Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT07094620
Status:
COMPLETED
Last Update Posted:
2025-07-30
First Post:
2025-07-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Non-surgical Rhinoplasty After Nasal Skin Cancer Reconstruction: Enhancing Aesthetic Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-05-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-23', 'studyFirstSubmitDate': '2025-07-23', 'studyFirstSubmitQcDate': '2025-07-23', 'lastUpdatePostDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of FACE-Q questionnaire score', 'timeFrame': 'Baseline, One month and at Two months', 'description': 'Face-Q is a validated questionnaire evaluating patients PROMs in aesthetic procedures.'}], 'secondaryOutcomes': [{'measure': 'Standardized and 3-Dimensions photographs', 'timeFrame': 'Baseline, One month and at Two months', 'description': 'Standardized photographs taken with a camera'}, {'measure': '3-Dimensions photographs', 'timeFrame': 'Baseline, One month and at Two months', 'description': '3-Dimensions photographs acquired by using the Vectra System with evaluation of volumetric changes'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Plastic Surgery Procedures']}, 'descriptionModule': {'briefSummary': 'Reconstruction of the nasal pyramid after skin cancer is a complex surgery, often involving multiple stages. For some patients, the final result may be considered insufficient, affecting their quality of life and leading to social isolation, in addition to requiring numerous surgeries. In this context, and with the expertise of our department in this field, patients may benefit from touch-ups using hyaluronic acid, which can improve the outcome without the need for major and costly surgery. This product has the advantages of being accessible, easy to use, and has demonstrated long-term safety in the literature.The aim of the study is to evaluate, in this context, the benefit of medical rhinoplasty as perceived by the patients, as well as to measure the objective volumetric gain using 3-D photography. It also seeks to encourage professionals in this type of surgery to assess the results and motivate them to train in these techniques.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who had undergone non-surgical rhinoplasty with hyaluronic acid injections following surgery to remove nasal skin cancer and who reported dissatisfaction with aesthetic outcomes', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A history of nasal skin carcinoma treated surgically with reconstruction, a minimum of one year since the last oncologic surgery, a patient-expressed desire for aesthetic improvement, and either refusal of further surgery or a context in which surgical revision was uncertain or not recommended\n\nExclusion Criteria:\n\n* Any standard contraindications to hyaluronic acid injections, oncologic surgery performed less than one year prior or with uncertain resection margins, metastatic evolution and cases where surgical correction remained more appropriate and accessible than injection-based management'}, 'identificationModule': {'nctId': 'NCT07094620', 'briefTitle': 'Non-surgical Rhinoplasty After Nasal Skin Cancer Reconstruction: Enhancing Aesthetic Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'officialTitle': 'Non-surgical Rhinoplasty After Nasal Skin Cancer Reconstruction: Enhancing Aesthetic Outcomes', 'orgStudyIdInfo': {'id': '25Rhino01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Non-surgical rhinoplasty', 'type': 'RADIATION', 'description': 'Non-surgical rhinoplasty using hyaluronic acid at baseline consultation.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '0600', 'city': 'Nice', 'state': 'Alpes Maritimes', 'country': 'France', 'facility': 'CHU NICE', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}