Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-03-03 @ 4:14 AM
Study NCT ID:
NCT06703294
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-11-25
First Post:
2024-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective, Multicenter, Blind, Randomized Controlled, Optimal Clinical Trial to Evaluate the Safety and Efficacy of Medical Collagen Fillers for Facial Dermal Tissue Filling to Correct Frontal Wrinkles (crow's Feet)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 260}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-21', 'studyFirstSubmitDate': '2024-11-21', 'studyFirstSubmitQcDate': '2024-11-21', 'lastUpdatePostDateStruct': {'date': '2024-11-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blind investigators graded the severity of wrinkles at 1 month, 6 months, and 12 months after the last treatment Table (WSRS) score', 'timeFrame': 'Blind investigators graded the severity of wrinkles at 1 month, 6 months, and 12 months after the last treatment Table (WSRS) score'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intentional Correction of Forehead Wrinkles (crow's Feet)']}, 'descriptionModule': {'briefSummary': "With the development of medical technology and the improvement of life treatment, people's concept of aging is also changing, people of all ages are constantly pursuing a young and healthy life, the use of lasers and fillers to correct facial wrinkles has become more and more common. For the use of fillers to correct facial wrinkles, the efficacy and safety have been fully established, to the extent that it is a minimally invasive treatment, due to its short operation time and rapid recovery, it is considered a very effective treatment for facial wrinkles.\n\nCollagen is a kind of natural protein. As the main component of skin tissue, it has the advantages of good biocompatibility, degradability and low immunogenicity, and is an ideal material for correcting facial soft tissue defects. Collagen is implanted under the skin in a non-surgical way to increase the capacity of the dermis tissue, thus achieving the purpose of smoothing wrinkles, improving facial defects, and sculpting perfect skin. The medical collagen filling agent of Filaman (Changchun) Pharmaceutical Biotechnology Co., Ltd. consists of 3.5% bovine collagen It is composed of 0.3% lidocaine hydrochloride saline suspension, and is filled by injection to repair the shape and correct the contour to achieve satisfactory results. The product is eventually completely degraded in the human body, and the expected absorption time is 6-12 months.\n\nIn accordance with the requirements of the Medical Device Registration and Filing Management Measures, the Medical Device Clinical Trial Quality Management Standards, the Clinical Trial Registration Review Guidelines for Facial Injection Fillers (Draft for Comment), the Clinical Trial Design Guidelines for Medical devices, and the ethical principles of the Declaration of Helsinki of the World Medical Congress, To maximize the benefit of the subject and avoid as much harm as possible."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 18-65 years old (including 18 and 65 years old), regardless of gender; Intentional correction of forehead wrinkles (crow's feet);\n\nExclusion Criteria:\n\n* Received bovine collagen fillers or hyaluronic acid within 12 months prior to enrollment\n\nFacial area of calcium hydroxyapatite (CaHA), poly-L-lactic acid (PLLA) or plastic therapy\n\nDomain therapy, or subjects who plan to receive such therapy during study participation;"}, 'identificationModule': {'nctId': 'NCT06703294', 'briefTitle': "A Prospective, Multicenter, Blind, Randomized Controlled, Optimal Clinical Trial to Evaluate the Safety and Efficacy of Medical Collagen Fillers for Facial Dermal Tissue Filling to Correct Frontal Wrinkles (crow's Feet)", 'organization': {'class': 'OTHER', 'fullName': 'Fiman (Changchun) Pharmaceutical Biotechnology Company Limited'}, 'officialTitle': "A Prospective, Multicenter, Blind, Randomized Controlled, Optimal Clinical Trial to Evaluate the Safety and Efficacy of Medical Collagen Fillers for Facial Dermal Tissue Filling to Correct Frontal Wrinkles (crow's Feet)", 'orgStudyIdInfo': {'id': 'FimanPharma'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': "Varying degrees of crow's feet", 'description': "Bovine collagen filling crow's feet", 'interventionNames': ["Procedure: Crow's feet injection filling", "Procedure: Humanized collagen filling crow's feet"]}], 'interventions': [{'name': "Crow's feet injection filling", 'type': 'PROCEDURE', 'description': "Patients with crow's feet of different degree were randomly divided into two groups, which were injected with bovine collagen and humanized collagen respectively", 'armGroupLabels': ["Varying degrees of crow's feet"]}, {'name': "Humanized collagen filling crow's feet", 'type': 'PROCEDURE', 'description': "Bovine collagen filling crow's feet", 'armGroupLabels': ["Varying degrees of crow's feet"]}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Hongqiang Li HQ Li', 'role': 'CONTACT', 'email': 'azhudezhuziyu@163.com', 'phone': '0431-85085090'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fiman (Changchun) Pharmaceutical Biotechnology Company Limited', 'class': 'OTHER'}, 'collaborators': [{'name': "The Seventh Medical Center of the Chinese People's Liberation Army General Hospita", 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}