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

PHASE4CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

November 30, 2014

Primary Completion Date

September 30, 2015

Study Completion Date

September 30, 2015

Conditions
TattooAcne Keloidalis Nuchae
Interventions
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.

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.

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.

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.

Trial Locations (1)

3015CA

Erasmus MC, Rotterdam

Sponsors
All Listed Sponsors
lead

Erasmus Medical Center

OTHER

NCT02372786 - 7% Lidocaine/7% Tetracaine Cream Versus 2,5% Lidocaine / 2,5% Prilocaine Cream | Biotech Hunter | Biotech Hunter