Trial Outcomes & Findings for Evaluation of the Mechanism of Action of Platelet Rich Fibrin Matrix (PRFM) in Producing Skin Volume Augmentation (NCT NCT00956020)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

4 participants

Primary outcome timeframe

30 minutes after treatment

Results posted on

2015-12-16

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	4
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of the Mechanism of Action of Platelet Rich Fibrin Matrix (PRFM) in Producing Skin Volume Augmentation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment n=4 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	44 years STANDARD_DEVIATION 8 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 minutes after treatment

Population: Each participant will undergo biopsy of skin treated with platelet rich fibrin matrix, at 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.

Outcome measures

Outcome measures
Measure	Treatment n=4 skin biopsy specimen 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. Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix
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 outcome

Timeframe: 1 week after treatment

Population: Each participant will undergo biopsy of skin treated with platelet rich fibrin matrix, at 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.

Outcome measures

Outcome measures
Measure	Treatment n=3 Skin biopsy specimen 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. Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix
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 outcome

Timeframe: 2 weeks after treatment

Population: Each participant will undergo biopsy of skin treated with platelet rich fibrin matrix, at 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.

Outcome measures

Outcome measures
Measure	Treatment n=2 skin biopsy specimen 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. Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix
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 outcome

Timeframe: 6 weeks after treatment

Population: Each participant will undergo biopsy of skin treated with platelet rich fibrin matrix, at 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.

Outcome measures

Outcome measures
Measure	Treatment n=3 Skin biopsy specimen 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. Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix
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 outcome

Timeframe: 10 weeks after treatment

Population: Each participant will undergo biopsy of skin treated with platelet rich fibrin matrix, at 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.

Outcome measures

Outcome measures
Measure	Treatment n=2 Participants 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. Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix
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 outcome

Timeframe: 12 weeks after treatment

Population: Each participant will undergo biopsy of skin treated with platelet rich fibrin matrix, at 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.

Outcome measures

Outcome measures
Measure	Treatment n=2 Participants 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. Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix
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 outcome

Timeframe: 30 minutes after treatment

Population: Each participant underwent biopsy of skin treated with platelet rich fibrin matrix at 30 minutes.

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.

Outcome measures

Outcome measures
Measure	Treatment n=4 Skin biopsy specimen 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. Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix
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 outcome

Timeframe: 1 week after treatment

Population: Each participant underwent biopsy of skin treated with platelet rich fibrin matrix at 1 week.

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.

Outcome measures

Outcome measures
Measure	Treatment n=3 Participants 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. Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix
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 outcome

Timeframe: 2 weeks after treatment

Population: Each participant underwent biopsy of skin treated with platelet rich fibrin matrix at 2 weeks.

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.

Outcome measures

Outcome measures
Measure	Treatment n=2 Participants 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. Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix
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 outcome

Timeframe: 6 weeks after treatment

Population: Each participant underwent biopsy of skin treated with platelet rich fibrin matrix at 6 weeks.

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.

Outcome measures

Outcome measures
Measure	Treatment n=3 Participants 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. Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix
Qualitative Changes in Dermal and Sub Dermal Vascularity 6 Weeks After Treatment With Platelet Rich Fibrin Matrix	100 % spec.with>5 immature capillaries/HPF

PRIMARY outcome

Timeframe: 10 weeks after treatment

Population: Each participant underwent biopsy of skin treated with platelet rich fibrin matrix at 10 weeks.

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.

Outcome measures

Outcome measures
Measure	Treatment n=2 Participants 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. Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix
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 outcome

Timeframe: 12 weeks after treatment

Population: Each participant underwent biopsy of skin treated with platelet rich fibrin matrix at 12 weeks.

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.

Outcome measures

Outcome measures
Measure	Treatment n=2 Participants 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. Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix
Qualitative Changes in Dermal and Sub Dermal Vascularity 12 Weeks After Treatment With Platelet Rich Fibrin Matrix	50 % spec.with>5 immature capillaries/HPF

Adverse Events

Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Anthony Sclafani, MD

NYEEI Department of Otolaryngology

Phone: 212-979-4200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place