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Fractional laser assisted skin anesthesia

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
EUCTR2015-002289-21-NL
Lead Sponsor
Academic Medical Center
Brief Summary

Not available

Detailed Description

Not available

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
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

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 clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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