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7% Lidocaine/7% Tetracaine Cream Versus 2,5% Lidocaine / 2,5% Prilocaine Cream (OPTICA)

Primary Purpose

Tattoo, Acne Keloidalis Nuchae

Status
Completed
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
2,5% lidocaine / 2,5% prilocaine cream
7% lidocaine / 7% tetracaine cream
Neodymium-doped yttrium aluminium garnet (Nd:Yag) laser
Q-switched nd Yag laser
Sponsored by
Erasmus Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tattoo focused on measuring 7% lidocaine / 7% tetracaine cream, 2,5% lidocaine / 2,5% prilocaine cream

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Erasmus MC

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Acne Keloidalis Nuchae

Tattoo

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Self-reported pain (10 point visual analog scale).

Secondary Outcome Measures

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

Full Information

First Posted
February 12, 2015
Last Updated
January 19, 2016
Sponsor
Erasmus Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02372786
Brief Title
7% Lidocaine/7% Tetracaine Cream Versus 2,5% Lidocaine / 2,5% Prilocaine Cream
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erasmus Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tattoo, Acne Keloidalis Nuchae
Keywords
7% lidocaine / 7% tetracaine cream, 2,5% lidocaine / 2,5% prilocaine cream

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acne Keloidalis Nuchae
Arm Type
Other
Arm Description
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.
Arm Title
Tattoo
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
2,5% lidocaine / 2,5% prilocaine cream
Other Intervention Name(s)
Emla®
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
7% lidocaine / 7% tetracaine cream
Other Intervention Name(s)
Pliaglis®
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Neodymium-doped yttrium aluminium garnet (Nd:Yag) laser
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Q-switched nd Yag laser
Intervention Description
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.
Primary Outcome Measure Information:
Title
Self-reported pain (10 point visual analog scale).
Time Frame
5 minutes
Secondary Outcome Measure Information:
Title
adequate pain relief (yes/no);
Time Frame
10 minutes
Title
willing to spend around 25 euro for best pain relief (yes/no).
Time Frame
10 minutes
Title
To monitor the nature and frequency of adverse events
Time Frame
one week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martijn van Doorn, MD, PhD
Organizational Affiliation
Erasmus Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Erasmus MC
City
Rotterdam
State/Province
Zuid-Holland
ZIP/Postal Code
3015CA
Country
Netherlands

12. IPD Sharing Statement

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

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