AgingNCT05734248
Fractional Laser Drug Delivery of a Local Anesthetic
A study testing Facial filler injection in people with Aging and Face; Atrophy, run by University Hospital, Ioannina at 2 sites in Greece.
Trial summary
The purpose of this study is to assess the clinical efficacy of fractional CO2 laser-assisted delivery of a topically applied anesthetic to the perceived pain during filler injection. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging, Face; Atrophy
- What is being tested?
- Facial filler injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 2 sitesGreece
- Study dates
- 6 Feb 2023to 5 Dec 2023
- 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
- Age ≥18 years
- Patient is willing and able to give written informed consent
- Patient asks for facial filler injections (hyaluronic acid) to improve the facial aesthetic/ aging signs
Who cannot join
- History of keloid or hypertrophic scar formation or complicated wound healing
- Presence of any active skin disease
- Known allergy to local anesthesia
- Pregnancy or lactation
- Incompetency to understand what the procedure involves
- Current complaints of chronic pain or other alterations in pain sensation (e.g. due to diabetes mellitus or lepra)
- Current treatment with systemic analgesics or other medication that can influence pain sensation
- Current treatment with anticoagulants
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Fractional Laser Drug Delivery of a Local Anesthetic to Mitigate Pain From Filler Injection
The purpose of this study is to assess the clinical efficacy of fractional CO2 laser-assisted delivery of a topically applied anesthetic to the perceived pain during filler injection.
Read the detailed description
Rationale: In daily practice, common aesthetic and laser procedures of the face are carried out under local anesthesia using topical formulations. This procedure is time-consuming, as the anesthetic has to be applied at least one hour before treatment, and is often only partially effective, especially on the face due to increased pain perception. The other option, of infiltration of an anesthetic solution, though effective, is often associated with discomfort, and is not favored during facial procedures (due to changes of the facial landmarks), while it is not tolerated by patients who have needle phobia. In the past years, enhanced and accelerated penetration of various topically applied substances, including photosensitizers, has been proven by pretreatment of the skin with a fractional laser, creating a pattern of microscopic ablation craters. There is also evidence that transdermal anesthetic cream absorption can be increased by fractional laser pretreatment. These outcomes might suggest that adequate local anesthesia may be achieved by applying an anesthetic drug topically on a skin surface pretreated with a fractional laser. However, little is known about the role and efficacy of the fractional laser on topical anesthetic delivery in the clinical setting of facial fillers injection.
Objective: The primary objective of this study is to assess the analgesic effect of fractional carbon dioxide laser-assisted delivery of a topical anesthetic cream (mixture of lidocaine and tetracaine) compared to the application of this anesthetic without fractional laser pretreatment.
Study design: Prospective, double-blinded, randomized, controlled, within subject, study.
Study population: 21 healthy volunteers ≥18 years, who give written informed consent Intervention: In each subject, each cheek region of the subject will be randomly allocated to (1) ablative fractional laser (AFL) pretreatment (5% density, 2.5 mJ/microbeam) followed by topical application of local anesthetic or (2) sham AFL followed by application of local anesthetic. Sham AFL will be done by delivering an AFL pass at the same 5% density and 2.5 mJ/microbeam right adjacent to the region of local anesthetic application on the cheek. After ten minutes incubation time, the typical filler injections procedure will be performed, through the same always entry points.
Subjects will be asked to indicate pain on a visual analogue scale (VAS) from 0-10 (0: no pain; 10: worst imaginable pain) directly after treatment completion.
- Conditions
- Aging, Face; Atrophy
- Being tested
- Facial filler injection
- Medical subject headings
- Facies, Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Facial filler injectionProcedure or surgery
Also called hyaluronic acid injection
Hyaluronic acid will be injected on the cheek, based on the aesthetic evaluation of the face.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | This test region (right or left cheek) will be pretreated with a fractional carbon dioxide laser (ablative fractional laser; AFL) with a 100 μm spot at 5% density and a pulse energy of 2.5 mJ/microbeam, single pulse at t0 in a operator- and subject- blinded fashion. A lidocaine and tetracaine mixture cream will be applied at each cheek at t1.Ten minutes after cream application (incubation time), the facial filler injections will be performed.
Interventions: AFL Device: AFL Drug: anesthetic mixture cream Receives: Procedure: Facial filler injection |
| Control | Placebo comparator | A pass with the same fractional carbon dioxide laser with a 100 μm spot at 5% density and a pulse energy of 2.5 mJ/microbeam, single pulse will be given at the area right adjacent to the test region on the other to the intervention cheek ("sham AFL") at t0 in a operator- and subject-blinded fashion.
A lidocaine and tetracaine mixture cream will be applied at each cheek at t1.Ten minutes after cream application (incubation time), the facial filler injections will be performed.
Interventions: sham AFL Device: sham AFL Drug: anesthetic mixture cream Receives: Procedure: Facial filler injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain-Anesthetic effect of AFL
Pain evaluation of the injected filler, with a VAS (0 to 10)
Measured: immediately after the intervention/procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start6 Feb 2023
- Primary completion10 Oct 2023
- Study completion5 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Split-face model
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ioannina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Konstantinos Seretis, University Hospital, Ioannina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05734248
- Sponsor's protocol ID
- 00000010
- Status last verified
- May 2024
- First submitted
- 6 Feb 2023
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fractional Laser Drug Delivery of a Local Anesthetic to Mitigate Pain From Filler Injection
- ClinicalTrials.gov ID
- NCT05734248
- Acronym / sponsor ID
- 00000010
- Conditions
- Aging, Face; Atrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University Hospital, IoanninaUniversity, hospital or other
- Study start
- 6 Feb 2023 (actual)
- Primary completion
- 10 Oct 2023 (actual)
- Study completion
- 5 Dec 2023 (actual)
- First posted
- 17 Feb 2023 (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.
The purpose of this study is to assess the clinical efficacy of fractional CO2 laser-assisted delivery of a topically applied anesthetic to the perceived pain during filler injection.
Detailed description
Rationale: In daily practice, common aesthetic and laser procedures of the face are carried out under local anesthesia using topical formulations. This procedure is time-consuming, as the anesthetic has to be applied at least one hour before treatment, and is often only partially effective, especially on the face due to increased pain perception. The other option, of infiltration of an anesthetic solution, though effective, is often associated with discomfort, and is not favored during facial procedures (due to changes of the facial landmarks), while it is not tolerated by patients who have needle phobia. In the past years, enhanced and accelerated penetration of various topically applied substances, including photosensitizers, has been proven by pretreatment of the skin with a fractional laser, creating a pattern of microscopic ablation craters. There is also evidence that transdermal anesthetic cream absorption can be increased by fractional laser pretreatment. These outcomes might suggest that adequate local anesthesia may be achieved by applying an anesthetic drug topically on a skin surface pretreated with a fractional laser. However, little is known about the role and efficacy of the fractional laser on topical anesthetic delivery in the clinical setting of facial fillers injection.
Objective: The primary objective of this study is to assess the analgesic effect of fractional carbon dioxide laser-assisted delivery of a topical anesthetic cream (mixture of lidocaine and tetracaine) compared to the application of this anesthetic without fractional laser pretreatment.
Study design: Prospective, double-blinded, randomized, controlled, within subject, study.
Study population: 21 healthy volunteers ≥18 years, who give written informed consent Intervention: In each subject, each cheek region of the subject will be randomly allocated to (1) ablative fractional laser (AFL) pretreatment (5% density, 2.5 mJ/microbeam) followed by topical application of local anesthetic or (2) sham AFL followed by application of local anesthetic. Sham AFL will be done by delivering an AFL pass at the same 5% density and 2.5 mJ/microbeam right adjacent to the region of local anesthetic application on the cheek. After ten minutes incubation time, the typical filler injections procedure will be performed, through the same always entry points.
Subjects will be asked to indicate pain on a visual analogue scale (VAS) from 0-10 (0: no pain; 10: worst imaginable pain) directly after treatment completion.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Split-face model
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Procedure: Facial filler injectionThis test region (right or left cheek) will be pretreated with a fractional carbon dioxide laser (ablative fractional laser; AFL) with a 100 μm spot at 5% density and a pulse energy of 2.5 mJ/microbeam, single pulse at t0 in a operator- and subject- blinded fashion. A lidocaine and tetracaine mixture cream will be applied at each cheek at t1.Ten minutes after cream application (incubation time), the facial filler injections will be performed. Interventions: AFL Device: AFL Drug: anesthetic mixture cream |
| Control | Placebo comparator | Procedure: Facial filler injectionA pass with the same fractional carbon dioxide laser with a 100 μm spot at 5% density and a pulse energy of 2.5 mJ/microbeam, single pulse will be given at the area right adjacent to the test region on the other to the intervention cheek ("sham AFL") at t0 in a operator- and subject-blinded fashion. A lidocaine and tetracaine mixture cream will be applied at each cheek at t1.Ten minutes after cream application (incubation time), the facial filler injections will be performed. Interventions: sham AFL Device: sham AFL Drug: anesthetic mixture cream |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years
- Patient is willing and able to give written informed consent
- Patient asks for facial filler injections (hyaluronic acid) to improve the facial aesthetic/ aging signs
Key exclusion criteria (8 listed)
- History of keloid or hypertrophic scar formation or complicated wound healing
- Presence of any active skin disease
- Known allergy to local anesthesia
- Pregnancy or lactation
- Incompetency to understand what the procedure involves
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 |
|---|---|---|
| Facial filler injectionAlso: hyaluronic acid injectionHyaluronic acid will be injected on the cheek, based on the aesthetic evaluation of the face. | Procedure or surgery | Control, Intervention group |
Primary outcome
Pain-Anesthetic effect of AFL
Time frame: immediately after the intervention/procedure
Pain evaluation of the injected filler, with a VAS (0 to 10)
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 8 May 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Facial filler injection in people with Aging and Face; Atrophy, run by University Hospital, Ioannina at 2 sites in Greece.
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 3 inclusion and 8 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 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece. 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. Some participants in this study may receive a placebo. 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?
Pain-Anesthetic effect of AFL (time frame: immediately after the intervention/procedure). 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 8 May 2024.