Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2025-12-25 @ 7:08 PM
Study NCT ID:
NCT07261904
Status:
RECRUITING
Last Update Posted:
2025-12-03
First Post:
2025-11-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
BIOCHROMADERM® PMCF STUDY
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 115}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-06-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-29', 'studyFirstSubmitDate': '2025-11-20', 'studyFirstSubmitQcDate': '2025-11-29', 'lastUpdatePostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-10-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To confirm the continued performance of BIOCHROMADERM® in restoring a near-normal pigmentary appearance of the nipple-areola complex at 3 months post-pigmentation', 'timeFrame': '3 months post-pigmentation'}], 'secondaryOutcomes': [{'measure': 'To confirm the continued safety of BIOCHROMADERM®', 'timeFrame': '12 months'}, {'measure': 'To confirm adequate usability and describe the optimal process for BIOCHROMADERM® implantation', 'timeFrame': '12 months'}, {'measure': 'To assess the long-term performance of BIOCHROMADERM® in restoring a near-normal pigmentary appearance of the nipple-areola complex at 12 months post-pigmentation (Likert scale)', 'timeFrame': '12 months'}, {'measure': 'To assess the evolution of performance (Likert scale) between baseline, 3 months and 12 months post-pigmentation', 'timeFrame': '12 months'}, {'measure': 'To assess fading (pigment retention potential) over 12 months', 'timeFrame': '12 months'}, {'measure': 'To assess the number of pigmentation adjustments needed per patient throughout the study duration', 'timeFrame': '12 months'}, {'measure': "To assess patient's satisfaction/self-confidence evolution post-treatment, both in terms of general breast appearance and as to the specific dermo-pigmentation stage", 'timeFrame': '12 months'}, {'measure': 'To assess the correlation of the esthetic satisfaction/self-confidence questionnaire outcomes with those of the Likert Scale and patient satisfaction VAS at 3 months and 12 months post-pigmentation', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Reconstruction of the Nipple-areola Complex in Patients Undergoing Breast Reconstructive Surgery Following Mastectomy']}, 'descriptionModule': {'briefSummary': "The goal of this observational study is to:\n\n* To confirm the continued performance of BIOCHROMADERM® in restoring a near-normal pigmentary appearance of the nipple-areola complex at 3 months post-pigmentation;\n* To confirm the continued safety of BIOCHROMADERM®,\n* To confirm adequate usability and describe the optimal process for BIOCHROMADERM® implantation\n* To assess the long-term performance of BIOCHROMADERM® in restoring a near-normal pigmentary appearance of the nipple-areola complex at 12 months post-pigmentation (Likert scale)\n* To assess the evolution of performance (Likert scale) between baseline, 3 months and 12 months post-pigmentation\n* To assess fading (pigment retention potential) over 12 months\n* To assess the number of pigmentation adjustments needed per patient throughout the study duration\n* To assess patient's satisfaction/self-confidence evolution post-treatment, both in terms of general breast appearance and as to the specific dermo-pigmentation stage\n* To assess the correlation of the esthetic satisfaction/self-confidence questionnaire outcomes with those of the Likert Scale and patient satisfaction VAS at 3 months and 12 months post-pigmentation"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients requiring the correction of skin pigmentation in the NAC area as a result of breast reconstructive surgery following mastectomy.\n\nUp to 115 patients will be included into the study by 3 clinical sites, in order to obtain 103 treated patients followed up over 12 months post-procedure per protocol', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female or male ≥18 years old,\n* Requiring the reconstruction of the nipple-areola complex following mastectomy,\n* Affiliated or beneficiary of a social security scheme,\n* Able and willing to provide written informed consent to study participation.\n\nExclusion Criteria:\n\n* Known allergy to pigment ingredients\n* Active, recent or prior history of skin disease, chronic skin disease, history of hypertrophic scars, skin infection or skin inflammatory disease,\n* Patients carrying a prosthesis (especially cardiac),\n* Patients presenting with a coagulation disorder,\n* Patients scheduled for an MRI within 6 months following pigmentation,\n* Patients scheduled for a skin esthetic treatment close to the pigmentation zone (laser, peeling, abrasion, ...) shortly after pigmentation,\n* Existing medical condition or organ pathology close to the skin that the Investigator considers may put the patient at risk or compromise their participation in the study,\n* Pregnant or breastfeeding female,\n* Currently participating to another clinical trial or having participated to a prior clinical trial within 1 month prior to inclusion into the present one,\n* Personal strong objection to medical tattooing,\n* Psychiatric illness/social situations that would limit ability to consent and/or to compliance with study requirements,\n* Under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision.\n\nNote: The recent use of permanent wrinkle or lip filling products close to the scheduled pigmentation zone (silicon, PTFE, ...) is a contraindication in the approved product IFU but is not relevant to the breast reconstruction indication.'}, 'identificationModule': {'nctId': 'NCT07261904', 'briefTitle': 'BIOCHROMADERM® PMCF STUDY', 'organization': {'class': 'INDUSTRY', 'fullName': 'Laboratoires BIOTIC Phocea'}, 'officialTitle': 'Prospective, Observational, Multicentre, Single Group, Open-label Study to Confirm the Safety and Effectiveness of BIOCHROMADERM® Ink for the Reconstruction of the Nipple-areola Complex in Patients Undergoing Breast Reconstructive Surgery Following Mastectomy', 'orgStudyIdInfo': {'id': 'ID-RCB 2024-A01845-42'}}, 'contactsLocationsModule': {'locations': [{'city': 'Lille', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Claudia Regis, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Oscar Lambret', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Marseille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Dominique Casanova, Professor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital de La Conception', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Vandœuvre-lès-Nancy', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Laetitia Goffinet, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institut de Cancérologie de Lorraine', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}], 'centralContacts': [{'name': 'Marie-Hélène BACHELEY', 'role': 'CONTACT', 'email': 'regulatory@biotic.fr', 'phone': '+33785453676'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laboratoires BIOTIC Phocea', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Clinical Research Consultants, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}