Fractional laser assisted delivery of anesthetics

• Conditions: local anesthesia of the skin prior to minor cutaneous surgical procedures; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2014-001816-20-NL
• Lead Sponsor: Academic Medical Center, Amsterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08-19
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Fitzpatrick skin type I or II
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 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 lepra)
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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: The secondary objective is to compare the efficacy of these two different anesthetics, when applied according to the fractional laser drug delivery principle.;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 each pain stimulus.;Timepoint(s) of evaluation of this end point: Directly after the pain stimulus. Ten minutes after fractional laser pretreatment.;Main Objective: The primary objective of this study is to assess the analgesic effect of fractional carbon dioxide laser assisted delivery of two topical anesthetics (articaine hydrochloride 40 mg/ml and epinephrine 10 µg/ml solution and eutectic mixture of lidocaine 25 mg/g and prilocaine 25 mg/g cream) compared to application of these anesthetics without fractional laser pretreatment.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A