E05.642.500NCT04750421
Transillumination to Reduce Post-injection Complications in Aesthetic Medicine
A study testing Transillumination Venolux® in people with E05.642.500, run by Helynck, Patrick, M.D. at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- E05.642.500
- What is being tested?
- Transillumination Venolux®
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2018to 1 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients presenting for facial injections of hyaluronic acid
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transillumination: A Non Invasive Method to Reduce Complications Associated With Facial Injections 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.
Read the detailed 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.
- Conditions
- E05.642.500
- Being tested
- Transillumination Venolux®
- Keywords
- transillumination, Aesthetic injection, asthetic post-injection complications, hyaluronic acid, Facial injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transillumination Venolux®Device
Transillumination Venolux® method was used on the other half of the face before injections to visualize veins.
| Study group | Role | What they receive |
|---|---|---|
| Transillumination Venolux® | Experimental | Transillumination using Venolux was used to visualize veins in the hemiface before hyaluronic acid injections Receives: Device: Transillumination Venolux® |
| Comparator group | No intervention | No vascular exploration methods were used on the other hemiface |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of vessels detected by using transillumination
counting the number of vessels detected by using transillumination in relation to the number of existing vessels.
Measured: Before facial injections
Secondary outcomes (1)
Number of bruises and hematoma
Number of bruises and heamatoma post-injection in in the hemiface where Transillumination is used versus control hemiface
Measured: At day 3 after facial injections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study start1 Mar 2018
- Primary completion1 Jun 2018
- Study completion1 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for E05.642.500Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The random assignment of the right or left side of the face on which the trasnillumination will be used will be done by numbered and sealed envelope. Envelopes will be prepared before the start of inclusion. Each envelope will contain a sheet of paper whose contents cannot be guessed when the envelope is closed. Each sheet will be marked either "Left+TL" or "Right+TL". Each envelope will contain a unique code number that will be randomly assigned to each patient after inclusion.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helynck, Patrick, M.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Meningaud, MD.PhD, Principal investigator, Department of plastic and reconstructive surgery-Henri Mondor Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04750421
- Sponsor's protocol ID
- 2017-A03325-48
- Status last verified
- Feb 2021
- First submitted
- 8 Feb 2021
- Last updated
- 15 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transillumination: A Non Invasive Method to Reduce Complications Associated With Facial Injections in Aesthetic Medicine.
- ClinicalTrials.gov ID
- NCT04750421
- Acronym / sponsor ID
- 2017-A03325-48
- Conditions
- E05.642.500
- Keywords
- transillumination, Aesthetic injection, asthetic post-injection complications, hyaluronic acid, Facial injection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Helynck, Patrick, M.D.University, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 11 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The random assignment of the right or left side of the face on which the trasnillumination will be used will be done by numbered and sealed envelope. Envelopes will be prepared before the start of inclusion. Each envelope will contain a sheet of paper whose contents cannot be guessed when the envelope is closed. Each sheet will be marked either "Left+TL" or "Right+TL". Each envelope will contain a unique code number that will be randomly assigned to each patient after inclusion.
| Arm | Type | Receives |
|---|---|---|
| Transillumination Venolux® | Experimental | Device: Transillumination Venolux®Transillumination using Venolux was used to visualize veins in the hemiface before hyaluronic acid injections |
| Comparator group | No intervention | –No vascular exploration methods were used on the other hemiface |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients presenting for facial injections of hyaluronic acid
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transillumination Venolux®Transillumination Venolux® method was used on the other half of the face before injections to visualize veins. | Device | Transillumination Venolux® |
Primary outcome
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.
1 secondary outcome
Number of bruises and hematoma
Time frame: At day 3 after facial injections
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Meningaud, MD.PhD principal investigator
Department of plastic and reconstructive surgery-Henri Mondor Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transillumination Venolux® in people with E05.642.500, run by Helynck, Patrick, M.D. at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of vessels detected by using transillumination (time frame: Before facial injections). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2021.