Status:
COMPLETED
Fractional Laser Assisted Delivery of Anesthetics
Lead Sponsor:
Netherlands Institute for Pigment Disorders
Collaborating Sponsors:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Conditions:
Local Anesthesia of the Skin.
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to assess the efficacy of fractional CO2 laser assisted delivery of topically applied anesthetics (articaine hydrochloride 40 mg/ml and epinephrine 10 μg/ml solution and E...
Detailed Description
Rationale: In dermatology, many minor surgical and laser procedures are carried out under local anesthesia of the skin. Anesthesia using topical formulations is time consuming, as the anesthetic has t...
Eligibility Criteria
Inclusion
- Fitzpatrick skin type I or II
- Age ≥18 years
- Patient is willing and able to give written informed consent
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT02246179
Start Date
September 1 2014
End Date
October 1 2014
Last Update
November 10 2014
Active Locations (1)
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1
Netherlands Institute for Pigment disorders
Amsterdam, Netherlands, 1105 AZ