Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02372786
Recruitment Status : Completed
First Posted : February 26, 2015
Last Update Posted : January 20, 2016
Sponsor:
Information provided by (Responsible Party):
M.B.A. van Doorn, Erasmus Medical Center

Tracking Information
First Submitted Date  ICMJE February 12, 2015
First Posted Date  ICMJE February 26, 2015
Last Update Posted Date January 20, 2016
Study Start Date  ICMJE November 2014
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 20, 2015)
Self-reported pain (10 point visual analog scale). [ Time Frame: 5 minutes ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2015)
  • adequate pain relief (yes/no); [ Time Frame: 10 minutes ]
  • willing to spend around 25 euro for best pain relief (yes/no). [ Time Frame: 10 minutes ]
  • To monitor the nature and frequency of adverse events [ Time Frame: one week ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 20, 2015)
  • adequate pain relief (yes/no); [ Time Frame: 10 minutes ]
  • willing to spend around 25 euro for best pain relief (yes/no). [ Time Frame: Same day as treatment ]
  • To monitor the nature and frequency of adverse events [ Time Frame: one week ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 7% Lidocaine/7% Tetracaine Cream Versus 2,5% Lidocaine / 2,5% Prilocaine Cream
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Tattoo
  • Acne Keloidalis Nuchae
Intervention  ICMJE
  • 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.
    Other Name: Emla®
  • Drug: 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.
    Other Name: Pliaglis®
  • 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.
  • Device: 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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: 2,5% lidocaine / 2,5% prilocaine cream
    • Drug: 7% lidocaine / 7% tetracaine cream
    • Device: Neodymium-doped yttrium aluminium garnet (Nd:Yag) laser
  • 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.
    Interventions:
    • Drug: 2,5% lidocaine / 2,5% prilocaine cream
    • Drug: 7% lidocaine / 7% tetracaine cream
    • Device: Q-switched nd Yag laser
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 20, 2015)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02372786
Other Study ID Numbers  ICMJE MEC-2014-517_OPTICA
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party M.B.A. van Doorn, Erasmus Medical Center
Study Sponsor  ICMJE Erasmus Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Martijn van Doorn, MD, PhD Erasmus MC
PRS Account Erasmus Medical Center
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP