Prospective, Randomized, Double-blinded, Split-face Study Comparing Efficacy of Lidocaine 2.5%/Prilocaine 2.5% Cream Under Occlusion, and Lidocaine 23% /Tetracaine 7% Ointment for Anesthesia Prior to 1927nm Fractional Laser Treatment
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Self-reported Pain After Laser Treatment
研究概览
简要总结
The purpose of this study is to determine the efficacy of lidocaine 2.5%/prilocaine 2.5% cream versus lidocaine 23%/tetracaine 7% ointment for topical anesthesia prior to a nonablative laser procedure.
详细描述
Lidocaine 23% / tetracaine 7% ointment and lidocaine 2.5%/ prilocaine 2.5% cream are both topical anesthetics that are used commonly to locally anesthetize the skin prior to laser procedures. With the increased use of powerful lasers for medical and cosmetic purposes, adequate pain control is necessary. This study will compare the efficacy of lidocaine 23% / tetracaine 7% ointment and lidocaine 2.5%/ prilocaine 2.5% cream in reducing self-reported pain after laser treatment. It will also aim to determine the amount of redness, burning and itching a patient experiences with each cream, and if any symptoms of lidocaine toxicity are experienced.
Prior to the procedure, we will randomly assign half of the face to be applied with 2.5 g of lidocaine 23% / tetracaine 7% ointment without occlusion and the other half of the face with 7.5 g lidocaine 2.5%/ prilocaine 2.5% cream with occlusion. After 60 minutes we will remove the creams with soap and water. Next, the patient will be treated with a fractional thulium fiber laser with a fluence of 20 millijoules and treatment level of 7-11. Standard post procedure instructions will be given, and surveys on symptoms and pain will be completed by both patient and investigator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female in general good health.18 years of age or older.
- •Undergoing 1927nm fractional thulium laser treatment.
- •Fitzpatrick skin type I-IV with at least mild photodamage of the face by physician discretion.
- •Subject has completed an appropriately administered informed consent process which includes signing the institutional review board (IRB) approved consent form.
- •Willingness to have facial exams and digital photos performed of the face.
- •Female patients will be either of non-childbearing potential defined as:
- •Having no uterus;
- •No menses for at least 12 months; or
- •(WOCBP) women of childbearing potential must agree to use an effective method of birth control during the course of the study, such as:
- •Oral contraceptive pill, injection, implant, patch, vaginal ring, intrauterine device;
- •Intrauterine coil;
- •Bilateral tubal ligation;
- •Barrier method used with an additional form of contraception (e.g., sponge, spermicide or condom);
- •Abstinence (if practicing abstinence must agree to use barrier method described above if becomes sexually active);
- •Vasectomized partner (Must agree to use barrier method described above if becomes sexually active with non-vasectomized).
排除标准
- •Presence of incompletely healed wound or active skin disease within in treatment area.
- •Pregnant, planning pregnancy or breastfeeding during the course of the study.
- •Individuals who have ablative laser within 6 months; non ablative lasers, facial peels, or dermabrasion within 1 month.
- •Individuals with known allergies or sensitivities to any of the ingredients of any topical products being used in this study (a list of the products with active and excipients will be provided below).
- •Subjects with any pre-existing medical or psychological condition which, in the opinion of the investigator, would put them at increased risk due to study treatment or participation.
- •Subjects who are unable to comprehend the study consent document or provide full written consent.
- •Subjects who have taken isotretinoin within 3 months or systemic corticosteroids within 1 month.
- •Subjects with history of severe cardiovascular disease, kidney disease, liver disease, uncontrolled diabetes, uncontrolled seizures, immunosuppression.
研究组 & 干预措施
2.5 g of lidocaine 23% / tetracaine 7% ointment
Patients undergoing 1927 nm fractional thulium fiber laser treatment of the face for photodamage as part of normal clinical care will have randomly assigned half of the face applied with 2.5 g of lidocaine 23% / tetracaine 7% ointment without occlusion for 60 minutes.
干预措施: 2.5 g of lidocaine 23% / tetracaine 7% ointment without occlusion (Drug)
7.5 g lidocaine 2.5%/ prilocaine 2.5% cream
Patients undergoing 1927 nm fractional thulium fiber laser treatment of the face for photodamage as part of normal clinical care will have randomly assigned half of the face applied with 7.5 g lidocaine 2.5%/ prilocaine 2.5% cream with occlusion for 60 minutes.
干预措施: 7.5 g lidocaine 2.5%/ prilocaine 2.5% cream with occlusion (Drug)
结局指标
主要结局
Self-reported Pain After Laser Treatment
时间窗: After laser treatment, approximately 60 minutes
Participants were asked to rate their pain using the self-reported visual analog scale (VAS). The VAS uses a scale of 0 = no pain to 10 = worst pain. Total scores range from 0 - 10, with lower scores indicating lower pain and higher scores indicating greater pain.
次要结局
- Number of Participants Who Self-reported Itching After Laser Treatment(After laser treatment, approximately 60 minutes)
- Number of Participants Who Self-reported Burning After Laser Treatment(After laser treatment, approximately 60 minutes)
研究者
Elika Hoss, MD
Principal Investigator
Mayo Clinic