Facial Injuries and Disorders Clinical Trial
— PRPOfficial title:
Efficacy of Platelet-Rich Plasma Filler for Treatment of Tear Trough Deformities
Verified date | January 2019 |
Source | David Grant U.S. Air Force Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | February 1, 2019 |
Est. primary completion date | February 1, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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David Grant U.S. Air Force Medical Center |
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* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
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Primary | Facial volume changes | The study control will be the facial volumes recorded for each patient on both sides of the face prior to injections of PRP and PRP with CaCl2. These values will be obtained through analysis using the VectraH1 3D head & neck camera and recorded pre-operatively. | 1, 3, 6 and 12 months |