7% Lidocaine/7% Tetracaine Cream Versus 2,5% Lidocaine / 2,5% Prilocaine Cream

Acne Keloidalis Nuchae Clinical Trial

— OPTICA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02372786
• Other study ID #: MEC-2014-517_OPTICA
• Status: Completed
• Phase: Phase 4
• First received: February 12, 2015
• Last updated: January 19, 2016
• Start date: November 2014
• Est. completion date: September 2015

Study information

• Verified date: January 2016
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acne Keloid
• Acne Keloidalis Nuchae
• Tattoo

Intervention

Drug:
• 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.

Device:
• 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.

Locations

Country	Name	City	State
Netherlands	Erasmus MC	Rotterdam	Zuid-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-reported pain (10 point visual analog scale).		5 minutes	No
Secondary	adequate pain relief (yes/no);		10 minutes	No
Secondary	willing to spend around 25 euro for best pain relief (yes/no).		10 minutes	Yes
Secondary	To monitor the nature and frequency of adverse events		one week	No