Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-26 @ 1:56 AM
Study NCT ID:
NCT00874094
Status:
COMPLETED
Last Update Posted:
2013-07-12
First Post:
2009-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pilot Evaluation of Platelet Rich Fibrin Matrix (PRFM) for the Correction of Nasolabial Folds
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'asclafani@nyee.edu', 'phone': '212-979-4200', 'title': 'Anthony P Sclafani, MD', 'organization': 'NY Eye & Ear Infirmary'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Treatment With Platelet Rich Fibrin Matrix', 'description': 'Both nasolabial folds treated with platelet rich fibrin matrix', 'otherNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Difference in Wrinkle Assessment Score, Between Pre-treatment and 12 Weeks Post-treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment With Platelet Rich Fibrin Matrix', 'description': 'Both nasolabial folds treated with platelet rich fibrin matrix'}], 'classes': [{'categories': [{'measurements': [{'value': '1.13', 'spread': '0.76', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Difference in Measurements taken Pre-treatment and 12 weeks after treatment.', 'description': 'Difference in wrinkle assessment score, values ranging from 0 (least noticeable) to 5 ( most noticeable) (scores on a scale)between pre-treatment and 12 weeks post-treatment.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants were calculated based on need to achieve 1 unit improvement of Wrinkle Assessment score over baseline (pre-treatment) to be clinically relevant.'}, {'type': 'SECONDARY', 'title': 'Difference in Wrinkle Assessment Scores Between Pre-treatment and 1 Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment With Platelet Rich Fibrin Matrix', 'description': 'Both nasolabial folds treated with platelet rich fibrin matrix'}], 'classes': [{'categories': [{'measurements': [{'value': '.65', 'spread': '.68', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-treatment to 1 week after treatment', 'description': 'Difference in Wrinkle Assessment Scores, values ranging from 0 (least noticeable) to 5 ( most noticeable) (scores on a scale), between Pre-treatment and 1 week', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants required to demonstrate a 1 point difference between pre and post treatment values'}, {'type': 'SECONDARY', 'title': 'Difference in Wrinkle Assessment Score Between Pretreatment and 2 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment With Platelet Rich Fibrin Matrix', 'description': 'Both nasolabial folds treated with platelet rich fibrin matrix'}], 'classes': [{'categories': [{'measurements': [{'value': '.97', 'spread': '.75', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-treatment to 2 weeks after treatment', 'description': 'Difference in Wrinkle Assessment Scores, values ranging from 0 (least noticeable) to 5 ( most noticeable) (scores on a scale), between Pre-treatment and 2 weeks', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Difference in Wrinkle Assessment Score Between Pretreatment and 6 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment With Platelet Rich Fibrin Matrix', 'description': 'Both nasolabial folds treated with platelet rich fibrin matrix'}], 'classes': [{'categories': [{'measurements': [{'value': '1.08', 'spread': '.59', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-treatment to 6 weeks after treatment', 'description': 'Difference in Wrinkle Assessment Scores, values ranging from 0 (least noticeable) to 5 ( most noticeable) (scores on a scale), between Pre-treatment and 6 Weeks', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment With Platelet Rich Fibrin Matrix', 'description': 'Both nasolabial folds treated with platelet rich fibrin matrix'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Patients with moderate to severe nasolabial folds were included.', 'preAssignmentDetails': 'Any patient who refused to attend all scheduled follow up visits were to be excluded.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment With Platelet Rich Fibrin Matrix', 'description': 'Both nasolabial folds treated with platelet rich fibrin matrix'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.27', 'spread': '12.11', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-10', 'studyFirstSubmitDate': '2009-04-01', 'resultsFirstSubmitDate': '2011-07-18', 'studyFirstSubmitQcDate': '2009-04-01', 'lastUpdatePostDateStruct': {'date': '2013-07-12', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-07-10', 'studyFirstPostDateStruct': {'date': '2009-04-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-07-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in Wrinkle Assessment Score, Between Pre-treatment and 12 Weeks Post-treatment.', 'timeFrame': 'Difference in Measurements taken Pre-treatment and 12 weeks after treatment.', 'description': 'Difference in wrinkle assessment score, values ranging from 0 (least noticeable) to 5 ( most noticeable) (scores on a scale)between pre-treatment and 12 weeks post-treatment.'}], 'secondaryOutcomes': [{'measure': 'Difference in Wrinkle Assessment Scores Between Pre-treatment and 1 Week', 'timeFrame': 'pre-treatment to 1 week after treatment', 'description': 'Difference in Wrinkle Assessment Scores, values ranging from 0 (least noticeable) to 5 ( most noticeable) (scores on a scale), between Pre-treatment and 1 week'}, {'measure': 'Difference in Wrinkle Assessment Score Between Pretreatment and 2 Weeks', 'timeFrame': 'Pre-treatment to 2 weeks after treatment', 'description': 'Difference in Wrinkle Assessment Scores, values ranging from 0 (least noticeable) to 5 ( most noticeable) (scores on a scale), between Pre-treatment and 2 weeks'}, {'measure': 'Difference in Wrinkle Assessment Score Between Pretreatment and 6 Weeks', 'timeFrame': 'Pre-treatment to 6 weeks after treatment', 'description': 'Difference in Wrinkle Assessment Scores, values ranging from 0 (least noticeable) to 5 ( most noticeable) (scores on a scale), between Pre-treatment and 6 Weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['nasolabial folds', 'platelet rich plasma', 'fibrin matrix', 'facial rhytids', 'dermal filler'], 'conditions': ['Nasolabial Folds']}, 'referencesModule': {'references': [{'pmid': '20367676', 'type': 'RESULT', 'citation': 'Sclafani AP. Platelet-rich fibrin matrix for improvement of deep nasolabial folds. J Cosmet Dermatol. 2010 Mar;9(1):66-71. doi: 10.1111/j.1473-2165.2010.00486.x.'}]}, 'descriptionModule': {'briefSummary': "Platelets are a component of blood, which contain factors which can enhance wound healing. This study proposes to evaluate the clinical response of laugh lines treated with a concentrated preparation of the subject's own platelets injected into or under the skin by taking serial photographs of the subject's face over a 12 week period. Also, the same preparation will be injected into or under the skin of the arm near the elbows, and serial biopsies will be taken over a 12 week period."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy adults\n* aged 25- 75 years\n* with moderate to severe nasolabial folds\n\nExclusion Criteria:\n\n* pregnant\n* allergy to local anesthetics\n* history of bleeding disorder\n* active infection at the treatment site\n* injectable filler in the nasolabial folds within past year'}, 'identificationModule': {'nctId': 'NCT00874094', 'briefTitle': 'Pilot Evaluation of Platelet Rich Fibrin Matrix (PRFM) for the Correction of Nasolabial Folds', 'organization': {'class': 'OTHER', 'fullName': 'The New York Eye & Ear Infirmary'}, 'officialTitle': 'Pilot Evaluation of Platelet Rich Fibrin Matrix (PRFM) for the Correction of Nasolabial Folds', 'orgStudyIdInfo': {'id': '08.01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'platelet rich fibrin matrix', 'description': 'Both nasolabial folds treated with 0-2 cc of autologous platelet rich fibrin matrix,sufficient to efface nasolabial fold', 'interventionNames': ['Biological: Platelet rich fibrin matrix']}], 'interventions': [{'name': 'Platelet rich fibrin matrix', 'type': 'BIOLOGICAL', 'description': '0-2 cc of autologous platelet rich fibrin matrix injected intra and subdermally to effect nasolabial fold.', 'armGroupLabels': ['platelet rich fibrin matrix']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10514', 'city': 'Chappaqua', 'state': 'New York', 'country': 'United States', 'facility': 'The New York Eye & Ear Infirmary- Otolaryngology Faculty practice satellite', 'geoPoint': {'lat': 41.15954, 'lon': -73.76485}}], 'overallOfficials': [{'name': 'Anthony P Sclafani, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The New York Eye & Ear Infirmary'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The New York Eye & Ear Infirmary', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}