Skip to main content
OpenTrials
Completed

NCT Number: NCT02372786

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Erasmus MC

Rotterdam, South Holland, 3015CA, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

2,5% lidocaine / 2,5% prilocaine cream

Drug

The treatment area will be divided in two equal parts with white markings. Between these two areas an area of 1 cm will be marked. This area will be left untreated, to avoid possible spill-over effects of the two anaesthetic creams. A thick layer of 2,5% lidocaine / 2,5% prilocaine cream will be applied on one side to the intact skin under plastic occlusion (average of 1,5-2g per 10 cm2) 60 minutes before laser treatment.

Other names: Emla®

7% lidocaine / 7% tetracaine cream

Drug

The treatment area will be divided in two equal parts with white markings. Between these two areas an area of 1 cm will be marked. This area will be left untreated, to avoid possible spill-over effects of the two anaesthetic creams. A thin layer of 7% lidocaine / 7% tetracaine cream (1mm) will be applied on the other side to the intact skin (average of 1,3g Pliaglis per 10 cm2) 60 minutes before laser treatment.

Other names: Pliaglis®

Neodymium-doped yttrium aluminium garnet (Nd:Yag) laser

Device

Acne keloidalis nuchae: during this study a 1064 nm Nd:yag laser with a spot size of 7-10 mm, and a fluence of 35-60J/cm2, (depending on the effective and safe clinical response), a pulse duration of 20-35 ms and 2 passes will be used.

Q-switched nd Yag laser

Device

Tattoo removal: we will use a 3 mm spotsize and a fluence depending on the absorption of the laser light, which is visible as skin whitening.

Primary outcomes

  1. Self-reported pain (10 point visual analog scale).

    Time frame: 5 minutes

Secondary outcomes

  1. adequate pain relief (yes/no);

    Time frame: 10 minutes

  2. willing to spend around 25 euro for best pain relief (yes/no).

    Time frame: 10 minutes

  3. To monitor the nature and frequency of adverse events

    Time frame: one week

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Registry information

Official study 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

Acronym: OPTICA

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 26, 2015
Registry last updated
Jan 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.