Pain during laser treatment of: 1. Tattoo 2. Acne keloidalis nuchae
Conditions
Interventions
Trade Name: Pliaglis
Product Name: lidocaïne/tetracaïne
Pharmaceutical Form: Cream
Trade Name: Emla
Product Name: lidocain/prilocain
Pharmaceutical Form: Cream
Sponsors
None listed
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Subject has provided informed consent; • Subject is = 18 years of age at time of screening; • Group A: subjects with Fitzpatrick skintype V or VI and acne keloidalis nuchae; • Group B: subjects with an uniform, black, professionally placed tattoo. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
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 |
|---|---|
| Main Objective: 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;Secondary Objective: - To evaluate the percentage of patients that report adequate pain relief for the two topical anaesthetic creams; - To monitor the nature and frequency of adverse events; - To evaluate the amount of money patients would be willing to pay for the treatment that provided superior pain reduction; ;Primary end point(s): Self-reported pain (10 point visual analog scale).;Timepoint(s) of evaluation of this end point: After one treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - adequate pain relief (yes/no); - amount of money willing to spend for best pain relief. ;Timepoint(s) of evaluation of this end point: After one treatment | — |
Countries
Netherlands
Outcome results
None listed