A double blind randomized controlled trial comparing the efficacy of two anaesthetic creams for local anaesthesia during laser treatment.

• Conditions: Pain during laser treatment of:1. Tattoo 2. Acne keloidalis nuchae; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2014-003610-86-NL

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-01
• Last Update Posted: 24 November 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•Subject has provided informed consent;
•Subject is = 18 years of age at time of screening;
•Group A: subjects with Fitzpatrick skintype V or VI and acne keloidalis nuchae;
•Group B: subjects with an uniform, black, professionally placed tattoo.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified