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.
ID
Source
Brief title
Condition
- Skin appendage conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Self-reported pain (10 point visual analog scale).
Secondary outcome
- adequate pain relief (yes/no);
- willingness to spend 25 euro for the best pain relief.
Background summary
The product most widely used for local anaesthesia during laser procedures for
dermatological indications is a combination of 2,5% lidocaine and 2,5%
prilocaine cream (EMLA®) and can be considered the gold standard. However, for
some indications, the anaesthetic effect is not sufficient to allow a pain free
and comfortable laser procedure. A newly developed self-occlusive topical 7%
lidocaine / 7% tetracaine anesthetic cream (Pliaglis®) approved by the Food and
Drug Administration (FDA) and European Drug Agency (EMA) is marketed to provide
better local anesthesia for patients undergoing (superficial) dermatological
procedures. This formulation contains the highest concentration of active
anesthetic ingredients available in a topical cream and has shown superior
efficacy in pain reduction versus placebo in several dermatological
indications. However, apart from a single study comparing the efficacy of 7%
lidocaine / 7% tetracaine cream versus 2,5% lidocaine / 2,5% lidocaine cream in
pain reduction for (a single pass) CO2 laser resurfacing, no head-to-head
studies have been performed for any of the other dermatological indications.
Therefore, in this study we will compare the efficacy of 7% lidocaine / 7%
tetracaine cream with 2,5% lidocaine / 2,5% prilocaine cream in pain reduction
during laser hair removal in acne keloidalis nuchae and tattoo removal; two
dermatological conditions, which carry a high need for pain relief.
Study objective
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.
Study design
Double-blind randomised controlled trial with split lesion design.
Intervention
The treatment area will be divided in two equal parts with white markings.
Between this two areas an area of 1cm will be marked. This area will be left
untreated, to avoid possible spill-over effects of the two anaesthetic
creams. Sixty minutes before starting the laser treatment 7% lidocaine / 7%
tetracaine cream will be applied on one part and 2,5% lidocaine / 2,5%
prilocaine cream will be applied on the other part.
Study burden and risks
Patients who are referred to the department for laser treatments are asked to
participate in this study. The study will not require any extra visits for the
participants. 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.
A potential benefit for the participants could be enhanced local anaesthesia
during laser treatment. Both anaesthetic creams are registered to provide local
anaesthesia and are reported to have minimal side effects.
Burg. sJacobplein 51
Rotterdam 3015 CA
NL
Burg. sJacobplein 51
Rotterdam 3015 CA
NL
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2014-003610-86-NL |
| CCMO | NL50770.078.14 |