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

Erasmus Medical Center30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Tattoo Acne Keloidalis Nuchae

Interventions

2,5% lidocaine / 2,5% prilocaine creamDRUG

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.

7% lidocaine / 7% tetracaine creamDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Erasmus MC

Rotterdam, South Holland, Netherlands

Outcomes

Primary Outcomes

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

Time frame: 5 minutes

Secondary Outcomes

adequate pain relief (yes/no);

Time frame: 10 minutes

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

Time frame: 10 minutes

To monitor the nature and frequency of adverse events

Time frame: one week

Data from ClinicalTrials.gov

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