WithdrawnNot Applicable

PRP Administration in the Nasojugal Folds

Stopped: USAF Regulatory Concerns

0Started 2019-01-31

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Facial volume changes

Timeframe: 1, 3, 6 and 12 months

Trial details

NCT IDNCT03255681

SponsorDavid Grant U.S. Air Force Medical Center

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2019-02-01