A Double Blind Randomized Controlled Trial Comparing the Efficacy of 7% Lidocaine / 7% Tetracaine Cream Versus 2,5% Lidocaine / 2,5% Prilocaine Cream for Local Anaesthesia During Laser Treatment of Acne Keloidalis Nuchae and Tattoo Removal
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Self-reported pain (10 point visual analog scale).
研究概览
简要总结
The purpose of this study is to compare the efficacy of 7% lidocaine / 7% tetracaine cream and 2,5% lidocaine / 2,5% prilocaine cream in reducing self-reported pain during a single laser procedure in the treatment of acne keloidalis nuchae and tattoo removal.
详细描述
In this study we will compare the efficacy of 7% lidocaine / 7% tetracaine cream and 2,5% lidocaine / 2,5% prilocaine cream in reducing self-reported pain during a single laser procedure in the treatment of acne keloidalis nuchae and tattoo removal. Patients will be asked to fill in questionnaires to:
- assess the severity of pain experienced (VAS score) during laser treatment,
- evaluate whether the pain relief is adequate and,
- evaluate the amount of money patients would be willing to pay for the cream that provided the 'best' pain relief.
One week after the visit the patient will have a telephone consultation. The patients will be asked if they experienced any symptoms, which will be recorded as adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 是
入选标准
- •• Subject has provided written informed consent;
- •Subject is ≥ 18 years of age at time of screening;
- •Group A: subjects with acne keloidalis nuchae;
- •Group B: subjects with an uniform, black, professionally placed tattoo
排除标准
- •• Known sensitivity to any components of the test materials;
- •Pregnant or breast-feeding women;
- •Use of any other pain medication during past 24 hours prior to the laser treatment;
- •Damaged skin at the designated treatment site;
- •Blister formation and/or scar formation after test-treatment with standard laser settings;
- •Any medical or psychiatric condition which, in the investigator's opinion, would preclude the participant from adhering to the protocol or completing the study per protocol.
研究组 & 干预措施
Acne Keloidalis Nuchae
2,5% lidocaine / 2,5% prilocaine cream and 7% lidocaine / 7% tetracaine cream will be applied for 60 minutes. After removal of the creams patients will recieve laser hair removal treatment using a neodymium-doped yttrium aluminium garnet (Nd:Yag) laser.
干预措施: 2,5% lidocaine / 2,5% prilocaine cream (Drug)
Acne Keloidalis Nuchae
2,5% lidocaine / 2,5% prilocaine cream and 7% lidocaine / 7% tetracaine cream will be applied for 60 minutes. After removal of the creams patients will recieve laser hair removal treatment using a neodymium-doped yttrium aluminium garnet (Nd:Yag) laser.
干预措施: 7% lidocaine / 7% tetracaine cream (Drug)
Tattoo
2,5% lidocaine / 2,5% prilocaine cream and 7% lidocaine / 7% tetracaine cream will be applied for 60 minutes. After removal of the creams patients will recieve laser tattoo removal treatment using a Q-switched nd Yag laser.
干预措施: 2,5% lidocaine / 2,5% prilocaine cream (Drug)
Tattoo
2,5% lidocaine / 2,5% prilocaine cream and 7% lidocaine / 7% tetracaine cream will be applied for 60 minutes. After removal of the creams patients will recieve laser tattoo removal treatment using a Q-switched nd Yag laser.
干预措施: 7% lidocaine / 7% tetracaine cream (Drug)
Tattoo
2,5% lidocaine / 2,5% prilocaine cream and 7% lidocaine / 7% tetracaine cream will be applied for 60 minutes. After removal of the creams patients will recieve laser tattoo removal treatment using a Q-switched nd Yag laser.
干预措施: Q-switched nd Yag laser (Device)
结局指标
主要结局
Self-reported pain (10 point visual analog scale).
时间窗: 5 minutes
次要结局
- willing to spend around 25 euro for best pain relief (yes/no).(10 minutes)
- adequate pain relief (yes/no);(10 minutes)
- To monitor the nature and frequency of adverse events(one week)
研究者
M.B.A. van Doorn
MD, PhD
Erasmus Medical Center