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
Overview
- Phase
- Phase 4
- Intervention
- 2,5% lidocaine / 2,5% prilocaine cream
- Conditions
- Tattoo
- Sponsor
- Erasmus Medical Center
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Self-reported pain (10 point visual analog scale).
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
M.B.A. van Doorn
MD, PhD
Erasmus Medical Center
Eligibility Criteria
Inclusion Criteria
- •• 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
Exclusion Criteria
- •• 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.
Arms & Interventions
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.
Intervention: 2,5% lidocaine / 2,5% prilocaine cream
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.
Intervention: 7% lidocaine / 7% tetracaine cream
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.
Intervention: 2,5% lidocaine / 2,5% prilocaine cream
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.
Intervention: 7% lidocaine / 7% tetracaine cream
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.
Intervention: Q-switched nd Yag laser
Outcomes
Primary Outcomes
Self-reported pain (10 point visual analog scale).
Time Frame: 5 minutes
Secondary Outcomes
- 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)