Clinical trial NCT02372786: 7% Lidocaine/7% Tetracaine Cream Versus 2,5% Lidocaine / 2,5% Prilocaine Cream
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tattoo
Acne Keloidalis Nuchae
Keywords: 7% lidocaine / 7% tetracaine cream
2,5% lidocaine / 2,5% prilocaine cream
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2015-02-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Self-reported pain (10 point visual analog scale).
timeFrame: 5 minutes
Secondary outcomes:
measure: adequate pain relief (yes/no);
timeFrame: 10 minutes
measure: willing to spend around 25 euro for best pain relief (yes/no).
timeFrame: 10 minutes
measure: To monitor the nature and frequency of adverse events
timeFrame: one week
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus MC
state: Zuid-Holland
Study officials:
affiliation: Erasmus Medical Center
name: Martijn van Doorn, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: