7% Lidocaine/7% Tetracaine Cream Versus 2,5% Lidocaine / 2,5% Prilocaine Cream

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

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.

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.

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.