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PRP Administration in the Nasojugal Folds

NCT03255681 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2019-01-04

No results posted yet for this study

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.

Conditions

  • Facial Injuries and Disorders

Interventions

PROCEDURE

PRP injections into nasojugal folds

A topical anesthetic consisting of 4% Lidocaine (Topicaine) will be placed in the treatment zone prior to injections for no less than 20 minutes per manufactures recommendations. 11ml of whole blood will be drawn from the patient via venous aspiration into the Eclipse collection tube. The blood then is centrifuged into three basic components: red blood cells, PRP and platelet-poor plasma. The PRP component is collected via manufactures recommendation, drawn into sterile syringes, and prepared for injection into the patient. 0.1cc of 10% CaCl2 per 1ml of PRP will be added and mixed into the PRP solution for injections on one side of the face. Injections will be completed using Softfil micro-cannulas inserted via a small puncture through the patients' skin to dissect into the subcutaneous plane

Sponsors & Collaborators

  • David Grant U.S. Air Force Medical Center

    lead FED

Principal Investigators

  • Ryan M Diepenbrock, DMD · David Grant Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-31
Primary Completion
2019-02-01
Completion
2019-02-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03255681 on ClinicalTrials.gov