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

Erasmus University

Status and phase: Completed; Phase 4

Conditions: Tattoo; Acne Keloidalis Nuchae

Treatments: Drug: 2,5% lidocaine / 2,5% prilocaine cream; Device: Q-switched nd Yag laser; Drug: 7% lidocaine / 7% tetracaine cream; Device: Neodymium-doped yttrium aluminium garnet (Nd:Yag) laser

Study type: Interventional

Funder types: Other

Identifiers

NCT02372786

MEC-2014-517_OPTICA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Acne Keloidalis Nuchae

Other group

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.

Treatment:

Device: Neodymium-doped yttrium aluminium garnet (Nd:Yag) laser

Drug: 7% lidocaine / 7% tetracaine cream

Drug: 2,5% lidocaine / 2,5% prilocaine cream

Tattoo

Other group

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.

Treatment:

Device: Q-switched nd Yag laser

Drug: 7% lidocaine / 7% tetracaine cream

Drug: 2,5% lidocaine / 2,5% prilocaine cream