7% Lidocaine/7% Tetracaine Cream Versus 2,5% Lidocaine / 2,5% Prilocaine Cream
NCT ID: NCT02372786
Last Updated: 2016-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
30 participants
INTERVENTIONAL
2014-11-30
2015-09-30
Brief Summary
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Detailed Description
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* assess the severity of pain experienced (VAS score) during laser treatment,
* evaluate whether the pain relief is adequate and,
* evaluate the amount of money patients would be willing to pay for the cream that provided the 'best' pain relief.
One week after the visit the patient will have a telephone consultation. The patients will be asked if they experienced any symptoms, which will be recorded as adverse events.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Study Groups
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Acne Keloidalis Nuchae
2,5% lidocaine / 2,5% prilocaine cream and 7% lidocaine / 7% tetracaine cream will be applied for 60 minutes. After removal of the creams patients will recieve laser hair removal treatment using a neodymium-doped yttrium aluminium garnet (Nd:Yag) laser.
2,5% lidocaine / 2,5% prilocaine cream
The treatment area will be divided in two equal parts with white markings. Between these two areas an area of 1 cm will be marked. This area will be left untreated, to avoid possible spill-over effects of the two anaesthetic creams. A thick layer of 2,5% lidocaine / 2,5% prilocaine cream will be applied on one side to the intact skin under plastic occlusion (average of 1,5-2g per 10 cm2) 60 minutes before laser treatment.
7% lidocaine / 7% tetracaine cream
The treatment area will be divided in two equal parts with white markings. Between these two areas an area of 1 cm will be marked. This area will be left untreated, to avoid possible spill-over effects of the two anaesthetic creams. A thin layer of 7% lidocaine / 7% tetracaine cream (1mm) will be applied on the other side to the intact skin (average of 1,3g Pliaglis per 10 cm2) 60 minutes before laser treatment.
Neodymium-doped yttrium aluminium garnet (Nd:Yag) laser
Acne keloidalis nuchae: during this study a 1064 nm Nd:yag laser with a spot size of 7-10 mm, and a fluence of 35-60J/cm2, (depending on the effective and safe clinical response), a pulse duration of 20-35 ms and 2 passes will be used.
Tattoo
2,5% lidocaine / 2,5% prilocaine cream and 7% lidocaine / 7% tetracaine cream will be applied for 60 minutes. After removal of the creams patients will recieve laser tattoo removal treatment using a Q-switched nd Yag laser.
2,5% lidocaine / 2,5% prilocaine cream
The treatment area will be divided in two equal parts with white markings. Between these two areas an area of 1 cm will be marked. This area will be left untreated, to avoid possible spill-over effects of the two anaesthetic creams. A thick layer of 2,5% lidocaine / 2,5% prilocaine cream will be applied on one side to the intact skin under plastic occlusion (average of 1,5-2g per 10 cm2) 60 minutes before laser treatment.
7% lidocaine / 7% tetracaine cream
The treatment area will be divided in two equal parts with white markings. Between these two areas an area of 1 cm will be marked. This area will be left untreated, to avoid possible spill-over effects of the two anaesthetic creams. A thin layer of 7% lidocaine / 7% tetracaine cream (1mm) will be applied on the other side to the intact skin (average of 1,3g Pliaglis per 10 cm2) 60 minutes before laser treatment.
Q-switched nd Yag laser
Tattoo removal: we will use a 3 mm spotsize and a fluence depending on the absorption of the laser light, which is visible as skin whitening.
Interventions
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2,5% lidocaine / 2,5% prilocaine cream
The treatment area will be divided in two equal parts with white markings. Between these two areas an area of 1 cm will be marked. This area will be left untreated, to avoid possible spill-over effects of the two anaesthetic creams. A thick layer of 2,5% lidocaine / 2,5% prilocaine cream will be applied on one side to the intact skin under plastic occlusion (average of 1,5-2g per 10 cm2) 60 minutes before laser treatment.
7% lidocaine / 7% tetracaine cream
The treatment area will be divided in two equal parts with white markings. Between these two areas an area of 1 cm will be marked. This area will be left untreated, to avoid possible spill-over effects of the two anaesthetic creams. A thin layer of 7% lidocaine / 7% tetracaine cream (1mm) will be applied on the other side to the intact skin (average of 1,3g Pliaglis per 10 cm2) 60 minutes before laser treatment.
Neodymium-doped yttrium aluminium garnet (Nd:Yag) laser
Acne keloidalis nuchae: during this study a 1064 nm Nd:yag laser with a spot size of 7-10 mm, and a fluence of 35-60J/cm2, (depending on the effective and safe clinical response), a pulse duration of 20-35 ms and 2 passes will be used.
Q-switched nd Yag laser
Tattoo removal: we will use a 3 mm spotsize and a fluence depending on the absorption of the laser light, which is visible as skin whitening.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject is ≥ 18 years of age at time of screening;
* Group A: subjects with acne keloidalis nuchae;
* Group B: subjects with an uniform, black, professionally placed tattoo
Exclusion Criteria
* 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.
18 Years
ALL
Yes
Sponsors
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Erasmus Medical Center
OTHER
Responsible Party
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M.B.A. van Doorn
MD, PhD
Principal Investigators
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Martijn van Doorn, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Erasmus Medical Center
Locations
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Erasmus MC
Rotterdam, South Holland, Netherlands
Countries
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Other Identifiers
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MEC-2014-517_OPTICA
Identifier Type: -
Identifier Source: org_study_id
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