The Effect of Platelet-rich Fibrin Matrix on Skin Rejuvenation

The Effect of Platelet-rich Fibrin Matrix on Skin Rejuvenation: A Split Face Comparison

Platelet-rich fibrin matrix (PRFM) is made from platelets that are extracted from a patient's blood, and many plastic surgeons and dermatologists have used it to fill in wrinkles and lines on the face. Both patients and doctors have observed that it gives extra volume in these areas and improves overall appearance. However, there is no research that shows how PRFM affects skin quality, such as pores, spots, red areas, and texture. The aim of this study is to determine whether PRFM has a role in rejuvenating facial skin.

Study Overview

• Status: Completed
• Conditions: Wrinkle; Nasolabial Fold; Skin Rejuvenation; Skin Quality
• Intervention / Treatment: Procedure: PRFM injection; Procedure: Saline injection

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Valhalla, New York, United States, 10595
      • New York Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adults 18 years of age and older who had a dermatological concern, specifically, conspicuous spots, pores, rhytids, uneven texture, or red or brown discoloration, and a VISIA complexion analysis score greater than 10
• Agreed to continue any contraceptive hormonal therapy for duration of the study
• Agreed to not initiate the use of hormonal therapy during the study
• Agreed to not undergo any facial procedures or treatments, including injections and fillers, lasers, peels, and topical therapies, during the duration of the study
• Agreed to adhere to a standardized skin care regimen throughout the duration of the study consisting of the use of a single cleanser and moisturizer twice a day
• Agreed to refrain from excessive sun exposure/tanning

Exclusion Criteria:

• History of skin/connective tissue disorders
• History of immunosuppressive therapy or radiotherapy
• Participation in facial procedures, such as injections, lasers, peels, and dermabrasion, in the last six months
• Use of topical/prescription acne medications in the last three months
• Current smokers or prior smokers who quit fewer than 10 years ago

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PRFM; Hemi-face injected with PRFM. PRFM was produced from 9 mL of blood (Healeon Medical, Inc).	Procedure: PRFM injection; Using a 27-gauge microcannula, a total of 4 mL of PRFM was injected intradermally into the mid-cheek and NLF (2 mL for each site) on one side of the face.
Placebo Comparator: Saline; Hemi-face injected with saline.	Procedure: Saline injection; Using a 27-gauge microcannula, a total of 4 mL of saline was injected intradermally into the mid-cheek and NLF (2 mL for each site) on the contralateral side of the face.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in VISIA skin score	Difference between pre- and post-treatment VISIA analysis scores for skin parameters of spots, wrinkles, texture, and pores	Skin analysis performed at initial visit, at 6 weeks, and at 12 weeks following initial treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Wrinkle Severity Rating Scale	Difference between pre- and post-treatment quantitative grading of nasolabial folds for each group. Graded from 1 through 5, with 5 representing the worst score	Rating occurred at initial visit, at 6 weeks, and at 12 weeks following initial treatment
Skin Rejuvenation Outcomes Evaluation (SROE)	Patient-reported outcome measure validated for skin resurfacing techniques. Each item is rated on a 0-4 scale. The final score is computed by dividing the total score for the instrument by 24 and multiplying by 100, giving a range of 0-100. The difference in the change in SROE score for each cohort was calculated.	Evaluation distributed at initial visit, at 6 weeks, and at 12 weeks following treatment.
VISIA Outcomes Questionnaire	Evaluation targeted specifically at identifying changes in the skin parameters analyzed by VISIA. Each item is rated on a 0-4 scale. The final score is computed by dividing the total score for the instrument by 24 and multiplying by 100, giving a range of 0-100. The difference in the change in VISIA outcomes score for each cohort was calculated.	Evaluation distributed at initial visit, at 6 weeks, and at 12 weeks following treatment.

Collaborators and Investigators

• Sponsor: New York Medical College

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2018
• Primary Completion (Actual): May 28, 2019
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: October 13, 2019
• First Submitted That Met QC Criteria: October 13, 2019
• First Posted (Actual): October 16, 2019

Study Record Updates

• Last Update Posted (Actual): October 22, 2019
• Last Update Submitted That Met QC Criteria: October 19, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 12698

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No