Lidocaine Adverse Reaction Clinical Trial
Official title:
A Double-blind, Monocentric, Phase 3 Clinical Study for the Evaluation of Efficacy of a Topical Anesthetic Containing Lidocaine 25mg/g and Prilocaine 25mg/g in Adult Patients of Phototypes I to III in Treatment With CO2 Fractional Laser
This is a study aimed at evaluating the efficacy of a topical anesthesia (test product)
compared to placebo in adult patients of phototypes I to III, with indication of treatment of
CO2 fractional laser in the forehead. In addition to efficacy, safety and tolerability of the
product have been studied.
The product under investigation is a topical formulation containing lidocaine 25 mg/g and
prilocaine 25mg/g which in previous studies performed in the same institution with healthy
subjects in adulthood showed faster onset than other formulations. In these previous studies,
the product was well tolerated, and there were no signs of a skin reaction or adverse events
of a systemic nature.
The CO2 fractional laser treatment is routinely used by plastic surgery and dermatology for
treatment with aesthetic purposes of skin imperfections. It's a procedure until certain
painful point, which as a rule is performed without prior use of topical anesthetic.
The test product is believed to produce a clinically significant reduction of pain when
compared to placebo, during the application of CO2 laser on the forehead for the aesthetic
treatment of the face.
The study was designed to allow assessing the efficacy of the product compared to placebo
when applied to reduce pain resulting from treatment of the forehead with CO2 fractional
laser at 5 mJ fluency and 5% concentration. To assess possible reactions, the photographic
records were taken prior to the application of both products, as well as immediately prior to
laser therapy and after 1 hour of laser therapy (1:20 h of application of the products).
In addition to the efficacy evaluation, the concomitant application of the control product
(placebo) aimed to verify if possible dermatological reactions would be related to the active
principle of the product or to the components of the cream base or to the performance of the
laser therapy. In addition, considering a subgroup of participants, the study allowed the
assessment of the degree of systemic absorption from the plasma concentrations observed,
through the collection of blood samples for quantification of the compounds after their
topical application.
Phase III, double-blind, monocentric, randomized crossover at the same time (right and left
sides of forehead) , consisting of 120 patients, phototypes I to III, older than 18 years,
female or male, with indication of aesthetic treatment with carbon dioxide (CO2) fractional
laser in the forehead.
The anesthetic formulation, the object of the study, was administered topically in one side
of the forehead and the placebo formulation (vehicle of the product) in the opposite side,
once, as randomized, twenty minutes before the start of the CO2 laser therapy (in both sides
of the forehead).
A total of 120 samples (5 g tubes) of the Test formulation and 120 samples (5 g tubes) of the
Control (placebo) formulation were prepared for the administration of the medication to study
. Initially, based on identification only on the secondary packaging (labeled plastic bag
containing only test formulation tubes and labeled plastic bag containing only control
formulation tubes), the tubes of each formulation were labeled with the subject's subject
number and the indication of the side ( left or right ) of application, according to
randomization of the study. After labeling and proper conferencing, these identical looking
tubes were assembled and sorted by the participant number and left or right , and it was no
longer possible to distinguish whether a particular tube concerned the test or control
formulation. This set of samples was forwarded for conducting the study. Those responsible
for the separation did not participate in the conduct of the study activities.
The study population consisted of female or male patients, phototypes I to III, with good
general health conditions and those older than 18 years who had indication of aesthetic
treatment with CO2 fractional laser compatible with the study proposal . These patients
attended the clinic either spontaneously.
The anesthetic formulation and placebo were weighed individually, 2g of each gel, placing
them directly on a spatula identified as left or right side, on a semi-analytical scale. The
contents on the spatulas were applied to the corresponding forehead side using the gloved
finger of the applicator to spread it as evenly as possible, 20 minutes before the session
with CO2 fractional laser, under the supervision of the clinical investigator. Both test
product and placebo gel were removed with saline solution and then CO2 laser intensity of 5mJ
and concentration of 5% was applied across the forehead, always starting the right side
toward the left side.
Immediately (0 min) after laser application and at 30, 60 and 90 minutes, it was assessed
pain sensation in four quadrants of each forehead side using a visual analogue scale. The
scale consists of a continuous line, whose left end corresponding to the absence of pain ("No
Pain") and right end corresponding to the worst pain bearable by the patient ("the worst pain
you can imagine"). The patient scored a perpendicular mark anywhere on the line (including
the ends) in position to understand better represent the intensity of pain experienced on
that quadrant at the specific time of each evaluation.
The evaluations were completed after 90 minutes of laser session (110 minutes after treatment
with the investigational products) and blood pressure, pulse and temperature measurements
were performed before the patient was released. At the end of the study, the distance from
the left end to the mark was measured with a millimeter scale ruler. Two independent persons
performed this measurement and any discrepancies values were conferred by a third person.
At the end of the procedure was generated a table in Excel, also conferred with the values
obtained in centimeters for each occasion, including the total length of the ruler. The value
in percentage was obtained by dividing the measured value by the total length of the scale by
100 . The averaged response corresponding to the four quadrants on the left and the average
of the responses corresponding to the four quadrants on the right was calculated.
The two values (mean of the left side and mean of the right side) obtained for each of the
occasions was the value used for the statistical calculation of treatment efficacy. A mean
reduction of 30% with the topical anesthetic versus placebo - test / placebo ≤0.7 was
considered clinically significant . The statistical analysis used for efficacy was the paired
t-test.
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