Trial Outcomes & Findings for Pilot Evaluation of Platelet Rich Fibrin Matrix (PRFM) for the Correction of Nasolabial Folds (NCT NCT00874094)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

15 participants

Primary outcome timeframe

Difference in Measurements taken Pre-treatment and 12 weeks after treatment.

Results posted on

2013-07-12

Participant Flow

Patients with moderate to severe nasolabial folds were included.

Any patient who refused to attend all scheduled follow up visits were to be excluded.

Participant milestones

Participant milestones
Measure	Treatment With Platelet Rich Fibrin Matrix Both nasolabial folds treated with platelet rich fibrin matrix
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pilot Evaluation of Platelet Rich Fibrin Matrix (PRFM) for the Correction of Nasolabial Folds

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment With Platelet Rich Fibrin Matrix n=15 Participants Both nasolabial folds treated with platelet rich fibrin matrix
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=99 Participants
Age, Categorical >=65 years	1 Participants n=99 Participants
Age Continuous	54.27 years STANDARD_DEVIATION 12.11 • n=99 Participants
Sex: Female, Male Female	13 Participants n=99 Participants
Sex: Female, Male Male	2 Participants n=99 Participants
Region of Enrollment United States	15 participants n=99 Participants

PRIMARY outcome

Timeframe: Difference in Measurements taken Pre-treatment and 12 weeks after treatment.

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Treatment With Platelet Rich Fibrin Matrix n=15 Participants Both nasolabial folds treated with platelet rich fibrin matrix
Difference in Wrinkle Assessment Score, Between Pre-treatment and 12 Weeks Post-treatment.	1.13 units on a scale Standard Deviation 0.76

SECONDARY outcome

Timeframe: pre-treatment to 1 week after treatment

Population: The number of participants required to demonstrate a 1 point difference between pre and post treatment values

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

Outcome measures

Outcome measures
Measure	Treatment With Platelet Rich Fibrin Matrix n=15 Participants Both nasolabial folds treated with platelet rich fibrin matrix
Difference in Wrinkle Assessment Scores Between Pre-treatment and 1 Week	.65 units on a scale Standard Deviation .68

SECONDARY outcome

Timeframe: Pre-treatment to 2 weeks after treatment

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

Outcome measures

Outcome measures
Measure	Treatment With Platelet Rich Fibrin Matrix n=15 Participants Both nasolabial folds treated with platelet rich fibrin matrix
Difference in Wrinkle Assessment Score Between Pretreatment and 2 Weeks	.97 units on a scale Standard Deviation .75

SECONDARY outcome

Timeframe: Pre-treatment to 6 weeks after treatment

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

Outcome measures

Outcome measures
Measure	Treatment With Platelet Rich Fibrin Matrix n=15 Participants Both nasolabial folds treated with platelet rich fibrin matrix
Difference in Wrinkle Assessment Score Between Pretreatment and 6 Weeks	1.08 units on a scale Standard Deviation .59

Adverse Events

Treatment With Platelet Rich Fibrin Matrix

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 P Sclafani, MD

NY Eye & Ear Infirmary

Phone: 212-979-4200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place