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OpenTrials
Completed

NCT Number: NCT04750421

Transillumination to Reduce Post-injection Complications in Aesthetic Medicine

Transillumination (TL) is a noninvasive technique that appears to allow preliminary detection of superficial vascular structures of the face to avoid intravascular HA injection. The purpose of our study was to test the efficacy of TL in terms of its sensitivity to locate vessels in the areas undergoing treatment and to reduce post-injection vascular complications.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MEZI

Créteil, 94000, France

About this study

Transillumination was used during the injection of hyaluronic acid to reduce the risk of intravascular injection. For the purpose of randomization, patients were asked to choose a sealed envelope. Inside the envelope was a piece of paper indicating on which side of the face (right or left) the transillumination would be used.

For each filler injection, transillumination was used on one side; on the other side of the face, the injection was administered without the use of any vascular exploration method. After the vessels had been located on the side chosen for the transillumination technique, a skin-marker pencil was used to draw the vascular mapping of the upper part of the face, which in our opinion represented the area most at risk of complications, the middle and the lower parts of the face.

Then ice was applied on both sides of the face for 15 s before to proceed with the injections in order to cause vasoconstriction and to further decrease the risk of an intravascular injection.Transillumination sensitivity for locating the vessels of the face was assessed.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients presenting for facial injections of hyaluronic acid

Exclusion criteria

  • Patients with a history of allergy to a component of hyaluronic acid
  • Patients with arteritis (Horton)
  • Patients who have had previous facial surgery
  • pregnant or nursing patients

Treatment and study plan

Transillumination Venolux®

Device

Transillumination Venolux® method was used on the other half of the face before injections to visualize veins.

Primary outcomes

  1. Number of vessels detected by using transillumination

    Time frame: Before facial injections

    counting the number of vessels detected by using transillumination in relation to the number of existing vessels.

Secondary outcomes

  1. Number of bruises and hematoma

    Time frame: At day 3 after facial injections

    Number of bruises and heamatoma post-injection in in the hemiface where Transillumination is used versus control hemiface

Sponsors and collaborators

Lead sponsor

Helynck, Patrick, M.D.

Other

Registry information

Official study title

Transillumination: A Non Invasive Method to Reduce Complications Associated With Facial Injections in Aesthetic Medicine.

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 11, 2021
Registry last updated
Feb 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.