An interventional study of Facial filler injection in Aging and Face; Atrophy, sponsored by University Hospital, Ioannina. Completed at 2 sites in Greece. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-08.
Sponsored by University Hospital, Ioannina · Not applicable, Interventional, and Other
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.
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.
125 studies on the registry are indexed under Atrophy; 21 are open to participants now.
This study's enrollment of 25 is below the median of 36 across 104 interventional studies indexed under Atrophy.
Browse Atrophy studies →University Hospital, Ioannina is the lead sponsor of 13 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Procedure: Facial filler injection
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
Procedure: Facial filler injection
Hyaluronic acid will be injected on the cheek, based on the aesthetic evaluation of the face.
Also known as: hyaluronic acid injection
Pain-Anesthetic effect of AFL
Pain evaluation of the injected filler, with a VAS (0 to 10)
Time frame: immediately after the intervention/procedure
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital, Ioannina