Lidocaine Adverse Reaction Clinical Trial
— CO2Official 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
Verified date | December 2017 |
Source | Galeno Desenvolvimento de Pesquisas Clínicas |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 120 |
Est. completion date | July 25, 2014 |
Est. primary completion date | July 25, 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: 1. Female or male patients with phototypes I to III and older than 18 years and less than 70 years; 2. Indication of aesthetic treatment with CO2 fractional laser in the forehead; 3. Absence of treatment in the forehead that, at the discretion of the clinical investigator, may interfere with the objectives of the study; 4. Absence of allergic skin reactions on the face; 5. Lack of other significant diseases that, according to the criteria defined in this protocol, may be impacted by the medical criteria, and the evaluations to which it was submitted: clinical history, physical examination, ECG; 6. Capable of understanding the nature and purpose of the study, including risks and adverse effects, and intending to cooperate with the researcher and to act according to the requirements of the entire study, by signing the Informed Consent Form. Exclusion Criteria: 1. The volunteer has known hypersensitivity to chemically related compounds; history of serious adverse reactions or hypersensitivity to any drug; 2. Known hypersensitivity to lidocaine, prilocaine, vehicle of the investigational product (gel) or to chemically related compounds; history of serious adverse reactions; 3. History of congenital or idiopathic methemoglobinemia 4. Current evidence of clinically significant diseases of gastrointestinal, cardiovascular, hepatic, renal, pulmonary, or other origin that prevent patient participation in the study and / or, at the discretion of the clinical investigator, expose the patient to additional risk ; 5. History of alcohol or drug abuse; 6. Treatment, within 3 months prior to the study, with any drug known to have a well-defined toxic potential in large organs; 7. Participation in any experimental study or ingestion of any experimental drug within six months prior to the start of this study; 8 .Positive pregnancy test , delivery or abortion in the 12 weeks prior to the scheduled start of treatment; 9 .Any condition that prevents the patient from participating in the study, according to the researcher's criteria. |
Country | Name | City | State |
---|---|---|---|
Brazil | Clinica Gobbato de Medicina e Dermatologia | Rio Claro | SP |
Lead Sponsor | Collaborator |
---|---|
Galeno Desenvolvimento de Pesquisas Clínicas | Biolab Sanus Farmaceutica |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Lidocaine and Prilocaine Plasma Concentration | Eight of the 120 participants also took part in blood sampling for dosing plasma concentrations from blood samples taken at 0:00, 0:10, 0:20, 0:30, 0:40, 0:50, 1:00, 1:10, 1:20, 1:30, 1:40, 1:50, 2:00, 2:20, 2:40, 3:00, 3:30, 4:00, 5:00, 6:00, 7:00, 8:00, 10:00 and 12:00 hours after the application, in order to characterize the general pharmacokinetic profile | 0 - 12 hours | |
Primary | Pain assessed by means of a visual analog scale | The aim of this present study was to evaluate the efficacy of this new product compared to placebo when applied to the forehead of patients submitted to fractional CO2 laser, using a visual analog scale (VAS).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 | at 0 minutes after laser therapy with CO2 fractional laser. | |
Primary | Pain assessed by means of a visual analog scale | The aim of this present study was to evaluate the efficacy of this new product compared to placebo when applied to the forehead of patients submitted to fractional CO2 laser, using a visual analog scale (VAS).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. | at 30 minutes after laser therapy with CO2 fractional laser. | |
Primary | Pain assessed by means of a visual analog scale | The aim of this present study was to evaluate the efficacy of this new product compared to placebo when applied to the forehead of patients submitted to fractional CO2 laser, using a visual analog scale (VAS).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. | at 60 minutes after laser therapy with CO2 fractional laser | |
Primary | Pain assessed by means of a visual analog scale | The aim of this present study was to evaluate the efficacy of this new product compared to placebo when applied to the forehead of patients submitted to fractional CO2 laser, using a visual analog scale (VAS).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. | at 90 minutes after laser therapy with CO2 fractional laser | |
Secondary | Adverse Event Incidence | As secondary objective were to evaluate the safety of possible dermatological reactions | at 0:50, 1:20 and 1:50 minutes after cream application |
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