Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT00956020
Status:
COMPLETED
Last Update Posted:
2015-12-16
First Post:
2009-08-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Evaluation of the Mechanism of Action of Platelet Rich Fibrin Matrix (PRFM) in Producing Skin Volume Augmentation
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 Sclafani, MD', 'organization': 'NYEEI Department of Otolaryngology'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '3 months', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment', 'description': 'Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies over a 12 week period.\n\nPlatelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix', 'otherNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'seriousNumAffected': 0}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 30 Minutes After Treatment With Platelet Rich Fibrin Matrix', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}, {'units': 'skin biopsy specimen', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies over a period from 30 minutes to 12 weeks after treatment.\n\nPlatelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 minutes after treatment', 'description': 'Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H\\&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal collagen (as determined by the number of specimen which had greater than 25% new collagen deposition per high powered field) 30 minutes after treatment with platelet rich fibrin matrix will be reported. The results were characterize the general qualitative changes and time frame for the effects of treatment.', 'unitOfMeasure': '%specimen with >25%new collagen/HPF', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'skin biopsy specimen', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Each participant will undergo biopsy of skin treated with platelet rich fibrin matrix, at 30 minutes after treatment.'}, {'type': 'PRIMARY', 'title': 'Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 1 Week After Treatment With Platelet Rich Fibrin Matrix', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}, {'units': 'Skin biopsy specimen', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies 1 week after treatment.\n\nPlatelet rich fibrin matrix: Single treatment with platelet rich fibrin matrix'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 week after treatment', 'description': 'Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H\\&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal collagen (as determined by the number of specimen which had greater than 25% new collagen deposition per high powered field) 1 week after treatment with platelet rich fibrin matrix will be reported. The results were characterize the general qualitative changes and time frame for the effects of treatment.', 'unitOfMeasure': '%specimen with >25%new collagen/HPF', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Skin biopsy specimen', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Each participant will undergo biopsy of skin treated with platelet rich fibrin matrix, at 1 week after treatment.'}, {'type': 'PRIMARY', 'title': 'Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 2 Weeks After Treatment With Platelet Rich Fibrin Matrix', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}, {'units': 'skin biopsy specimen', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies 2 weeks after treatment.\n\nPlatelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 weeks after treatment', 'description': 'Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H\\&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal collagen (as determined by the number of specimen which had greater than 25% new collagen deposition per high powered field) 2 weeks after treatment with platelet rich fibrin matrix will be reported. The results were characterize the general qualitative changes and time frame for the effects of treatment.', 'unitOfMeasure': '%specimen with >25%new collagen/HPF', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'skin biopsy specimen', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Each participant will undergo biopsy of skin treated with platelet rich fibrin matrix, at 2 weeks after treatment.'}, {'type': 'PRIMARY', 'title': 'Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 6 Weeks After Treatment With Platelet Rich Fibrin Matrix', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}, {'units': 'Skin biopsy specimen', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies 6 weeks after treatment.\n\nPlatelet rich fibrin matrix: Single treatment with platelet rich fibrin matrix'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks after treatment', 'description': 'Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H\\&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal collagen (as determined by the number of specimen which had greater than 25% new collagen deposition per high powered field) 6 weeks after treatment with platelet rich fibrin matrix will be reported. The results were characterize the general qualitative changes and time frame for the effects of treatment.', 'unitOfMeasure': '%specimen with >25%new collagen/HPF', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Skin biopsy specimen', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Each participant will undergo biopsy of skin treated with platelet rich fibrin matrix, at 6 weeks after treatment.'}, {'type': 'PRIMARY', 'title': 'Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 10 Weeks After Treatment With Platelet Rich Fibrin Matrix', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies 10 weeks after treatment.\n\nPlatelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '10 weeks after treatment', 'description': 'Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H\\&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal collagen (as determined by the number of specimen which had greater than 25% new collagen deposition per high powered field) 10 weeks after treatment with platelet rich fibrin matrix will be reported. The results were characterize the general qualitative changes and time frame for the effects of treatment.', 'unitOfMeasure': '%specimen with >25%new collagen/HPF', 'reportingStatus': 'POSTED', 'populationDescription': 'Each participant will undergo biopsy of skin treated with platelet rich fibrin matrix, at 10 weeks after treatment.'}, {'type': 'PRIMARY', 'title': 'Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 12 Weeks After Treatment With Platelet Rich Fibrin Matrix', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies 12 weeks after treatment.\n\nPlatelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks after treatment', 'description': 'Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H\\&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal collagen (as determined by the number of specimen which had greater than 25% new collagen deposition per high powered field) 12 weeks after treatment with platelet rich fibrin matrix will be reported. The results were characterize the general qualitative changes and time frame for the effects of treatment.', 'unitOfMeasure': '%specimen with >25%new collagen/HPF', 'reportingStatus': 'POSTED', 'populationDescription': 'Each participant will undergo biopsy of skin treated with platelet rich fibrin matrix, at 12 weeks after treatment.'}, {'type': 'PRIMARY', 'title': 'Qualitative Changes in Dermal and Sub Dermal Vascularity 30 Minutes After Treatment With Platelet Rich Fibrin Matrix', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}, {'units': 'Skin biopsy specimen', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies 30 minutes after treatment.\n\nPlatelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 minutes after treatment', 'description': 'Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H\\&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal vascularity (as determined by the the number of specimen with greater than 5 immature capillaries per high powered field) after treatment with platelet rich fibrin matrix will be reported. Individual treated specimen were evaluated at 30 minutes after treatment, and the results used to determine the general qualitative changes and time frame for the effects of treatment.', 'unitOfMeasure': '% spec.with>5 immature capillaries/HPF', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Skin biopsy specimen', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Each participant underwent biopsy of skin treated with platelet rich fibrin matrix at 30 minutes.'}, {'type': 'PRIMARY', 'title': 'Qualitative Changes in Dermal and Sub Dermal Vascularity 1 Week After Treatment With Platelet Rich Fibrin Matrix', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies 1 week after treatment.\n\nPlatelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 week after treatment', 'description': 'Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H\\&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal vascularity (as determined by the the number of specimen with greater than 5 immature capillaries per high powered field) after treatment with platelet rich fibrin matrix will be reported. Individual treated specimen were evaluated at 1 week after treatment, and the results used to determine the general qualitative changes and time frame for the effects of treatment.', 'unitOfMeasure': '% spec.with>5 immature capillaries/HPF', 'reportingStatus': 'POSTED', 'populationDescription': 'Each participant underwent biopsy of skin treated with platelet rich fibrin matrix at 1 week.'}, {'type': 'PRIMARY', 'title': 'Qualitative Changes in Dermal and Sub Dermal Vascularity 2 Weeks After Treatment With Platelet Rich Fibrin Matrix', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies 2 week after treatment.\n\nPlatelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 weeks after treatment', 'description': 'Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H\\&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal vascularity (as determined by the number of specimen with greater than 5 immature capillaries per high powered field) after treatment with platelet rich fibrin matrix will be reported. Individual treated specimen were evaluated at 2 weeks after treatment, and the results used to determine the general qualitative changes and time frame for the effects of treatment.', 'unitOfMeasure': '% spec.with>5 immature capillaries/HPF', 'reportingStatus': 'POSTED', 'populationDescription': 'Each participant underwent biopsy of skin treated with platelet rich fibrin matrix at 2 weeks.'}, {'type': 'PRIMARY', 'title': 'Qualitative Changes in Dermal and Sub Dermal Vascularity 6 Weeks After Treatment With Platelet Rich Fibrin Matrix', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies 6 weeks after treatment.\n\nPlatelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks after treatment', 'description': 'Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H\\&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal vascularity (as determined by the number of specimen with greater than 5 immature capillaries per high powered field) after treatment with platelet rich fibrin matrix will be reported. Individual treated specimen were evaluated at 6 weeks after treatment, and the results used to determine the general qualitative changes and time frame for the effects of treatment.', 'unitOfMeasure': '% spec.with>5 immature capillaries/HPF', 'reportingStatus': 'POSTED', 'populationDescription': 'Each participant underwent biopsy of skin treated with platelet rich fibrin matrix at 6 weeks.'}, {'type': 'PRIMARY', 'title': 'Qualitative Changes in Dermal and Sub Dermal Vascularity 10 Weeks After Treatment With Platelet Rich Fibrin Matrix', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies 10 weeks after treatment.\n\nPlatelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '10 weeks after treatment', 'description': 'Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H\\&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal vascularity (as determined by the number of specimen with greater than 5 immature capillaries per high powered field) after treatment with platelet rich fibrin matrix will be reported. Individual treated specimen were evaluated at 10 weeks after treatment, and the results used to determine the general qualitative changes and time frame for the effects of treatment.', 'unitOfMeasure': '% spec.with>5 immature capillaries/HPF', 'reportingStatus': 'POSTED', 'populationDescription': 'Each participant underwent biopsy of skin treated with platelet rich fibrin matrix at 10 weeks.'}, {'type': 'PRIMARY', 'title': 'Qualitative Changes in Dermal and Sub Dermal Vascularity 12 Weeks After Treatment With Platelet Rich Fibrin Matrix', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies 12 weeks after treatment.\n\nPlatelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix'}], 'classes': [{'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks after treatment', 'description': 'Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H\\&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal vascularity (as determined by the number of specimen with greater than 5 immature capillaries per high powered field) after treatment with platelet rich fibrin matrix will be reported. Individual treated specimen were evaluated at 12 weeks after treatment, and the results used to determine the general qualitative changes and time frame for the effects of treatment.', 'unitOfMeasure': '% spec.with>5 immature capillaries/HPF', 'reportingStatus': 'POSTED', 'populationDescription': 'Each participant underwent biopsy of skin treated with platelet rich fibrin matrix at 12 weeks.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment', 'description': 'Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies over a 12 week period.\n\nPlatelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment', 'description': 'Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies over a 12 week period.\n\nPlatelet rich fibrin matrix : Single treatment 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': '4', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44', 'spread': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', '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': '4', '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': 4}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-11', 'studyFirstSubmitDate': '2009-08-10', 'resultsFirstSubmitDate': '2013-05-02', 'studyFirstSubmitQcDate': '2009-08-10', 'lastUpdatePostDateStruct': {'date': '2015-12-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-11-11', 'studyFirstPostDateStruct': {'date': '2009-08-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 30 Minutes After Treatment With Platelet Rich Fibrin Matrix', 'timeFrame': '30 minutes after treatment', 'description': 'Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H\\&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal collagen (as determined by the number of specimen which had greater than 25% new collagen deposition per high powered field) 30 minutes after treatment with platelet rich fibrin matrix will be reported. The results were characterize the general qualitative changes and time frame for the effects of treatment.'}, {'measure': 'Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 1 Week After Treatment With Platelet Rich Fibrin Matrix', 'timeFrame': '1 week after treatment', 'description': 'Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H\\&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal collagen (as determined by the number of specimen which had greater than 25% new collagen deposition per high powered field) 1 week after treatment with platelet rich fibrin matrix will be reported. The results were characterize the general qualitative changes and time frame for the effects of treatment.'}, {'measure': 'Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 2 Weeks After Treatment With Platelet Rich Fibrin Matrix', 'timeFrame': '2 weeks after treatment', 'description': 'Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H\\&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal collagen (as determined by the number of specimen which had greater than 25% new collagen deposition per high powered field) 2 weeks after treatment with platelet rich fibrin matrix will be reported. The results were characterize the general qualitative changes and time frame for the effects of treatment.'}, {'measure': 'Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 6 Weeks After Treatment With Platelet Rich Fibrin Matrix', 'timeFrame': '6 weeks after treatment', 'description': 'Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H\\&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal collagen (as determined by the number of specimen which had greater than 25% new collagen deposition per high powered field) 6 weeks after treatment with platelet rich fibrin matrix will be reported. The results were characterize the general qualitative changes and time frame for the effects of treatment.'}, {'measure': 'Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 10 Weeks After Treatment With Platelet Rich Fibrin Matrix', 'timeFrame': '10 weeks after treatment', 'description': 'Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H\\&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal collagen (as determined by the number of specimen which had greater than 25% new collagen deposition per high powered field) 10 weeks after treatment with platelet rich fibrin matrix will be reported. The results were characterize the general qualitative changes and time frame for the effects of treatment.'}, {'measure': 'Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 12 Weeks After Treatment With Platelet Rich Fibrin Matrix', 'timeFrame': '12 weeks after treatment', 'description': 'Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H\\&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal collagen (as determined by the number of specimen which had greater than 25% new collagen deposition per high powered field) 12 weeks after treatment with platelet rich fibrin matrix will be reported. The results were characterize the general qualitative changes and time frame for the effects of treatment.'}, {'measure': 'Qualitative Changes in Dermal and Sub Dermal Vascularity 30 Minutes After Treatment With Platelet Rich Fibrin Matrix', 'timeFrame': '30 minutes after treatment', 'description': 'Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H\\&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal vascularity (as determined by the the number of specimen with greater than 5 immature capillaries per high powered field) after treatment with platelet rich fibrin matrix will be reported. Individual treated specimen were evaluated at 30 minutes after treatment, and the results used to determine the general qualitative changes and time frame for the effects of treatment.'}, {'measure': 'Qualitative Changes in Dermal and Sub Dermal Vascularity 1 Week After Treatment With Platelet Rich Fibrin Matrix', 'timeFrame': '1 week after treatment', 'description': 'Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H\\&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal vascularity (as determined by the the number of specimen with greater than 5 immature capillaries per high powered field) after treatment with platelet rich fibrin matrix will be reported. Individual treated specimen were evaluated at 1 week after treatment, and the results used to determine the general qualitative changes and time frame for the effects of treatment.'}, {'measure': 'Qualitative Changes in Dermal and Sub Dermal Vascularity 2 Weeks After Treatment With Platelet Rich Fibrin Matrix', 'timeFrame': '2 weeks after treatment', 'description': 'Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H\\&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal vascularity (as determined by the number of specimen with greater than 5 immature capillaries per high powered field) after treatment with platelet rich fibrin matrix will be reported. Individual treated specimen were evaluated at 2 weeks after treatment, and the results used to determine the general qualitative changes and time frame for the effects of treatment.'}, {'measure': 'Qualitative Changes in Dermal and Sub Dermal Vascularity 6 Weeks After Treatment With Platelet Rich Fibrin Matrix', 'timeFrame': '6 weeks after treatment', 'description': 'Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H\\&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal vascularity (as determined by the number of specimen with greater than 5 immature capillaries per high powered field) after treatment with platelet rich fibrin matrix will be reported. Individual treated specimen were evaluated at 6 weeks after treatment, and the results used to determine the general qualitative changes and time frame for the effects of treatment.'}, {'measure': 'Qualitative Changes in Dermal and Sub Dermal Vascularity 10 Weeks After Treatment With Platelet Rich Fibrin Matrix', 'timeFrame': '10 weeks after treatment', 'description': 'Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H\\&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal vascularity (as determined by the number of specimen with greater than 5 immature capillaries per high powered field) after treatment with platelet rich fibrin matrix will be reported. Individual treated specimen were evaluated at 10 weeks after treatment, and the results used to determine the general qualitative changes and time frame for the effects of treatment.'}, {'measure': 'Qualitative Changes in Dermal and Sub Dermal Vascularity 12 Weeks After Treatment With Platelet Rich Fibrin Matrix', 'timeFrame': '12 weeks after treatment', 'description': 'Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H\\&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal vascularity (as determined by the number of specimen with greater than 5 immature capillaries per high powered field) after treatment with platelet rich fibrin matrix will be reported. Individual treated specimen were evaluated at 12 weeks after treatment, and the results used to determine the general qualitative changes and time frame for the effects of treatment.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['platelet rich plasma', 'fibrin matrix', 'dermal filler'], 'conditions': ['Aging']}, 'referencesModule': {'references': [{'pmid': '22006233', 'type': 'RESULT', 'citation': 'Sclafani AP, McCormick SA. Induction of dermal collagenesis, angiogenesis, and adipogenesis in human skin by injection of platelet-rich fibrin matrix. Arch Facial Plast Surg. 2012 Mar-Apr;14(2):132-6. doi: 10.1001/archfacial.2011.784. Epub 2011 Oct 17.'}]}, 'descriptionModule': {'briefSummary': 'Autologous platelet rich fibrin matrix will release growth factors which could increase the production of dermal proteins or affect the vascularity and status of neighboring tissues. This study is designed to evaluate the histologic and biochemical effect of injection of platelet rich fibrin matrix into the skin.', 'detailedDescription': 'Subjects will be treated with platelet rich fibrin matrix into the skin of the inner aspect of the upper arm. Injected areas will be monitored clinically and will also undergo biopsies between 30 minutes and 12 weeks after treatment. Specimen of treated areas will undergo histologic and biochemical analysis and comparison to standard laboratory control specimen of untreated skin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 25 and 75 years of age\n\nExclusion Criteria:\n\n* collagen vascular disorders\n* autoimmune diseases\n* signs or history of impaired wound healing\n* shall not have had any infectious or inflammatory processes at the treatment sites within the prior 6 months'}, 'identificationModule': {'nctId': 'NCT00956020', 'briefTitle': 'Evaluation of the Mechanism of Action of Platelet Rich Fibrin Matrix (PRFM) in Producing Skin Volume Augmentation', 'organization': {'class': 'OTHER', 'fullName': 'The New York Eye & Ear Infirmary'}, 'officialTitle': 'Evaluation of the Mechanism of Action of Platelet Rich Fibrin Matrix (PRFM) in Producing Skin Volume Augmentation', 'orgStudyIdInfo': {'id': '09-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies over a period from 30 minutes to 12 weeks after treatment.', 'interventionNames': ['Biological: Platelet rich fibrin matrix']}], 'interventions': [{'name': 'Platelet rich fibrin matrix', 'type': 'BIOLOGICAL', 'otherNames': ['Selphyl'], 'description': 'Single treatment with platelet rich fibrin matrix', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10003', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'The NY Eye & Ear Infirmary', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Anthony P Sclafani, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The NY Eye & Ear Infirmary'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The New York Eye & Ear Infirmary', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Facial Plastic Surgery', 'investigatorFullName': 'Anthony P. Sclafani', 'investigatorAffiliation': 'The New York Eye & Ear Infirmary'}}}}