Ignite Creation Date:
2025-12-24 @ 1:06 PM
Ignite Modification Date:
2026-02-23 @ 6:25 AM
Study NCT ID:
NCT06016361
Status:
UNKNOWN
Last Update Posted:
2023-08-29
First Post:
2023-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of a Novel Amino Acid Based Moisturizing Cream as Part of the Daily Standard Skincare Regimen Recommended During Radiation Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004890', 'term': 'Erythema'}], 'ancestors': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-09-18', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2024-03-18', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-23', 'studyFirstSubmitDate': '2023-08-09', 'studyFirstSubmitQcDate': '2023-08-23', 'lastUpdatePostDateStruct': {'date': '2023-08-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in Erythema', 'timeFrame': 'Up to 12 weeks', 'description': 'Evaluation of skin redness (both severity and size) with ScarletRed technology'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Erythema', 'Radiation Therapy, Secondary Skin Reactions']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical study is to evaluate a novel amino acid based moisturizing cream as part of the daily standard skincare regimen recommended during radiation therapy. The main aim of this study is to assess if the investigational product can improve skin redness associated with radiation therapy. Participants will apply a moisturizer daily during the course of their prescribed radiation therapy for breast cancer. Researchers will compare against the standard of care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provision of signed and dated informed consent form.\n* Aged over 18 years old.\n* Has been diagnosed with breast cancer and prescribed radiotherapy as a part of their cancer treatment.\n* Planned radiotherapy, as prescribed by the oncologist, is expected to provide a total radiation dose of up to 60 gray within the first 4 weeks of treatment.\n* Be able to adhere to proposed daily wound/site care as proposed by the protocol in line with the AADs recommendations.\n\nExclusion Criteria:\n\n* Pre-existing skin conditions which in the opinion of the investigator could impact on the integrity of the study or compromise the safety of the patient (i.e., active eczema, psoriasis, or an open wound over the planned site of radiation).\n* Have a concurrent medical condition or poor functional baseline which in the opinion of the investigator would make them unsuitable or able to fully comply with the study protocol.\n* Are pregnant or actively breast feeding.\n* Known allergic reactions to ingredients of the Investigational Product or the Standard of Care.'}, 'identificationModule': {'nctId': 'NCT06016361', 'briefTitle': 'Evaluation of a Novel Amino Acid Based Moisturizing Cream as Part of the Daily Standard Skincare Regimen Recommended During Radiation Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Entrinsic Bioscience Inc.'}, 'officialTitle': 'Evaluation of a Novel Amino Acid Based Moisturizing Cream as Part of the Daily Standard Skincare Regimen Recommended During Radiation Therapy', 'orgStudyIdInfo': {'id': 'PR-23809'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Standard of Care', 'description': 'Standard of Care', 'interventionNames': ['Other: Standard of care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Investigational Product', 'description': 'Investigational product', 'interventionNames': ['Other: VS-200Cr']}], 'interventions': [{'name': 'VS-200Cr', 'type': 'OTHER', 'description': 'Topical cream with moisturizing factors.', 'armGroupLabels': ['Investigational Product']}, {'name': 'Standard of care', 'type': 'OTHER', 'description': 'AAD recommended course of care.', 'armGroupLabels': ['Standard of Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33908', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'contacts': [{'name': 'Samantha Niles, MS', 'role': 'CONTACT', 'email': 'sniles@entrinsic.com', 'phone': '781-881-5165'}, {'name': 'Todd Pezzi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Advocate Radiation Oncology', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}], 'centralContacts': [{'name': 'Samantha Niles, MS', 'role': 'CONTACT', 'email': 'sniles@entrinsic.com', 'phone': '7818815165'}, {'name': 'Robert Kenefick, PhD', 'role': 'CONTACT', 'email': 'rkenefick@entrinsic.com', 'phone': '7818815165'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Entrinsic Bioscience Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}