Aging
Conditions
Keywords
platelet rich plasma, fibrin matrix, dermal filler
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 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.
Interventions
BIOLOGICALPlatelet rich fibrin matrix
Single treatment with platelet rich fibrin matrix
Sponsors
The New York Eye & Ear Infirmary
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* 25 and 75 years of age
Exclusion criteria
* collagen vascular disorders * autoimmune diseases * signs or history of impaired wound healing * shall not have had any infectious or inflammatory processes at the treatment sites within the prior 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 30 Minutes After Treatment With Platelet Rich Fibrin Matrix | 30 minutes after treatment | 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. |
| Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 1 Week After Treatment With Platelet Rich Fibrin Matrix | 1 week after treatment | 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. |
| Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 2 Weeks After Treatment With Platelet Rich Fibrin Matrix | 2 weeks after treatment | 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. |
| Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 6 Weeks After Treatment With Platelet Rich Fibrin Matrix | 6 weeks after treatment | 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. |
| Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 10 Weeks After Treatment With Platelet Rich Fibrin Matrix | 10 weeks after treatment | 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. |
| Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 12 Weeks After Treatment With Platelet Rich Fibrin Matrix | 12 weeks after treatment | 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. |
| Qualitative Changes in Dermal and Sub Dermal Vascularity 30 Minutes After Treatment With Platelet Rich Fibrin Matrix | 30 minutes after treatment | 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. |
| Qualitative Changes in Dermal and Sub Dermal Vascularity 1 Week After Treatment With Platelet Rich Fibrin Matrix | 1 week after treatment | 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. |
| Qualitative Changes in Dermal and Sub Dermal Vascularity 2 Weeks After Treatment With Platelet Rich Fibrin Matrix | 2 weeks after treatment | 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. |
| Qualitative Changes in Dermal and Sub Dermal Vascularity 6 Weeks After Treatment With Platelet Rich Fibrin Matrix | 6 weeks after treatment | 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. |
| Qualitative Changes in Dermal and Sub Dermal Vascularity 10 Weeks After Treatment With Platelet Rich Fibrin Matrix | 10 weeks after treatment | 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. |
| Qualitative Changes in Dermal and Sub Dermal Vascularity 12 Weeks After Treatment With Platelet Rich Fibrin Matrix | 12 weeks after treatment | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies over a 12 week period.
Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix | 4 |
| Total | 4 |
Baseline characteristics
| Characteristic | Treatment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Age, Continuous | 44 years STANDARD_DEVIATION 8 |
| Region of Enrollment United States | 4 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 |
Outcome results
Primary
Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 10 Weeks After Treatment With Platelet Rich Fibrin Matrix
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.
Time frame: 10 weeks after treatment
Population: Each participant will undergo biopsy of skin treated with platelet rich fibrin matrix, at 10 weeks after treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 10 Weeks After Treatment With Platelet Rich Fibrin Matrix | 100 %specimen with >25%new collagen/HPF |
Primary
Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 12 Weeks After Treatment With Platelet Rich Fibrin Matrix
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.
Time frame: 12 weeks after treatment
Population: Each participant will undergo biopsy of skin treated with platelet rich fibrin matrix, at 12 weeks after treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 12 Weeks After Treatment With Platelet Rich Fibrin Matrix | 100 %specimen with >25%new collagen/HPF |
Primary
Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 1 Week After Treatment With Platelet Rich Fibrin Matrix
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.
Time frame: 1 week after treatment
Population: Each participant will undergo biopsy of skin treated with platelet rich fibrin matrix, at 1 week after treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 1 Week After Treatment With Platelet Rich Fibrin Matrix | 100 %specimen with >25%new collagen/HPF |
Primary
Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 2 Weeks After Treatment With Platelet Rich Fibrin Matrix
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.
Time frame: 2 weeks after treatment
Population: Each participant will undergo biopsy of skin treated with platelet rich fibrin matrix, at 2 weeks after treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 2 Weeks After Treatment With Platelet Rich Fibrin Matrix | 100 %specimen with >25%new collagen/HPF |
Primary
Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 30 Minutes After Treatment With Platelet Rich Fibrin Matrix
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.
Time frame: 30 minutes after treatment
Population: Each participant will undergo biopsy of skin treated with platelet rich fibrin matrix, at 30 minutes after treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 30 Minutes After Treatment With Platelet Rich Fibrin Matrix | 0 %specimen with >25%new collagen/HPF |
Primary
Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 6 Weeks After Treatment With Platelet Rich Fibrin Matrix
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.
Time frame: 6 weeks after treatment
Population: Each participant will undergo biopsy of skin treated with platelet rich fibrin matrix, at 6 weeks after treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 6 Weeks After Treatment With Platelet Rich Fibrin Matrix | 100 %specimen with >25%new collagen/HPF |
Primary
Qualitative Changes in Dermal and Sub Dermal Vascularity 10 Weeks After Treatment With Platelet Rich Fibrin Matrix
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.
Time frame: 10 weeks after treatment
Population: Each participant underwent biopsy of skin treated with platelet rich fibrin matrix at 10 weeks.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Qualitative Changes in Dermal and Sub Dermal Vascularity 10 Weeks After Treatment With Platelet Rich Fibrin Matrix | 100 % spec.with>5 immature capillaries/HPF |
Primary
Qualitative Changes in Dermal and Sub Dermal Vascularity 12 Weeks After Treatment With Platelet Rich Fibrin Matrix
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.
Time frame: 12 weeks after treatment
Population: Each participant underwent biopsy of skin treated with platelet rich fibrin matrix at 12 weeks.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Qualitative Changes in Dermal and Sub Dermal Vascularity 12 Weeks After Treatment With Platelet Rich Fibrin Matrix | 50 % spec.with>5 immature capillaries/HPF |
Primary
Qualitative Changes in Dermal and Sub Dermal Vascularity 1 Week After Treatment With Platelet Rich Fibrin Matrix
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.
Time frame: 1 week after treatment
Population: Each participant underwent biopsy of skin treated with platelet rich fibrin matrix at 1 week.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Qualitative Changes in Dermal and Sub Dermal Vascularity 1 Week After Treatment With Platelet Rich Fibrin Matrix | 100 % spec.with>5 immature capillaries/HPF |
Primary
Qualitative Changes in Dermal and Sub Dermal Vascularity 2 Weeks After Treatment With Platelet Rich Fibrin Matrix
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.
Time frame: 2 weeks after treatment
Population: Each participant underwent biopsy of skin treated with platelet rich fibrin matrix at 2 weeks.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Qualitative Changes in Dermal and Sub Dermal Vascularity 2 Weeks After Treatment With Platelet Rich Fibrin Matrix | 100 % spec.with>5 immature capillaries/HPF |
Primary
Qualitative Changes in Dermal and Sub Dermal Vascularity 30 Minutes After Treatment With Platelet Rich Fibrin Matrix
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.
Time frame: 30 minutes after treatment
Population: Each participant underwent biopsy of skin treated with platelet rich fibrin matrix at 30 minutes.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Qualitative Changes in Dermal and Sub Dermal Vascularity 30 Minutes After Treatment With Platelet Rich Fibrin Matrix | 0 % spec.with>5 immature capillaries/HPF |
Primary
Qualitative Changes in Dermal and Sub Dermal Vascularity 6 Weeks After Treatment With Platelet Rich Fibrin Matrix
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.
Time frame: 6 weeks after treatment
Population: Each participant underwent biopsy of skin treated with platelet rich fibrin matrix at 6 weeks.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Qualitative Changes in Dermal and Sub Dermal Vascularity 6 Weeks After Treatment With Platelet Rich Fibrin Matrix | 100 % spec.with>5 immature capillaries/HPF |