7% Lidocaine/7% Tetracaine Cream Versus 2,5% Lidocaine / 2,5% Prilocaine Cream
Information source: Erasmus Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Tattoo; Acne Keloidalis Nuchae
Intervention: 2,5% lidocaine / 2,5% prilocaine cream (Drug); 7% lidocaine / 7% tetracaine cream (Drug); Neodymium-doped yttrium aluminium garnet (Nd:Yag) laser (Device); Q-switched nd Yag laser (Device)
Phase: Phase 4
Status: Recruiting
Sponsored by: Erasmus Medical Center Official(s) and/or principal investigator(s): Martijn van Doorn, MD, PhD, Principal Investigator, Affiliation: Erasmus MC
Overall contact: Karin Greveling, Phone: +31107032063, Email: k.greveling@erasmusmc.nl
Summary
The purpose of this study is to compare the efficacy of 7% lidocaine / 7% tetracaine cream
and 2,5% lidocaine / 2,5% prilocaine cream in reducing self-reported pain during a single
laser procedure in the treatment of acne keloidalis nuchae and tattoo removal.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Self-reported pain (10 point visual analog scale).
Secondary outcome: adequate pain relief (yes/no);willing to spend around 25 euro for best pain relief (yes/no). To monitor the nature and frequency of adverse events
Detailed description:
In this study we will compare the efficacy of 7% lidocaine / 7% tetracaine cream and 2,5%
lidocaine / 2,5% prilocaine cream in reducing self-reported pain during a single laser
procedure in the treatment of acne keloidalis nuchae and tattoo removal. Patients will be
asked to fill in questionnaires to:
- 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- • Subject has provided written informed consent;
- 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:
- • 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.
Locations and Contacts
Karin Greveling, Phone: +31107032063, Email: k.greveling@erasmusmc.nl
Erasmus MC, Rotterdam, Zuid-Holland 3015CA, Netherlands; Recruiting Greveling, Email: k.greveling@erasmusmc.nl
Additional Information
Starting date: November 2014
Last updated: August 7, 2015
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