Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2026-01-17 @ 5:27 AM
Study NCT ID:
NCT07010692
Status:
RECRUITING
Last Update Posted:
2025-09-17
First Post:
2025-05-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treating Basal and Squamous Cell Carcinomas With Fractional Laser and Tirbanibulin Ointment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002280', 'term': 'Carcinoma, Basal Cell'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018295', 'term': 'Neoplasms, Basal Cell'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-05-16', 'size': 204182, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-05-27T16:15', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2030-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-15', 'studyFirstSubmitDate': '2025-05-30', 'studyFirstSubmitQcDate': '2025-05-30', 'lastUpdatePostDateStruct': {'date': '2025-09-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clearance of skin cancer by evidence of no clinical and/or histological recurrence after 5 years.', 'timeFrame': 'From enrollment to the end of follow-up monitoring at 5 years.', 'description': 'Participants will be monitored at 1 month post-procedure then biannually thereafter for 5 years. Site with be observed for clinical recurrence. Optional biopsy at each visit.'}], 'secondaryOutcomes': [{'measure': 'Recurrence rate/Appearance/Patient Satisfaction as compared to accepted alternatives (Surgical excision, Mohs, Electrodesiccation and curettage)', 'timeFrame': 'Ongoing review from enrollment to the end of 5 year follow-up period & also a final review at the end of 5 years for all participants.', 'description': 'Review the overall success of the treatment (recurrence and failure rates, appearance, patient satisfaction) compared to traditionally accepted alternative treatments including surgical excision, Mohs surgery, and Electrodesiccation and curettage'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Basal Cell Carcinoma', 'Squamous Cell Carcinoma', 'BCC', 'SCC', 'keratinocyte carcinoma', 'skin cancer', 'laser treatment'], 'conditions': ['Keratinocyte Carcinoma', 'Basal Cell Carcinomas', 'Squamous Cell Carcinoma', 'Skin Cancer']}, 'referencesModule': {'references': [{'pmid': '39400600', 'type': 'RESULT', 'citation': 'Robinson BP, Nanni GM. Utilizing fractional lasers and tirbanibulin ointment to treat squamous and basal cell carcinomas. Arch Dermatol Res. 2024 Oct 14;316(10):683. doi: 10.1007/s00403-024-03423-0.'}], 'seeAlsoLinks': [{'url': 'https://www.brucerobinsonmd.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The investigators seek to evaluate the effectiveness of fractional laser therapy and tirbanibulin ointment to treat squamous and basal cell carcinomas. This will be executed by using both thulium and erbium lasers on previously biopsy-confirmed SCCs and BCCs and applying bulk heating methods. Then, depending on the level of invasiveness, subjects may be instructed to apply the ointment over the course of five nights immediately following the treatment. The intention of this study is to minimize the need for invasive surgical procedures so as to optimize the cosmetic appearance, and provide a treatment option that is beneficial for a wide range of individuals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: biopsy confirmed squamous and/or basal cell carcinoma not previously treated by another method.\n\nExclusion Criteria:\n\n* Cannot be pregnant at the time of treatment'}, 'identificationModule': {'nctId': 'NCT07010692', 'briefTitle': 'Treating Basal and Squamous Cell Carcinomas With Fractional Laser and Tirbanibulin Ointment', 'organization': {'class': 'OTHER', 'fullName': 'Bruce Robinson, MD'}, 'officialTitle': 'Using Fractional Lasers and Tirbanibulin Ointment to Treat Keratinocyte Carcinomas', 'orgStudyIdInfo': {'id': '25-06-003-2015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Fractional Laser Only', 'description': 'Treatment of superficial or in situ carcinomas will be with fractional laser only.', 'interventionNames': ['Device: non-ablative fractional laser']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fractional Laser and Tirbanibulin Ointment', 'description': 'Treatment of nodular or invasive carcinomas will be with fractional laser followed by a course of Klisyri ointment.', 'interventionNames': ['Drug: Tirbanibulin ointment 1%', 'Device: non-ablative fractional laser']}], 'interventions': [{'name': 'Tirbanibulin ointment 1%', 'type': 'DRUG', 'description': 'Tirbanibulin ointment is applied for 5 nights following the in-office fractional laser procedure for patients with more advanced carcinomas.', 'armGroupLabels': ['Fractional Laser and Tirbanibulin Ointment']}, {'name': 'non-ablative fractional laser', 'type': 'DEVICE', 'description': 'Every skin cancer will be treated with two wavelengths (1550nm and 1927nm) of a non-ablative fractional laser.', 'armGroupLabels': ['Fractional Laser Only', 'Fractional Laser and Tirbanibulin Ointment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10022', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Gillian Nanni, Research Coordinator', 'role': 'CONTACT', 'email': 'info@brucerobinsonmd.com', 'phone': '212-750-7121'}, {'name': 'Lexi Research Assistant', 'role': 'CONTACT', 'email': 'info@brucerobinsonmd.com', 'phone': '212-750-7121'}, {'name': 'Bruce Robinson, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Bruce Robinson, MD', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'Gillian Nanni, Research Coordinator, BS', 'role': 'CONTACT', 'email': 'info@brucerobinsonmd.com', 'phone': '212-750-7121'}], 'overallOfficials': [{'name': 'Bruce Robinson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bruce Robinson, MD'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bruce Robinson, MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}