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

• Sponsor: The New York Eye & Ear Infirmary (Other)
• Overall Status: Completed
• CT.gov ID: NCT00874094
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arm: 1
• Duration (Months): 15
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

Platelets are a component of blood, which contain factors which can enhance wound healing. This study proposes to evaluate the clinical response of laugh lines treated with a concentrated preparation of the subject's own platelets injected into or under the skin by taking serial photographs of the subject's face over a 12 week period. Also, the same preparation will be injected into or under the skin of the arm near the elbows, and serial biopsies will be taken over a 12 week period.

Condition or Disease	Intervention/Treatment	Phase
Nasolabial Folds	Biological: Platelet rich fibrin matrix	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pilot Evaluation of Platelet Rich Fibrin Matrix (PRFM) for the Correction of Nasolabial Folds
• Study Start Date: Apr 1, 2008
• Actual Primary Completion Date: Jun 1, 2009
• Actual Study Completion Date: Jul 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: platelet rich fibrin matrix Both nasolabial folds treated with 0-2 cc of autologous platelet rich fibrin matrix,sufficient to efface nasolabial fold	Biological: Platelet rich fibrin matrix; 0-2 cc of autologous platelet rich fibrin matrix injected intra and subdermally to effect nasolabial fold.

Outcome Measures

Primary Outcome Measures

1. Difference in Wrinkle Assessment Score, Between Pre-treatment and 12 Weeks Post-treatment. [Difference in Measurements taken Pre-treatment and 12 weeks after treatment.]

   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.

Secondary Outcome Measures

1. Difference in Wrinkle Assessment Scores Between Pre-treatment and 1 Week [pre-treatment to 1 week 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 1 week

2. Difference in Wrinkle Assessment Score Between Pretreatment and 2 Weeks [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

3. Difference in Wrinkle Assessment Score Between Pretreatment and 6 Weeks [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 75 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• healthy adults

• aged 25- 75 years

• with moderate to severe nasolabial folds

Exclusion Criteria:

• pregnant

• allergy to local anesthetics

• history of bleeding disorder

• active infection at the treatment site

• injectable filler in the nasolabial folds within past year

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The New York Eye & Ear Infirmary- Otolaryngology Faculty practice satellite	Chappaqua	New York	United States	10514

Sponsors and Collaborators

• The New York Eye & Ear Infirmary

Investigators

• Principal Investigator: Anthony P Sclafani, MD, The New York Eye & Ear Infirmary

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The New York Eye & Ear Infirmary
• ClinicalTrials.gov Identifier: NCT00874094
• Other Study ID Numbers: 08.01
• First Posted: Apr 2, 2009
• Last Update Posted: Jul 12, 2013
• Last Verified: Jul 1, 2013

• Keywords provided by The New York Eye & Ear Infirmary: nasolabial folds; platelet rich plasma; fibrin matrix; facial rhytids; dermal filler

Study Results

Participant Flow

Recruitment Details	Patients with moderate to severe nasolabial folds were included.
Pre-assignment Detail	Any patient who refused to attend all scheduled follow up visits were to be excluded.

Arm/Group Title	Treatment With Platelet Rich Fibrin Matrix
Arm/Group Description	Both nasolabial folds treated with platelet rich fibrin matrix
Period Title: Overall Study
STARTED	15
COMPLETED	15
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Treatment With Platelet Rich Fibrin Matrix
Arm/Group Description	Both nasolabial folds treated with platelet rich fibrin matrix
Overall Participants	15
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	14 93.3%
>=65 years	1 6.7%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	54.27 (12.11)
Sex: Female, Male (Count of Participants)
Female	13 86.7%
Male	2 13.3%
Region of Enrollment (participants) [Number]
United States	15 100%

Outcome Measures

1. Primary Outcome

Title	Difference in Wrinkle Assessment Score, Between Pre-treatment and 12 Weeks Post-treatment.
Description	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.
Time Frame	Difference in Measurements taken Pre-treatment and 12 weeks after treatment.

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Treatment With Platelet Rich Fibrin Matrix
Arm/Group Description	Both nasolabial folds treated with platelet rich fibrin matrix
Measure Participants	15
Mean (Standard Deviation) [units on a scale]	1.13 (0.76)

2. Secondary Outcome

Title	Difference in Wrinkle Assessment Scores Between Pre-treatment and 1 Week
Description	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
Time Frame	pre-treatment to 1 week after treatment

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Treatment With Platelet Rich Fibrin Matrix
Arm/Group Description	Both nasolabial folds treated with platelet rich fibrin matrix
Measure Participants	15
Mean (Standard Deviation) [units on a scale]	.65 (.68)

3. Secondary Outcome

Title	Difference in Wrinkle Assessment Score Between Pretreatment and 2 Weeks
Description	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
Time Frame	Pre-treatment to 2 weeks after treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment With Platelet Rich Fibrin Matrix
Arm/Group Description	Both nasolabial folds treated with platelet rich fibrin matrix
Measure Participants	15
Mean (Standard Deviation) [units on a scale]	.97 (.75)

4. Secondary Outcome

Title	Difference in Wrinkle Assessment Score Between Pretreatment and 6 Weeks
Description	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
Time Frame	Pre-treatment to 6 weeks after treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment With Platelet Rich Fibrin Matrix
Arm/Group Description	Both nasolabial folds treated with platelet rich fibrin matrix
Measure Participants	15
Mean (Standard Deviation) [units on a scale]	1.08 (.59)

Adverse Events

Arm/Group Title	Treatment With Platelet Rich Fibrin Matrix
Arm/Group Description	Both nasolabial folds treated with platelet rich fibrin matrix
All Cause Mortality
	Treatment With Platelet Rich Fibrin Matrix
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Treatment With Platelet Rich Fibrin Matrix
	Affected / at Risk (%)	# Events
Total	0/15 (0%)
Other (Not Including Serious) Adverse Events
	Treatment With Platelet Rich Fibrin Matrix
	Affected / at Risk (%)	# Events
Total	0/15 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.