An Early Phase 1 interventional study of Hyaluronic Acid Filler and Platelet Rich Fibrin (PRF) and Hyaluronic Acid Filler and Saline in Tear Trough Hollowing, Under Eye Bags, sponsored by Rejuva Medical Aesthetics. Status unknown at 1 site in United States. Open to participants aged 20 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-18.
Sponsored by Rejuva Medical Aesthetics · Early Phase 1, Interventional, and Treatment
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.
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.
Exclusion Criteria:
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
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.
Also known as: Restylane-L
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.
Also known as: Restylane-L
Overall Tear Trough Rejuvenation
Restoration of volume loss and improved skin quality of the tear troughs
Time frame: 1 month
Improvement of Facial Rhytids
Reduction in wrinkles and appearance of "crepey" skin.
Time frame: 12 months
Plan to share: Undecided — 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.
No publications or documents are linked to this record.
This study is status unknown, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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Rejuva Medical Aesthetics