USAF Regulatory Concerns

The purpose of the study is to determine the efficacy of platelet-rich plasma (PRP) as a cosmetic facial injectable filler to treat tear troughs deformities secondary to volume loss and skin laxity in the infra-orbital region. Patients will receive injections of PRP on the left side, and PRP with A VectraH1 3D camera will be used to quantify the volume of the infra-orbital region before treatment, at 1, 3, 6 and 12 months post treatment. The objective is to quantify the amount of volume gained in the region as well as to assess duration of volumization after PRP treatment and also if volumization results are permanent.

The purpose of this study is to determine if PRP facial filler injections will provide effective long-term restoration of facial volume, specifically at the tear troughs. The study is a controlled trial. The attending surgeon and residents will perform the procedure. Pre-treatment photographs will be obtained of the patient using a VectraH1 3D head & neck camera. The provider will complete PRP injections first on the left side followed by PRP with calcium chloride on the right side. At no point during the study will we deviate from the standard of care for treatment with PRP or PRP with CaCl2. 0.1cc of 10% calcium chloride per 1mL of platelet rich plasma will be mixed. The volume of PRP and will be used upon the discretion of provider for treatment of the cosmetic facial deformity.

One of the most common filler materials used today are hyaluronic acid derivatives [13]. While these types of fillers offer certain advantages over bovine and collagen derived materials that may require skin testing prior to treatment; they can be expensive and will require ongoing injections as they absorb [14]. Autogenous fillers such as autogenous fat can offer a permanent solution, which may therefore decrease the net cost compared to hyaluronic acid derived fillers, but has higher morbidity associated with the fat harvesting and transfer [15-17]. PRP as a filler material may be the least expensive option with the lowest morbidity even if the effects are not yet proven to be permanent.

To evaluate whether the PRP facial filler treatment provides long term restoration of facial volume, patients will return for additional photographs and data collection using the VectraH1 3D head & neck camera at one, three, six and twelve months after treatment. The primary outcome will be the amount of facial volume achieved in the tear troughs, as assessed with the VectraH1 3D head & neck camera and VECTRA Capture Analysis module software to measure volume differences (cm3) pre- and post-treatment.

The Canfield VectraH1 3D head & neck camera is a high resolution device that captures the highest details and measures volume differences and contour changes of the face and neck. The camera allows for quantification of subsurface skin conditions using proprietary RBX® technology, allows for visualization of the degree of contour change with color distance mapping, allows for automated measurements to allow patients to understand their current conditions and visualize their post-treatment appearance. In contrast to previous 3D imaging systems, the VectraH1 is a low cost, highly portable system designed for facial imaging that has become very popular in cosmetic practice. It is a validated metric and is used within the cosmetic surgery community. The validation of tools used to measure surgical outcomes is fundamental for high-quality practice and outcomes research and studies performed with the VectraH1 show the system is accurate and comparable to other 3D imaging systems on the market such as 3dMDFace system. The advantage of the VectraH1 is the portability of the camera as opposed to a stationary system.

VectraH1 3D head & neck camera would be an asset for any training programs participating in cosmetic surgery and would be an asset to our study for several reasons. The 3D camera would allow us to most accurately assess the volume changes in the nasojugal folds using the color distance mapping technology to visualize the results rather than relying on sequential 2D imaging and clinical measurement, further reinforcing our study data and obtaining the most accurate results possible. Currently the VectraH1 3D head & neck camera is widely utilized in the cosmetic surgery community with testimonials from facial plastic surgeons warranting the ease of use of the product, the increase in patient satisfaction when using the camera as well as an exponential increase in use of facial fillers and fat transfer due to the realistic simulations the camera provides [18]. When patients can see the difference a filler procedure or fat transfer can provide prior to treatment, patient have a realistic expectation for what to expect and allow patients to see themselves as we do as cosmetic surgeons. This camera is a practice changer in that the clinician benefits with the most accurate imaging technology available for pre-treatment simulations and assessments as well as for the patient by offering the most realistic expectations for their individual treatment and opens the door for procedures they may not have previously considered. The use of this product would benefit our residency immensely in the cosmetic domain and keep us up-to-date with the technology that is available and utilized in private practice. This would also benefit the Air Force by opening the door for more potential candidates for cosmetic surgical procedures that may have foregone treatment once they can visualize the benefits of the procedures.

This study is projected to last approximately one year per patient. The tear trough facial volumes will be measured pre-procedure and at 1, 3, 6 and 12 months following the procedure. The data will be reviewed after an N of 50 is reached to assess the results. An interval evaluation of the data at N of 20 and 40 will be analyzed to evaluate for concerns regarding efficacy. The facial volumes reported will enable us to draw conclusions as to the overall success of the PRP facial filler injections with and without calcium chloride, and allow us to validate it's long term use as a viable facial filler.

At the conclusion of the study, the patient will have the option to treat the remaining tear trough with the PRP with calcium chloride facial filler treatment if results between the two sides are noticeable, unless if determined to be contraindicated by the attending physician.

Inclusion Criteria:

• Age ≥ 18
• Patients with deepened tear troughs who are scheduled to receive PRP injections in DGMC Oral & Maxillofacial Surgery clinic.

Exclusion Criteria:

• Pregnant or nursing
• History of any type of neuralgia or paresthesia, or paresis
• Allergy or contraindication to lidocaine
• Use of hyaluronic acid in last 12 months
• Use of facial filler in last 12 months
• Have an active inflammatory or infectious process at the injection site
• Documented bleeding dyscrasias to include thrombocytopenia or anemia, platelet or clotting factor disorders
• Severe coronary artery disease
• No history of facial trauma
• No midface deformity or herniation of fat pads
• Active use of aspirin or anticoagulants
• History of keloids or hypertrophic scarring

IPD will be available to other researches to include the efficacy of PRP and PRP with CaCl for use as a permanent facial filler if successful. Data shared will be sustainable volume measurements with PRP and PRP with CaCl.

At the completion of the study to be completed in Q1 or Q2 of 2018.

IPD Sharing Access Criteria not yet determined.

No masking.