local anesthesia of the skin prior to laser therapy of acne and traumatic scars
Conditions
Interventions
Trade Name: Ultracain DS Forte
Pharmaceutical Form: Solution for injection
Trade Name: EMLA cream
Pharmaceutical Form: Cream
Sponsors
Academic Medical Center, Amsterdam
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with acne scars or traumatic scars scheduled for treatment with the fractional carbon dioxide laser Age =18 years Patient is willing and able to give written informed consent 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 18 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Known allergy to local anesthesia Pregnancy or lactation Incompetency to understand what the procedure involves Current complaints of chronic pain or other alterations in pain sensation (e.g. due to diabetes mellitus or lepra) Current treatment with systemic analgesics or other medication that can influence pain sensation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to assess the efficacy of skin anesthesia using fractional laser assisted delivery of articaine hydrochloride 40 mg/ml and epinephrine 10 µg/ml solution compared to standard anesthesia with topical eutectic mixture of lidocaine 25 mg/g and prilocaine 25 mg/g cream.;Secondary Objective: N/A;Primary end point(s): The main study parameter is pain, as scored on a VAS from 0-10 (0: no pain; 10: worst imaginable pain) directly after fractional laser treatment.;Timepoint(s) of evaluation of this end point: directly after fractional laser treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A | — |
Countries
Netherlands
Contacts
Public ContactSNIP
Academic Medical Center
Outcome results
None listed