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

Study Overview
=================
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.

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

Conditions
-----------------
Tattoo, Acne Keloidalis Nuchae

Intervention / Treatment
-----------------
* Drug: 2,5% lidocaine / 2,5% prilocaine cream
* Drug: 7% lidocaine / 7% tetracaine cream
* Device: Neodymium-doped yttrium aluminium garnet (Nd:Yag) laser
* Device: Q-switched nd Yag laser


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Acne Keloidalis Nuchae<br>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. | Drug: 2,5% lidocaine / 2,5% prilocaine cream<br>* 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.<br>* Other names: Emla®;Drug: 7% lidocaine / 7% tetracaine cream<br>* 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.<br>* Other names: Pliaglis®;Device: Neodymium-doped yttrium aluminium garnet (Nd:Yag) laser<br>* 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.<br>|
| Other: Tattoo<br>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. | Drug: 2,5% lidocaine / 2,5% prilocaine cream<br>* 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.<br>* Other names: Emla®;Drug: 7% lidocaine / 7% tetracaine cream<br>* 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.<br>* Other names: Pliaglis®;Device: Q-switched nd Yag laser<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported pain (10 point visual analog scale). |  | 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adequate pain relief (yes/no); |  | 10 minutes | 
| willing to spend around 25 euro for best pain relief (yes/no). |  | 10 minutes | 
| To monitor the nature and frequency of adverse events |  | one week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
7% lidocaine / 7% tetracaine cream, 2,5% lidocaine / 2,5% prilocaine cream