Frankel Ellen, Trumbore Mark W
J Clin Aesthet Dermatol. 2009 Apr;2(4):36-9.
This study evaluated a unique formulation of lidocaine 4% in an emollient aerosol foam microemulsion system to facilitate rapid delivery of the active ingredient and reduce pain associated with cosmetic dermatologic laser treatment.
This was a noncontrolled, open-label, paired, comparison study.
Private practice dermatology clinic.
Ten patients undergoing various cosmetic laser treatments, 18 years of age or older and considered clinically appropriate for study participation.
Primary endpoints were patient and clinician assessments of procedural pain intensity for the treated and untreated areas. Ratings were recorded on a visual analog scale ranging from "no pain at all" to "the most intense pain imaginable." Secondary study endpoints included clinician and patient subjective assessments of the lidocaine 4% foam.
Mean patient and clinician ratings of pain were significantly lower for areas treated with the lidocaine 4% foam compared with pain ratings for untreated areas. No adverse events were reported. Clinician's mean ratings for ease of application and overall satisfaction were favorable.
The results from this pilot, 10-patient, open-label study suggest that the lidocaine 4% foam may be acceptable to both patients and clinicians for the safe and effective reduction of pain associated with cosmetic dermatologic laser procedures. However, a blinded, placebo-controlled study of a larger population is needed to confirm these preliminary results.
本研究评估了一种独特配方的4%利多卡因，其制成润肤气雾剂泡沫微乳剂系统，以促进活性成分的快速递送，并减轻与美容皮肤科激光治疗相关的疼痛。
这是一项非对照、开放标签、配对比较研究。
私立皮肤科诊所。
10名接受各种美容激光治疗的患者，年龄在18岁及以上，临床认为适合参与研究。
主要终点是患者和临床医生对治疗区域和未治疗区域的手术疼痛强度的评估。评分记录在视觉模拟量表上，范围从“完全无痛”到“难以想象的最剧烈疼痛”。次要研究终点包括临床医生和患者对4%利多卡因泡沫的主观评估。
与未治疗区域的疼痛评分相比，使用4%利多卡因泡沫治疗的区域，患者和临床医生的平均疼痛评分显著更低。未报告不良事件。临床医生对应用便利性和总体满意度的平均评分良好。
这项针对10名患者的开放标签试点研究结果表明，4%利多卡因泡沫对于患者和临床医生而言，可能是安全有效地减轻与美容皮肤科激光手术相关疼痛的可接受方法。然而，需要对更大规模人群进行一项双盲、安慰剂对照研究来证实这些初步结果。
