EUCTR2014-003610-86-NL
Active, not recruiting
Not Applicable
A double blind randomized controlled trial comparing the efficacy of 7% lidocaine / 7% tetracaine cream versus 2,5% lidocaine / 2,5% prilocaine cream for local anaesthesia during laser treatment of acne keloidalis nuchae and tattoo removal.
Not provided0 sitesOctober 1, 2014
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pain during laser treatment of:1. Tattoo 2. Acne keloidalis nuchae
- Sponsor
- Not provided
- Status
- Active, not recruiting
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject has provided informed consent;
- •Subject is \= 18 years of age at time of screening;
- •Group A: subjects with Fitzpatrick skintype V or VI and acne keloidalis nuchae;
- •Group B: subjects with an uniform, black, professionally placed tattoo.
- •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 25
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 5
Exclusion Criteria
- •Known sensitivity to any components of the test materials;
- •Pregnant or breast\-feeding women;
- •Use of any other pain medication during past 24 hours prior to the laser treatment;
- •Damaged skin at the designated treatment site;
- •Blister formation and/or scar formation after test\-treatment with standard laser settings;
- •Any medical or psychiatric condition which, in the investigator’s opinion, would preclude the participant from adhering to the protocol or completing the study per protocol.
Outcomes
Primary Outcomes
Not specified
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