Acne Keloidalis Nuchae, Tattoo
Conditions
Keywords
7% lidocaine / 7% tetracaine cream, 2,5% lidocaine / 2,5% prilocaine cream
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.
Interventions
DRUG2,5% lidocaine / 2,5% prilocaine cream
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.
DRUG7% lidocaine / 7% tetracaine cream
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.
DEVICENeodymium-doped yttrium aluminium garnet (Nd:Yag) laser
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.
DEVICEQ-switched nd Yag laser
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.
Sponsors
Erasmus Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Self-reported pain (10 point visual analog scale). | 5 minutes |
Secondary
| Measure | 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 |
Countries
Netherlands
Outcome results
None listed