Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 11:54 PM
Study NCT ID:
NCT05810194
Status:
COMPLETED
Last Update Posted:
2024-02-01
First Post:
2023-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retrospective Cohort Study Comparing a Novel Gel Dressing vs SoC in the Treatment of Radiation Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010577', 'term': 'Petrolatum'}], 'ancestors': [{'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 344}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-31', 'studyFirstSubmitDate': '2023-03-30', 'studyFirstSubmitQcDate': '2023-03-30', 'lastUpdatePostDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CTCAE for Radiation Dermatitis', 'timeFrame': '5 weeks', 'description': 'Acute radiation dermatitis measured weekly during radiotherapy treatment, using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 score (grade 0 - 5). A higher grade is considered a worse outcome.'}], 'secondaryOutcomes': [{'measure': 'CTCAE for Hyperpigmentation', 'timeFrame': '5 weeks', 'description': 'Acute hyperpigmentation measured weekly during radiotherapy treatment, using the Common Terminology Criteria for Adverse Events (CTCAE) score (grade 0 - 2). A higher grade is considered a worse outcome.'}, {'measure': 'Number of patients requiring burn cream application', 'timeFrame': '5 weeks', 'description': 'Total number of patients that required burn cream application during radiotherapy'}, {'measure': 'Interval between radiotherapy start and burn cream application', 'timeFrame': '5 weeks', 'description': 'Number of days between initiation of radiation therapy and first application of burn cream during radiotherapy'}, {'measure': 'Number of patients requiring Mepilex application', 'timeFrame': '5 weeks', 'description': 'Total number of patients that required Mepilex application during radiotherapy'}, {'measure': 'Interval between radiotherapy start and Mepilex application', 'timeFrame': '5 weeks', 'description': 'Number of days between initiation of radiation therapy and first application of Mepilex during radiotherapy'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Radiation Dermatitis']}, 'descriptionModule': {'briefSummary': 'Routinely collected data on radiation-induced skin toxicity from 2010 to 2022 will be retrospectively analyzed. Data will be split into two cohorts: patients that received 1) StrataXRT and 2) standard of care. The incidence of grade ≥ 2 radiation dermatitis, the time to onset of grade ≥ 2 radiation dermatitis, the radiation dose at onset of grade ≥ 2 radiation dermatitis, the incidence of moist desquamation and the number of treatment interruptions will be compared between the cohorts.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Head and neck cancer patients treated with radiation therapy at UCLA from 2010 to 2022', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with Head and Neck cancer treated with radiation therapy with or without chemotherapy\n* Fractionated courses including at least 30 fractions (treatments)\n* Minimum of 18 completed radiation treatments\n* Radiation dose: \\> 50 Gy\n* Radiation technique: IMRT\n* Radiation equipment: TrueBeam or Tomotherapy\n\nExclusion Criteria:\n\n* Prior radiation to the treatment area\n* Patients with any medical condition such as active connective tissue disorder that predisposes them to an increased risk of potentially severe radiation dermatitis.\n* Patients undergoing SBRT\n* Patients with existing rashes or wounds in the target region or radiation therapy at RT start\n* Patients receiving hypofractionation\n* Patient receiving bolus'}, 'identificationModule': {'nctId': 'NCT05810194', 'briefTitle': 'Retrospective Cohort Study Comparing a Novel Gel Dressing vs SoC in the Treatment of Radiation Dermatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Stratpharma AG'}, 'officialTitle': 'Retrospective Cohort Study Comparing a Novel Silicone Gel Wound Dressing vs Standard of Care in the Treatment of Radiation Dermatitis', 'orgStudyIdInfo': {'id': 'SPASX020'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'StrataXRT', 'interventionNames': ['Device: StrataXRT']}, {'label': 'Standard of care', 'interventionNames': ['Drug: Calendula', 'Drug: Aquaphor']}], 'interventions': [{'name': 'StrataXRT', 'type': 'DEVICE', 'description': 'StrataXRT® is a TGA-approved silicone-based topical preparation. StrataXRT is a self-drying, non-sticky, transparent, silicone gel formulation and when used as directed, dries to form an inert, thin, flexible wound dressing with a protective layer that is gas permeable and waterproof. It is the only self-drying topical silicone gel indicated for the use on radiation dermatitis, which hydrates and protects compromised skin areas and open wounds from chemical and microbial invasion. StrataXRT helps create an optimal wound healing environment which leads to faster re-epithelialization and a reduced inflammatory response. The product can be applied to fresh incisions and excisions, open wounds and compromised skin surfaces.', 'armGroupLabels': ['StrataXRT']}, {'name': 'Calendula', 'type': 'DRUG', 'description': 'Calendula creams are over-the-counter (OTC) skin care ointments that are non-greasy, non-sticky, and quickly absorbed by the skin. Calendula is a topical agent derived from a plant of the marigold family Calendula Officinalis and is used in cuts, scrapes, chafing and minor burns. Containing numerous polyphenolic antioxidants, calendula has been studied in both the laboratory and clinical setting for the use in treating and preventing radiation induced skin toxicity.', 'armGroupLabels': ['Standard of care']}, {'name': 'Aquaphor', 'type': 'DRUG', 'description': 'Aquaphor, containing 41 percent petrolatum (or petroleum jelly), temporarily protects minor cuts, scrapes, and burns; Aquaphor protects and helps relieve chapped or cracked skin and lips, as well as helps protecting from the drying effects of wind and cold weather.', 'armGroupLabels': ['Standard of care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stratpharma AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}