Transillumination to Reduce Post-injection Complications in Aesthetic Medicine

E05.642.500 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04750421
• Other study ID #: 2017-A03325-48
• Status: Completed
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: July 1, 2018

Study information

• Verified date: February 2021
• Source: Helynck, Patrick, M.D.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: July 1, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• E05.642.500

Intervention

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

Locations

Country	Name	City	State
France	MEZI	Créteil

Sponsors (1)

Lead Sponsor	Collaborator
Helynck, Patrick, M.D.

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of vessels detected by using transillumination	counting the number of vessels detected by using transillumination in relation to the number of existing vessels.	Before facial injections
Secondary	Number of bruises and hematoma	Number of bruises and heamatoma post-injection in in the hemiface where Transillumination is used versus control hemiface	At day 3 after facial injections