Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-28 @ 6:48 PM
Study NCT ID:
NCT05514834
Status:
COMPLETED
Last Update Posted:
2024-04-29
First Post:
2022-07-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BCT-HA Kit for Dehydrated and Wrinkled Skin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The participant, investigator, and dermatopathologist (outcomes assessor) will all be blinded to which group the participant belongs too. Given the color difference of the injected solutions, the syringes with the injection material (HA with PRP or saline) will be masked to prevent the patient or investigator from knowing which material they are injecting.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Blinded, randomized control trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-26', 'studyFirstSubmitDate': '2022-07-25', 'studyFirstSubmitQcDate': '2022-08-23', 'lastUpdatePostDateStruct': {'date': '2024-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Skin Quality Rating Scale', 'timeFrame': 'Week 32', 'description': 'Skin Quality Rating Scale is a 10 point scales used to assess skin quality, including radiance, smoothness, pigmentation, erythema, and pore size.'}, {'measure': 'Change in Global Aesthetic Improvement Scale', 'timeFrame': 'Week 32', 'description': 'This is a 7 point scale to assess degree of improvement of facial skin after treatment.'}, {'measure': 'Change in FACE-Q Score', 'timeFrame': 'Week 32', 'description': 'The following eight FACE-Q scales: (1) satisfaction with overall facial appearance (measures patient satisfaction with the overall appearance of their face); (2) satisfaction with decision (measures patient satisfaction with their decision to undergo the procedure;(3) cheekbones; (4) chin; (5) cheeks; (6) lower face; (7) jawline; and (8) nasolabial folds (items 3 through 8 measure overall and area-specific appearance appraisal to evaluate satisfaction with specific facial areas). Higher FACE-Q scores indicate superior satisfaction'}, {'measure': "Physician's Global assessment to measure quality of life", 'timeFrame': '4 weeks after treatment 1st, 2nd and 3rd treatments and 32 weeks after enrollment', 'description': 'Patient rating of improvement in treated area ranging from 1 to 5, with 5 being worse.'}, {'measure': 'Visual Analog Score for patients', 'timeFrame': 'Immediately after 1st, 2nd and 3rd treatments', 'description': 'Visual analog rating of pain associated with treatment administration ranging between 0 and 10, pain scale.'}, {'measure': 'Wrinkle assessment', 'timeFrame': 'Week 32', 'description': 'Wrinkle Assessment Score is a 9 point scale to asses severity of wrinkles.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['rhytides', 'wrinkles', 'facial aging', 'PRP', 'hyaluronic acid'], 'conditions': ['Rhytides', 'Wrinkle']}, 'descriptionModule': {'briefSummary': 'This study will assess the efficacy of Cellular MatrixTM BCT-HA Kit treatment compared to placebo condition on revitalization and skin rejuvenation on the midface. Particular attention will be made to the safety aspects, as well as the histological consequences of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who are able to give voluntary, written informed consent to participate in this study and from whom consent has been obtained including HIPPA Authorization\n* Healthy men and women, ages 30 - 65 years of age\n* Subjects with Fitzpatrick photo skin type I-VI\n* Subjects with moderate to severe nasolabial folds contour deficiencies or other facial wrinkles. Degree of nasolabial folds or other facial wrinkles will be determined on the basis of the Wrinkles Severity Rating Scale\n* Subjects who agree not to have any other procedures of affecting skin quality (microdermabrasion, peels, acne treatments, toxin, fillers etc.) for the duration of the study\n* Subjects who understand the study and are able to follow study instructions and are willing to attend the required study visits.\n* Subjects who agree to be photographed for research purposes and their identity may not be concealed in these photographs.\n\nExclusion Criteria:\n\n* Subjects who have had any kind of aesthetic therapy (peeling, laser, ultrasound, toxins, fillers) in the facial area during the last 6 months\n* Presence of implant in the facial area to treat\n* Contraindications to the use of antiseptics (Biseptine, Amukine)\n* Subjects who have an active or known skin inflammation or infection within the treatment area.\n* Subjects who have an active or known acute skin allergies\n* Subjects who have a known allergy to hyaluronic acid\n* Subjects who have any other dermatologic conditions including acne, rosacea, eczema, psoriasis, actinic keratosis, severe sun damage, infection, or scars within the treatment area.\n* Subjects of child-bearing potential who are not using an approved method of birth control (oral contraceptives, IUD, contraceptive implant, barrier methods with spermicide or abstinence). Females of non-childbearing potential are defined as post-menopausal (absence of menstrual bleeding for one year), hysterectomy, or bilateral oophorectomy.\n* Subjects who are pregnant, planning to become pregnant or breastfeeding. A urine pregnancy test will be done to rule out pregnancy.\n* Subjects who have been diagnosed with diabetes\n* Subjects who are Immunosuppressed\n* Subjects who are HIV+ / VHB+ / VHC+\n* Subjects who have had/will have a COVID vaccine within 2 weeks of study participation\n* Subjects who have had/will have a dental procedure within 4 weeks of study participation\n* Subjects with a history of severe bee allergy'}, 'identificationModule': {'nctId': 'NCT05514834', 'briefTitle': 'BCT-HA Kit for Dehydrated and Wrinkled Skin', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Feasibility Study to Evaluate the Safety and Efficacy of Cellular MAtrix™ BCT-HA Kit as a New Treatment Option for Dehydrated and Wrinkled Skin (A Clinical and Histological Evaluation)', 'orgStudyIdInfo': {'id': 'DERM-2021-30292'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'combined HA with PRP', 'description': 'Hyaluronic acid and PRP combination treatment', 'interventionNames': ['Device: Cellular Matrix TM BCT-HA Kit (ref. BCT-HA-3)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'saline solution', 'interventionNames': ['Other: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PRP', 'description': 'Platelet rich plasma without hyaluronic acid', 'interventionNames': ['Other: PRP Only']}], 'interventions': [{'name': 'Cellular Matrix TM BCT-HA Kit (ref. BCT-HA-3)', 'type': 'DEVICE', 'description': 'Injections with platelet-rich plasma and hyaluronic acid', 'armGroupLabels': ['combined HA with PRP']}, {'name': 'PRP Only', 'type': 'OTHER', 'description': 'platelet rich plasma without hyaluronic acid', 'armGroupLabels': ['PRP']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Neither PRP nor hyaluronic acid', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Maria Hordinsky, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}