the best, 100 is the worst)", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Patient's adherence to treatment"}, {'type': 'SECONDARY', 'title': 'Occurrence of Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DermoRelizema Cream', 'description': "The treatment will be applied since about 7 (±3) days prior to RT start and will continue until 14 days post RT end\n\nDermoRelizema cream: Fingertip units (FTU) depending from the extent of the affected skin to treat, two times per day for 7 (±3) days prior RT until about 14 (±3) days post RT end. The product can be used for further 2 weeks (from V3 to V4) in case of need, according to the investigator's judgment"}, {'id': 'OG001', 'title': 'Dexeryl', 'description': 'The treatment will be applied since 7 (±3) days prior to RT start and will continue until 14 days post RT end (98-112 applications in total).\n\nDexeryl: FTUs depending on the extent of the affected skin to treat, two times per day. The treatment will be applied since 7 (±3) days prior to RT start and will continue until 14 days post RT end (98-112 applications in total).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 1 year', 'description': 'Occurrence of Adverse Events', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Adverse Events'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DermoRelizema Cream', 'description': "The treatment will be applied since about 7 (±3) days prior to RT start and will continue until 14 days post RT end\n\nDermoRelizema cream: Fingertip units (FTU) depending from the extent of the affected skin to treat, two times per day for 7 (±3) days prior RT until about 14 (±3) days post RT end. The product can be used for further 2 weeks (from V3 to V4) in case of need, according to the investigator's judgment"}, {'id': 'FG001', 'title': 'Dexeryl', 'description': 'The treatment will be applied since 7 (±3) days prior to RT start and will continue until 14 days post RT end (98-112 applications in total).\n\nDexeryl: FTUs depending on the extent of the affected skin to treat, two times per day. The treatment will be applied since 7 (±3) days prior to RT start and will continue until 14 days post RT end (98-112 applications in total).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'DermoRelizema Cream', 'description': "The treatment will be applied since about 7 (±3) days prior to RT start and will continue until 14 days post RT end\n\nDermoRelizema cream: Fingertip units (FTU) depending from the extent of the affected skin to treat, two times per day for 7 (±3) days prior RT until about 14 (±3) days post RT end. The product can be used for further 2 weeks (from V3 to V4) in case of need, according to the investigator's judgment"}, {'id': 'BG001', 'title': 'Dexeryl', 'description': 'The treatment will be applied since 7 (±3) days prior to RT start and will continue until 14 days post RT end (98-112 applications in total).\n\nDexeryl: FTUs depending on the extent of the affected skin to treat, two times per day. The treatment will be applied since 7 (±3) days prior to RT start and will continue until 14 days post RT end (98-112 applications in total).'}, {'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': '31', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.11', 'spread': '10.86', 'groupId': 'BG000'}, {'value': '59.56', 'spread': '9.43', 'groupId': 'BG001'}, {'value': '59.34', 'spread': '10.15', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '61', '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': '31', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '61', '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': 'Italy', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-06-30', 'size': 1160706, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-06-06T02:20', 'hasProtocol': True}, {'date': '2023-06-14', 'size': 1381771, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-06-06T02:22', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Assessments and evaluations will be performed by a physician in a blind fashion.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a post marketing, interventional, randomized, single-center, prospective, controlled study. Assessments and evaluations will be performed by a physician in a blind fashion.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2023-02-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-14', 'studyFirstSubmitDate': '2020-07-13', 'resultsFirstSubmitDate': '2024-06-27', 'studyFirstSubmitQcDate': '2020-07-20', 'lastUpdatePostDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-14', 'studyFirstPostDateStruct': {'date': '2020-07-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Progression of Radio Therapy Induced Skin Reaction', 'timeFrame': 'two weeks after the last RT sessiont,day 35-42', 'description': 'Evaluation of the effects of DermoRelizemaTM cream in the management of the progression of RT-induced skin reactions and toxicity'}], 'secondaryOutcomes': [{'measure': 'Progression of Radio Therapy-induced Skin Reactions Using the Grading System of the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/ EORTC)', 'timeFrame': 'at the conclusion of the radiotherapy treatment, day 21-28 and at the study end day 49-56, reported day 56', 'description': '1\\. Evaluation of the effects of DermoRelizemaTM cream, in the management of the progression of RT-induced skin reactions and toxicity, using the (RTOG/ EORTC) at the conclusion of the radiotherapy treatment (V2) and at study end (V4)'}, {'measure': 'Evaluation of the Radiation Symptoms (0 Best Result, 40 Worst Results)', 'timeFrame': 'up to 1 year', 'description': 'Evaluation of dermatitis symptoms management'}, {'measure': 'Severity of Radio Therapy-induced Skin Reactions Using the Grading System of the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/ EORTC)', 'timeFrame': 'all study visits, day 21-28, day 35-42 and at the study end (day 49-56)', 'description': 'Evaluation of the severity of radiation dermatitis by the investigator using the RTOG/ EORTC (system of the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer(grade 0-1: treatment is succesfull, grade 1 or magior: treatment insuccesful) ), at visits 2, 3 and 4'}, {'measure': 'Severity of Radiation Dermatitis With Radiation Dermatitis Severity (RDS) Scoring Scale', 'timeFrame': 'all study visits, day 21-28, day 35-42 and at the study end (day 49-56)', 'description': 'Evaluation of the severity of radiation dermatitis by the investigator using the Radiation Dermatitis Severity (RDS) scoring scale. The severity of radiation dermatitis was measured using this scoring system, range 0.0 to 4.0 at increments of 0.5. The RDS score incorporates changes in redness, pigment, texture and integrity of the skin ( grade 0: best result, grade 4§: worst result)'}, {'measure': 'Number of Participants With Progression of Radio Therapy Induced Skin Reaction', 'timeFrame': 'all study visits, day 21-28, day 35-42 and at the study end (day 49-56)', 'description': 'Objective instrumental assessments of skin damage vascular parameters, tissue integrity and structural parameters,'}, {'measure': 'Patient Opinion on Cream With a Likert Scale', 'timeFrame': 'up to 1 year', 'description': "Overall patient's opinion on the products' pleasantness"}, {'measure': 'Adherence to Treatment of Patients', 'timeFrame': 'up to 1 year', 'description': "Patient's adherence to treatment on a diary's scale ( 10 points, in whitc: 1 is the best, 100 is the worst)"}, {'measure': 'Occurrence of Adverse Events', 'timeFrame': 'up to 1 year', 'description': 'Occurrence of Adverse Events'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Radiodermatitis', 'DermoRelizema cream', 'DRESDA', 'Sodium Hyaluronate Butyrate Formiate', 'RELIFE'], 'conditions': ['Radiodermatitis', 'Dermatitis, Radiation-Induced']}, 'descriptionModule': {'briefSummary': 'This is a post marketing, interventional, randomized, single-center, prospective, controlled study, for the evaluation of the clinical performance and tolerability of a cream-based medical device (DermoRelizemaTM cream) in the management care of radiodermatitis in women with breast cancer. Assessments and evaluations will be performed by a physician in a blind fashion.\n\nThe primary objective is Evaluation of the effects of DermoRelizemaTM cream in the management of the progression of RT-induced skin reactions and toxicity, using the grading system of the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/ EORTC), at the conclusion of the treatment period', 'detailedDescription': 'This is a post marketing, interventional, randomized, single-center, prospective, controlled study, for the evaluation of the clinical performance and tolerability of a cream-based medical device (DermoRelizemaTM cream) in the management care of radiodermatitis in women with breast cancer. Assessments and evaluations will be performed by a physician in a blind fashion.\n\nThe aim of this clinical study is to collect controlled evidences of the effectiveness and tolerability of DermoRelizemaTM cream in the management of RISRs in patients with breast cancer who will start the treatment with the product about one week before the start of RT.\n\nThe primary objective is Evaluation of the effects of DermoRelizemaTM cream in the management of the progression of RT-induced skin reactions and toxicity, using the grading system of the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/ EORTC), at the conclusion of the treatment period'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'female patient with breast cancer', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Women who give their written consent for participation in the study and willing to comply with all its procedures.\n* Age ≥18 years.\n* Women with breast cancer at any stage who have undergone quadrantectomy, for whom hypofractionated adjuvant RT of the thoracic region is indicated.\n* RTOG/ EORTC radiodermatitis grade equal to 0 (zero) and good cutaneous trophism, in the region to be treated, according to investigator's judgement.\n* Patients who are supposed to be cooperative with regard to compliance with study-related constraints.\n\nExclusion Criteria:\n\n* Pregnant or lactating women (as not eligible to RT), and fertile women not following, at the investigators' judgement, an adequate contraceptive method.\n* Subjects incapable of giving consent.\n* Concomitant inflammatory skin diseases in acute phase such as: atopic dermatitis, contact dermatitis, psoriasis, lichen planus, pityriasis rosea.\n* Collagen vascular disease, vasculitis, scleroderma, dermatomyositis, or systemic lupus erythematosus.\n* Unhealed surgical sites, breast infections.\n* Bilateral breast cancer or multiple neoplasia needing other independent RT treatments.\n* Prior breast reconstructions, implants, and/or expanders.\n* Known radio-sensitivity syndromes (e.g. ataxia-telangiectasia).\n* Known history of intolerance or hypersensitivity to any ingredient of the study products.\n* Previous RT in the same or different location.\n* Topical pharmacological and medical device treatments on the skin region affected by the RT, in the last 2 weeks.\n* Systemic or topical (including inhaled or intranasal) treatments containing corticosteroids of any class in the 2 days preceding the enrolment.\n* Photo-therapy (PUVA, UVB) in the 2 weeks preceding the enrolment and/or planned to be administered during the course of the study.\n* Participation in another clinical trial at the time of the randomization or within 28 days before randomization.\n* Patient's difficulties or problems, in the judgment of the investigator, in being compliant with study procedures and requirements, including social or mental constrains."}, 'identificationModule': {'nctId': 'NCT04483856', 'acronym': 'DRESDA', 'briefTitle': 'Efficacy and Tolerability Evaluation of a Topical MD Based on SHBF in Management of Radiodermatitis.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Relife Italia S.r.l.'}, 'officialTitle': 'Efficacy and Tolerability Evaluation of a Topical Medical Device Based on SHBF in Management of Radiodermatitis. An Observer-masked, Controlled Study.', 'orgStudyIdInfo': {'id': 'RELI/19/Der-Rdt/001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DermoRelizema cream', 'description': 'The treatment will be applied since about 7 (±3) days prior to RT start and will continue until 14 days post RT end', 'interventionNames': ['Device: DermoRelizema cream']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dexeryl', 'description': 'The treatment will be applied since 7 (±3) days prior to RT start and will continue until 14 days post RT end (98-112 applications in total).', 'interventionNames': ['Device: Dexeryl']}], 'interventions': [{'name': 'DermoRelizema cream', 'type': 'DEVICE', 'description': "Fingertip units (FTU) depending from the extent of the affected skin to treat, two times per day for 7 (±3) days prior RT until about 14 (±3) days post RT end. The product can be used for further 2 weeks (from V3 to V4) in case of need, according to the investigator's judgment", 'armGroupLabels': ['DermoRelizema cream']}, {'name': 'Dexeryl', 'type': 'DEVICE', 'description': 'FTUs depending on the extent of the affected skin to treat, two times per day. The treatment will be applied since 7 (±3) days prior to RT start and will continue until 14 days post RT end (98-112 applications in total).', 'armGroupLabels': ['Dexeryl']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41134', 'city': 'Modena', 'country': 'Italy', 'facility': 'Modena University Hospital', 'geoPoint': {'lat': 44.64783, 'lon': 10.92539}}], 'overallOfficials': [{'name': 'Mariangela Francomano', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Modena and Reggio Emilia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'confidential information as per internal procedure of the Sponsor'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Relife Italia S.r.l.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}