Working...
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

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.

Condition or disease Intervention/treatment Phase
Tattoo Acne Keloidalis Nuchae Drug: 2,5% lidocaine / 2,5% prilocaine cream Drug: 7% lidocaine / 7% tetracaine cream Device: Neodymium-doped yttrium aluminium garnet (Nd:Yag) laser Device: Q-switched nd Yag laser Phase 4

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : November 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
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.
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.

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.
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: 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.




Primary Outcome Measures :
  1. Self-reported pain (10 point visual analog scale). [ Time Frame: 5 minutes ]

Secondary Outcome Measures :
  1. adequate pain relief (yes/no); [ Time Frame: 10 minutes ]
  2. willing to spend around 25 euro for best pain relief (yes/no). [ Time Frame: 10 minutes ]
  3. To monitor the nature and frequency of adverse events [ Time Frame: one week ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02372786


Locations
Layout table for location information
Netherlands
Erasmus MC
Rotterdam, Zuid-Holland, Netherlands, 3015CA
Sponsors and Collaborators
Erasmus Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Martijn van Doorn, MD, PhD Erasmus MC

Layout table for additonal information
Responsible Party: M.B.A. van Doorn, MD, PhD, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT02372786     History of Changes
Other Study ID Numbers: MEC-2014-517_OPTICA
First Posted: February 26, 2015    Key Record Dates
Last Update Posted: January 20, 2016
Last Verified: January 2016

Keywords provided by M.B.A. van Doorn, Erasmus Medical Center:
7% lidocaine / 7% tetracaine cream
2,5% lidocaine / 2,5% prilocaine cream

Additional relevant MeSH terms:
Layout table for MeSH terms
Acne Keloid
Keloid
Collagen Diseases
Connective Tissue Diseases
Acneiform Eruptions
Skin Diseases
Folliculitis
Hair Diseases
Lidocaine
Prilocaine
Tetracaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action