Parameters in fractional laser assisted delivery of topical anesthetics: role of laser type, laser settings, type of anesthetic and occlusion time

Completed

Conditions: Not applicable
10014982

Registration Number: NL-OMON42648

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

Fitzpatrick skin type I or II
Age *18 years
Subject is willing and able to give written informed consent

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study endpoint in group A is pain, as scored on a VAS from 0-10 (0: no<br /><br>pain; 10: worst imaginable pain) directly after a pain stimulus on test regions<br /><br>pretreated with either the fractional CO2 or the Er:YAG laser.<br /><br><br /><br>The main study endpoint in group B is pain, as scored on a VAS from 0-10 (0: no<br /><br>pain; 10: worst imaginable pain) directly after a pain stimulus on fractional<br /><br>laser pretreated test regions anesthetized with either AHES or LTC.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Group A: Pain, as scored on a VAS from 0-10 (0: no pain; 10: worst imaginable<br /><br>pain) directly after a pain stimulus on test regions pretreated with either 5%<br /><br>or 15% density.<br /><br><br /><br>Group B: Pain, as scored on a VAS from 0-10 (0: no pain; 10: worst imaginable<br /><br>pain) directly after a pain stimulus on the test regions after 5, 15 or 25<br /><br>minutes occlusion time of the anesthetic.<br /><br><br /><br>Group A and B: Pain, as scored on a VAS from 0-10 (0: no pain; 10: worst<br /><br>imaginable pain) directly after pretreatment with each different laser type or<br /><br>setting.</p><br>