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临床试验/NCT05734248
NCT05734248已完成不适用

Fractional Laser Drug Delivery of a Local Anesthetic to Mitigate Pain From Filler Injection

University Hospital, Ioannina2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2023年2月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
25
试验地点
2
主要终点
Pain-Anesthetic effect of AFL

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Other
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

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

干预措施: Facial filler injection (Procedure)

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

干预措施: Facial filler injection (Procedure)

结局指标

主要结局

Pain-Anesthetic effect of AFL

时间窗: immediately after the intervention/procedure

Pain evaluation of the injected filler, with a VAS (0 to 10)

次要结局

未报告次要终点

研究者

发起方
University Hospital, Ioannina
申办方类型
Other
责任方
Principal Investigator
主要研究者

Konstantinos Seretis

Ass. Professor of Plastic Surgery

University Hospital, Ioannina

研究点 (2)

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