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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

Page last updated: August 23, 2015

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