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

NCT02372786 | Completed Phase 4

• 1 other identifier: MEC-2014-517_OPTICA
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Tattoo; Acne Keloidalis Nuchae

Keywords

7% lidocaine / 7% tetracaine cream; 2,5% lidocaine / 2,5% prilocaine cream

Outcome Measures

Primary Outcomes (1)

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

  5 minutes

Secondary Outcomes (3)

• adequate pain relief (yes/no);

  10 minutes

• willing to spend around 25 euro for best pain relief (yes/no).

  10 minutes

• To monitor the nature and frequency of adverse events

  one week

Study Arms (2)

Acne Keloidalis Nuchae

OTHER

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; Drug: 7% lidocaine / 7% tetracaine cream; Device: Neodymium-doped yttrium aluminium garnet (Nd:Yag) laser

Tattoo

OTHER

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; Drug: 7% lidocaine / 7% tetracaine cream; Device: Q-switched nd Yag laser

Interventions

2,5% lidocaine / 2,5% prilocaine cream DRUG

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.

Also known as: Emla®

Acne Keloidalis Nuchae; Tattoo

7% lidocaine / 7% tetracaine cream DRUG

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.

Also known as: Pliaglis®

Acne Keloidalis Nuchae; Tattoo

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

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.

Acne Keloidalis Nuchae

Q-switched nd Yag laser DEVICE

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.

Tattoo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus MC

Rotterdam, South Holland, 3015CA, Netherlands

Location

MeSH Terms

Conditions

Acne Keloid

Interventions

Lidocaine, Prilocaine Drug Combination; Lidocaine; Lasers

Condition Hierarchy (Ancestors)

Keloid; Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Acneiform Eruptions; Skin Diseases; Folliculitis; Hair Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Prilocaine; Aniline Compounds; Amines; Drug Combinations; Pharmaceutical Preparations; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Martijn van Doorn, MD, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: February 12, 2015
• First Posted: February 26, 2015
• Study Start: November 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: January 20, 2016

Record last verified: 2016-01

Locations

NL (1)