Local Anesthesia of the Skin Clinical Trial
Official title:
Parameters in Fractional Laser Assisted Delivery of Topical Anesthetics: Role of Laser Type and Laser Settings
The purpose of this study is to compare the effect of pretreatment with two different ablative laser modalities, a CO2 laser and an Er:YAG laser, and to assess the role of laser density in fractional laser assisted topical anesthesia.
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 fractional laser used (e.g. CO2 or Er:YAG laser), the laser settings,
the type of anesthetic and the occlusion time on the efficacy of the anesthesia.
Objective: The objectives of this study are to compare the efficacy of pretreatment with two
different ablative laser modalities, a CO2 laser and an Er:YAG laser, and to assess the role
of laser density in fractional laser assisted topical anesthesia.
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, four test regions on subject's back of 1x1 cm will be
randomly allocated to (I) pretreatment with the fractional CO2 laser at 5% density, (II)
pretreatment with the fractional CO2 laser at 15% density, (III) pretreatment with the
fractional Er:YAG laser at 5% density and (IV) pretreatment with the fractional Er:YAG laser
at 15% density. After pretreatment, articaine hydrochloride 40 mg/ml + epinephrine 10 μg/ml
30 solution (AHES) will be applied on the test regions with 15 minutes occlusion 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 |
NCT03279757 -
Fractional Laser Assisted Delivery of Anesthetics IIIb
|
Phase 4 |