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Trial record 2 of 256867 for:    ALL

Platelet Rich Fibrin for Tear Trough Rejuvenation

This study is not yet open for participant recruitment.
Verified October 2017 by Alex Reivitis, Rejuva Medical Aesthetics
Sponsor:
ClinicalTrials.gov Identifier:
NCT03313934
First Posted: October 18, 2017
Last Update Posted: October 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Alex Reivitis, Rejuva Medical Aesthetics
  Purpose
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.

Condition Intervention Phase
Tear Trough Hollowing, Under Eye Bags Combination Product: Hyaluronic Acid Filler and Platelet Rich Fibrin (PRF) Combination Product: Hyaluronic Acid Filler and Saline Early Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
10 subjects will receive treatment with hyaluronic acid fillers for tear trough rejuvenation. Each subject with have one tear trough treated with HA filler mixed with Platelet Rich Fibrin, and the other tear trough injected with HA filler mixed with saline. The subject with be blind as to which tear trough contains the PRF. This will be randomly assigned for each subject and documented by the CRC.
Masking: Double (Participant, Outcomes Assessor)
Masking Description:
The subject will not be aware of which tear trough has the PRF condition. Additionally, the blind observer, who is going to evaluate improvement based on before/after photos, will also be blind to to which tear trough as treated with the PRF condition.
Primary Purpose: Treatment
Official Title: Platelet Rich Fibrin (PRF) With Hyaluronic Acid Fillers for Tear Trough Rejuvenation

Resource links provided by NLM:


Further study details as provided by Alex Reivitis, Rejuva Medical Aesthetics:

Primary Outcome Measures:
  • Overall Tear Trough Rejuvenation [ Time Frame: 1 month ]
    Restoration of volume loss and improved skin quality of the tear troughs

  • Improvement of Facial Rhytids [ Time Frame: 12 months ]
    Reduction in wrinkles and appearance of "crepey" skin.


Estimated Enrollment: 10
Anticipated Study Start Date: November 2017
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: November 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Restylane-L

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03313934


Contacts
Contact: Alex N Reivitis, BA 4246442400 alex@rejuvamedical.org
Contact: Sherry Leigh, BA 8187269917 sherry@rejuvamedical.org

Locations
United States, California
Rejuva Medical Aesthetics
Los Angeles, California, United States, 90025
Sponsors and Collaborators
Rejuva Medical Aesthetics
Investigators
Principal Investigator: Kian Karimi, MD,FACS Rejuva Medical Aesthetics
  More Information

Responsible Party: Alex Reivitis, Clinical Research Coordinator, Rejuva Medical Aesthetics
ClinicalTrials.gov Identifier: NCT03313934     History of Changes
Other Study ID Numbers: 20171835
First Submitted: October 13, 2017
First Posted: October 18, 2017
Last Update Posted: October 18, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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.

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

Keywords provided by Alex Reivitis, Rejuva Medical Aesthetics:
Hyaluronic Acid Filler
Platelet Rich Fibrin (PRF)
Tear Trough Filler

Additional relevant MeSH terms:
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents