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

Phase 4

Completed

• Conditions: Acne Keloidalis Nuchae; Tattoo
• Interventions: Drug: 2,5% lidocaine / 2,5% prilocaine cream; Drug: 7% lidocaine / 7% tetracaine cream; Device: Q-switched nd Yag laser

• Registration Number: NCT02372786
• Lead Sponsor: Erasmus Medical Center

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.

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2015-02-12
• Study First Submitted QC: 2015-02-20
• Study First Posted: 2015-02-26
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-19
• Last Update Posted: 2016-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• 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: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Acne Keloidalis Nuchae	2,5% lidocaine / 2,5% prilocaine cream	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.
Acne Keloidalis Nuchae	7% lidocaine / 7% tetracaine cream	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.
Tattoo	2,5% lidocaine / 2,5% prilocaine cream	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.
Tattoo	7% lidocaine / 7% tetracaine cream	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.
Tattoo	Q-switched nd Yag laser	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.

Primary Outcome Measures

Name	Time	Method
Self-reported pain (10 point visual analog scale).	5 minutes

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Erasmus MC; 🇳🇱 Rotterdam, Zuid-Holland, Netherlands