Local Anesthesia of the Skin Clinical Trial
Official title:
Parameters in Fractional Laser Assisted Delivery of Topical Anesthetics: Role of Anesthetic and Application Time
The purpose of this study are to compare the efficacy of two different commercially available local anesthetics on AFXL pretreated skin and to assess the role of the application time in this technique.
Rationale: In dermatology anesthetics are frequently injected or topically applied to achieve
local anesthesia. Injectable anesthetics are effective but uncomfortable during
administration, especially for people who are needle phobic. Application of topical
anesthesia is painless but time consuming and often only partial aesthesia is achieved due to
the barrier function of the stratum corneum. (Manuskiatti, Triwongwaranat et al. 2010)
Penetration of local anesthetics could be enhanced by pretreatment of the skin with ablative
fractional lasers (AFXL) which locally disrupts the stratum corneum by creating an array of
microscopic ablation channels. (Sklar, Burnett et al. 2014) In a previous pilot study,
conducted at our institute, we demonstrated that effective anesthesia could be achieved
within ten minutes after application of a topical anesthetic on skin pretreated with AFXL at
painless settings. (Meesters, Bakker et al. 2015) However, little is still known about the
role of the type of anesthetic the type of anesthetic and the application time on the
efficacy of the anesthesia.
Objective: The objective of this study is to compare the efficacy of two different
commercially available local anesthetics on AFXL pretreated skin, a low concentration
articaine solution and a high concentration lidocaine/tetracaine cream. We also aim to
compare the efficacy of AFXL assisted topical anesthesia after various different application
times.
Study design: Prospective, single blinded, randomized, controlled, within subject, pilot
study.
Study population: 15 healthy volunteers ≥18 years, who give written informed consent
Intervention: In each subject, six test regions on subject's back of 1x1 cm will be
pretreated with the fractional carbon dioxide (CO2) laser at 2.5 mJ and 15% density and will
be randomly allocated to application of (I) articaine hydrochloride 40 mg/ml + epinephrine 10
μg/ml 30 solution (AHES) (5 minutes application time), (II) AHES (15 minutes application
time), (III) AHES (25 minutes application time), (IV) lidocaine 70 mg/g + tetracaine 70 mg/g
cream (LTC) (5 minutes application time, (V) LTC (15 minutes application time), (VI) LTC (25
minutes application time). After 15 minutes a pain stimulus, consisting of a pass with the
fractional CO2 laser at 50 mJ and 5% density (scanned area 6x6 mm), will be given at each
test region. In addition, a reference pain stimulus with the CO2 laser at the same settings
will be given at unanesthetized skin. 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 each
pain stimulus
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02938286 -
Fractional Laser Assisted Delivery of Anesthetics III
|
Phase 4 |