local anesthesia of the skin prior to minor cutaneous surgical procedures
Conditions
Interventions
Trade Name: Ultracain DS Forte
Pharmaceutical Form: Solution for injection
Trade Name: Pliaglis cream
Pharmaceutical Form: Cream
Sponsors
Academic Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Fitzpatrick skin type I or II Age =18 years Subject 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 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: History of keloid or hypertrophic scar formation or complicated wound healing Presence of any active skin disease 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 leprosy) Current treatment with systemic analgesics or other medication that can influence pain sensation Current treatment with anticoagulants Fitzpatrick skin type III-VI Excessive sun tan
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives of the present study are to compare the effect of pretreatment with two different fractional laser modalities (CO2 and Er:YAG laser) on topical anesthesia and to compare the anesthetic effect of two different topical anesthetics on fractional laser pretreated skin.;Secondary Objective: Secondary objectives are to assess the role of the laser settings and occlusion time.;Primary end point(s): The main study endpoint is pain, as scored on a VAS from 0-10 (0: no pain; 10: worst imaginable pain) directly after a pain stimulus on test regions pretreated with either the fractional CO2 or the Er:YAG laser. The main study endpoint is pain, as scored on a VAS from 0-10 (0: no pain; 10: worst imaginable pain) directly after a pain stimulus on fractional laser pretreated test regions anesthetized with either AHES or LTC. ;Timepoint(s) of evaluation of this end point: Directly after each pain stimulus during treatment visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Pain, as scored on a VAS from 0-10 (0: no pain; 10: worst imaginable pain) directly after a pain stimulus on test regions pretreated with either 5% or 15% density. Pain, as scored on a VAS from 0-10 (0: no pain; 10: worst imaginable pain) directly after a pain stimulus on the test regions after 5, 15 or 25 minutes occlusion time of the anesthetic. Pain, as scored on a VAS from 0-10 (0: no pain; 10: worst imaginable pain) directly after pretreatment with each different laser type or setting. ;Timepoint(s) of evaluation of this end point: Directly after pretreatment with each different laser type or setting or after pain stimulus during the treatment session. | — |
Countries
Netherlands
Contacts
Public ContactSNIP
Academic Medical Center
Outcome results
None listed