Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2025-12-25 @ 5:22 PM
Study NCT ID:
NCT03546803
Status:
COMPLETED
Last Update Posted:
2019-08-14
First Post:
2018-05-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
3M Cavilon Advanced Skin Protectant for the Prophylaxis 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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-08-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-12', 'studyFirstSubmitDate': '2018-05-23', 'studyFirstSubmitQcDate': '2018-05-23', 'lastUpdatePostDateStruct': {'date': '2019-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'compare radiation dermatitis severity', 'timeFrame': '3 months (+/- 1 month) following the completion of radiation therapy', 'description': 'To compare radiation dermatitis severity in irradiated skin protected by a liquid skin protectant (3M™ Cavilon™ Advanced Skin Protectant) that rapidly dries versus uncovered skin (internal control) as determined by a panel.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Radiation Dermatitis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'This study observes a liquid skin protectant that is a polymeric-cyanoacrylate solution designed to protect intact or damaged skin due to radiation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Radiation therapy patients', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18years.\n* Patient has initial or recurrent disease\n* Undergoing external beam radiotherapy at the Mayo Clinic Rochester campus Note: Patients who are undergoing concurrent chemotherapy are eligible\n* Ability to complete questionnaire(s) by themselves or with assistance\n* Provide informed written consent\n* Willing to consent for photography of radiation field\n* Available to return to Mayo Clinic in within 1 week post treatment for assessment (+/- 7 days).\n* At risk for developing ≥ grade 2 dermatitis radiation as determined by treating Radiation Oncology clinician\n* Biologic effective dose of \\>42 Gy10 as calculated using the web site EQD2.com.\n\nExclusion Criteria:\n\n* Unable to provide informed consent\n* Patients with active rash, pre-existing dermatitis, lupus or scleroderma within the treatment area that may make skin assessment for the study difficult\n* Known history of developing an allergic reaction after using a product containing cyanoacrylate or acrylates\n* Subject has a medical condition that in the opinion of the investigator should exclude him/her from participating in the study\n* Subject has been enrolled in an investigational study where product was applied to the proposed study site within 30 days of the screening visit\n* The skin area affected by radiation requires treatment with a concomitant medication or product (if applicable)'}, 'identificationModule': {'nctId': 'NCT03546803', 'briefTitle': '3M Cavilon Advanced Skin Protectant for the Prophylaxis of Radiation Dermatitis', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Assessment of 3M Cavilon Advanced Skin Protectant for the Prophylaxis of Radiation Dermatitis in Cancer Patients', 'orgStudyIdInfo': {'id': '17-006813'}, 'secondaryIdInfos': [{'id': 'ROR1603', 'type': 'OTHER', 'domain': 'Mayo Clinic'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort A', 'description': 'Head and Neck Patients; Photon or Proton Treatment with product', 'interventionNames': ['Other: 3M™ Cavilon™ Advanced Skin Protectant']}, {'label': 'Cohort B', 'description': 'Hair/skin fold areas (Axilla, Groin, Perineum); Photon or Proton Treatment with product', 'interventionNames': ['Other: 3M™ Cavilon™ Advanced Skin Protectant']}, {'label': 'Cohort C', 'description': 'Misc. (per Rad Onc Physician); Photon or Proton Therapy with routine skin care', 'interventionNames': ['Other: 3M™ Cavilon™ Advanced Skin Protectant']}], 'interventions': [{'name': '3M™ Cavilon™ Advanced Skin Protectant', 'type': 'OTHER', 'description': 'liquid skin protectant on skin to protect from radiation dermatitis', 'armGroupLabels': ['Cohort A', 'Cohort B', 'Cohort C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Radiation Oncology Consultant', 'investigatorFullName': 'Ivy A. Petersen, M.D.', 'investigatorAffiliation': 'Mayo Clinic'}}}}