Evaluation of the Mechanism of Action of Platelet Rich Fibrin Matrix (PRFM) in Producing Skin Volume Augmentation
This study has been completed.
Sponsor:
The New York Eye & Ear Infirmary
Information provided by (Responsible Party):
Anthony P. Sclafani, The New York Eye & Ear Infirmary
ClinicalTrials.gov Identifier:
NCT00956020
First received: August 10, 2009
Last updated: April 29, 2012
Last verified: April 2012
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | August 10, 2009 | ||||
| Last Updated Date | April 29, 2012 | ||||
| Start Date ICMJE | October 2009 | ||||
| Primary Completion Date | February 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Changes in dermal and subdermal protein content after treatment with platelet rich fibrin matrix compared to control specimen [ Time Frame: 12 weeks ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00956020 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Changes in local skin blood flow after treatment with platelet rich fibrin matrix [ Time Frame: 12 weeks ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Evaluation of the Mechanism of Action of Platelet Rich Fibrin Matrix (PRFM) in Producing Skin Volume Augmentation | ||||
| Official Title ICMJE | Evaluation of the Mechanism of Action of Platelet Rich Fibrin Matrix (PRFM) in Producing Skin Volume Augmentation | ||||
| Brief Summary | 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. |
||||
| Detailed Description | 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 over a 12 week period. Specimen of treated and control areas will undergo histologic and biochemical analysis and comparison. |
||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 Phase 2 |
||||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
||||
| Condition ICMJE | Facial Rhytids | ||||
| Intervention ICMJE | Biological: Platelet rich fibrin matrix
Single treatment with platelet rich fibrin matrix
Other Name: Selphyl |
||||
| Study Arm (s) | Experimental: Treatment
Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies over a 12 week period.
Intervention: Biological: Platelet rich fibrin matrix |
||||
| Publications * | 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;14(2):132-6. Epub 2011 Oct 17. | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 5 | ||||
| Completion Date | July 2011 | ||||
| Primary Completion Date | February 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 25 Years to 75 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00956020 | ||||
| Other Study ID Numbers ICMJE | 09-01 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Anthony P. Sclafani, The New York Eye & Ear Infirmary | ||||
| Study Sponsor ICMJE | The New York Eye & Ear Infirmary | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | The New York Eye & Ear Infirmary | ||||
| Verification Date | April 2012 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||