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.
Recruiting
- Conditions
- 2. acne keloidalis nuchaelaser treatment of: 1. tattoos10040798
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 30
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Self-reported pain (10 point visual analog scale).</p><br>
- Secondary Outcome Measures
Name Time Method <p>- adequate pain relief (yes/no);<br /><br>- willingness to spend 25 euro for the best pain relief.</p><br>