Platelet Rich Fibrin for Tear Trough Rejuvenation

Platelet Rich Fibrin (PRF) With Hyaluronic Acid Fillers for Tear Trough Rejuvenation

The purpose of this study is to investigate the efficacy and longevity of Platelet Rich Fibrin (PRF) in combination with hyaluronic acid filler for cosmetic volume restoration of the tear troughs. This study will also evaluate visible improvement in skin texture that may be attributable to the added PRF.

Study Overview

• Status: Unknown
• Conditions: Tear Trough Hollowing, Under Eye Bags
• Intervention / Treatment: Combination product: Hyaluronic Acid Filler and Saline; Combination product: Hyaluronic Acid Filler and Platelet Rich Fibrin (PRF)

Detailed Description

Background: Platelet therapy is quickly becoming an integral aspect of cosmetic treatments. Most notably, Platelet Rich Plasma (PRP) has been used topically or as an injection to stimulate collagen production and enhance the efficacy of cosmetic procedures such as fat transfer, hair loss, laser treatments, and microneedling. Harvested PRP has platelets, fibrin, and white blood cells, which contribute to wound healing, neocollagenesis, and elastogenesis. Platelet Rich Fibrin (PRF) is the next generation of PRP and contains very high concentrations white blood cells, fibrin and a small amount of mesenchymal stem cells found circulating in our bloodstreams. Due to a lack of anticoagulant in the tube, PRF becomes a gel after 15-20 minutes of being isolated. This is useful in reconstructive and aesthetic medicine, which allows it to be used for cosmetic volume restoration in addition to topical indications.

Hyaluronic acid fillers have become increasingly popular in aesthetic medicine over the past two decades. Hyaluronic acid fillers are synthesized in a variety of different ways and last anywhere from 6 to 24 months, depending on the volume and location of the face or body they are injected. Fillers under the eyes in the "tear trough" area are popular treatments to allow patients to appear more refreshed and rested. Although this is an "off label" application of injectable fillers, it is extremely popular and is performed safely in many aesthetic clinics worldwide. Given that PRF can be used to restore volume, it will be determined if PRF in combination with hyaluronic acid filler will enhance resultant volume and skin quality in the treated areas.

Objective: The purpose of this study is to investigate the efficacy and longevity of Platelet Rich Fibrin (PRF) in combination with hyaluronic acid filler for cosmetic volume restoration of the tear troughs. This study will also evaluate visible improvement in skin texture that may be attributable to the added PRF.

Hypothesis: The addition of Platelet Rich Fibrin (PRF) to hyaluronic acid fillers contribute to volume restoration of the tear trough and also improve the texture and quality of the skin in the treated area. The patient will perceive a more natural and improved result on the PRF-treated side.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90025
      • Rejuva Medical Aesthetics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Males/females aged 20-80 who are experiencing moderate volume loss of the tear troughs and/or under eye bags. Eligible subjects will be in generally good health and able to provide a blood sample for treatment.

Exclusion Criteria:

• Those who fall outside of the age range 20-80 years of age, with chronic health problems including but not limited to thyroid disorders, cancer, blood disease, etc. Those who do not demonstrate volume loss of the tear troughs to the degree that warrants intervention. Conversely, those who are better suited for surgical intervention as opposed to non-surgical injections will not be eligible.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Hyaluronic Acid Filler with Saline; For each subject, one tear trough will be injected with hyaluronic acid filler mixed with saline. This arm will act as a control to evaluate the efficacy of PRF with hyaluronic acid.	Combination product: Hyaluronic Acid Filler and Saline; This intervention will use saline as a control to compare with PRF when mixed with hyaluronic acid fillers. Saline will dilute the HA filler in the same way PRF will, however saline as no growth factors or properties that will enhance treatment.; Other Names: Restylane-L
Experimental: Hyaluronic Acid Filler with Platelet Rich Fibrin (PRF); For each subject, one tear trough will be injected with hyaluronic acid filler mixed with Platelet Rich Fibrin (PRF). This study seeks to determine the efficacy of PRF in volumization of the tear trough and improvement of skin quality. This is the experimental condition.	Combination product: Hyaluronic Acid Filler and Platelet Rich Fibrin (PRF); The use of Restylane-L to volumize the tear trough has been well documented. Combining Restylane-L with Platelet Rich Fibrin (PRF) will be studied to evaluate if PRF enhances the volumization and skin quality of the treated areas.; Other Names: Restylane-L

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Tear Trough Rejuvenation	Restoration of volume loss and improved skin quality of the tear troughs	1 month
Improvement of Facial Rhytids	Reduction in wrinkles and appearance of "crepey" skin.	12 months

Collaborators and Investigators

• Sponsor: Rejuva Medical Aesthetics
• Investigators: Principal Investigator: Kian Karimi, MD,FACS, Rejuva Medical Aesthetics

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2017
• Primary Completion (Anticipated): November 1, 2018
• Study Completion (Anticipated): November 1, 2018

Study Registration Dates

• First Submitted: October 13, 2017
• First Submitted That Met QC Criteria: October 17, 2017
• First Posted (Actual): October 18, 2017

Study Record Updates

• Last Update Posted (Actual): October 18, 2017
• Last Update Submitted That Met QC Criteria: October 17, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Hyaluronic Acid Filler; Platelet Rich Fibrin (PRF); Tear Trough Filler
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: 20171835

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: The data will be collected, organized, and summarized in a manuscript to be submitted for publication. The publication will be available for other researchers to review.

Drug and device information, study documents

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