Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2026-01-01 @ 1:02 AM
Study NCT ID:
NCT00360932
Status:
COMPLETED
Last Update Posted:
2019-09-18
First Post:
2006-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Facial Lipoatrophy Correction Experience With SCULPTRA ("FACES" Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 290}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-14', 'studyFirstSubmitDate': '2006-08-03', 'studyFirstSubmitQcDate': '2006-08-04', 'lastUpdatePostDateStruct': {'date': '2019-09-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-08-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate, by Fitzpatrick skin type and by gender, long-term safety of Poly-L-Lactic acid injection(s) in human immunodeficiency virus subjects with facial lipoatrophy.', 'timeFrame': '5 years'}], 'secondaryOutcomes': [{'measure': 'Evaluate the incidence of hypertrophic scars or keloids in subjects by Fitzpatrick skin types IV-VI, assessed approximately 6 months after completion of treatment;', 'timeFrame': '5 years'}, {'measure': 'Evaluate the severity, relationship, time to onset, duration, and resolution of adverse events (AEs) by Fitzpatrick skin type and gender; and', 'timeFrame': '5 years'}, {'measure': 'Evaluate the Quality of Life (QOL) and body image benefit associated with the treatment of facial lipoatrophy.', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['facial lipoatrophy', 'HIV/AIDs'], 'conditions': ['Facial Lipoatrophy']}, 'descriptionModule': {'briefSummary': '5 year, open-label study to evaluate safety of SCULPTRA on the signs of lipoatrophy of the face in at least 100 evaluable subjects with human immunodeficiency virus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Subjects seropositive for human immunodeficiency virus who in the investigator's judgment, have a high probability of 5 year survival and compliance with the study visit schedule, and are initiating SCULPTRA treatments.", 'healthyVolunteers': False, 'eligibilityCriteria': "INCLUSION CRITERIA:\n\n* Subjects seropositive for human immunodeficiency virus;\n* In the investigator's judgment, a high probability of 5 year survival and compliance with the study visit schedule;\n* Initiating SCULPTRA treatments;\n* Ability to comprehend and sign an informed consent document prior to study enrollment.\n* No waiver, prospective or retrospective, to deviate in any way from the inclusion/exclusion criteria for clinical study subjects, defined in the study protocol, can be granted to clinical investigators.\n\nEXCLUSION CRITERIA\n\n* Any active skin inflammation or infection in or near the treatment area;\n* Any hypersensitivity to the components of SCULPTRA\n* Previous treatment with SCULPTRA or any other product for facial lipoatrophy;\n* Pregnancy or breastfeeding or anticipating becoming pregnant during the study period; and\n* Any other excluding factors that, according to the investigator's judgment, would preclude enrollment in the study.\n* No waiver, prospective or retrospective, to deviate in any way from the inclusion/exclusion criteria for clinical study subjects, defined in the study protocol, can be granted to clinical investigators."}, 'identificationModule': {'nctId': 'NCT00360932', 'acronym': 'FACES', 'briefTitle': 'Facial Lipoatrophy Correction Experience With SCULPTRA ("FACES" Study)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bausch Health Americas, Inc.'}, 'officialTitle': 'An Open-Label Registry Study of the Facial Lipoatrophy Correction Experience With SCULPTRA® in Subjects With Human Immunodeficiency Virus (FACES Study)', 'orgStudyIdInfo': {'id': 'DL6049-0417'}}, 'armsInterventionsModule': {'interventions': [{'name': 'SCULPTRA (poly-L-lactic acid injection)', 'type': 'DEVICE', 'description': "Subjects will be treated with SCULPTRA® according to the investigator's judgment, and in accordance with the SCULPTRA® package insert. Details of the exact amount and the time of administration of SCULPTRA® (date, amount, location) will be documented in the CRF at each protocol and non-protocol visit."}]}, 'contactsLocationsModule': {'locations': [{'zip': '08807', 'city': 'Bridgewater', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 40.60079, 'lon': -74.64815}}], 'overallOfficials': [{'name': 'Tara Semanchek, MBA', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bausch Health Americas, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}