Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05734248 |
| Other study ID # |
00000010 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 6, 2023 |
| Est. completion date |
December 5, 2023 |
Study information
| Verified date |
May 2024 |
| Source |
University Hospital, Ioannina |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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.
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.
