Efficacy of a Topical Anesthetic Containing Lidocaine and Prilocaine in Treatment With CO2 Fractional Laser

NCT03366246 | Completed Phase 3

• 1 other identifier: GDN 051/13
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lidocaine Adverse Reaction; Prilocaine Adverse Reaction

Keywords

topical anesthetic; nanocapsules; nanotechnology; lidocaine; prilocaine; fractional CO2 laser resurfacing

Outcome Measures

Primary Outcomes (4)

• 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.

• 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.

• 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

• 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 Outcomes (1)

• Adverse Event Incidence

  at 0:50, 1:20 and 1:50 minutes after cream application

Other Outcomes (1)

• Lidocaine and Prilocaine Plasma Concentration

  0 - 12 hours

Study Arms (2)

lidocaine / prilocaine cream

ACTIVE COMPARATOR

according to randomization 2g topical nano anesthetic ( lidocaine 25mg/g and prilociane 25mg/g )was applied to one side ( left or right ) of the forehead 20 minutes before laser therapy.

Drug: Lidocaine / Prilocaine Cream

placebo

PLACEBO COMPARATOR

according to randomization 2g of the placebo( nano anesthetic vehicle with no active ingredient ) was applied to one side ( left or right) of the forehead 20 minutes before laser therapy.

Drug: placebo

Interventions

Lidocaine / Prilocaine Cream DRUG

according randomized this side received placebo or active product

lidocaine / prilocaine cream

placebo DRUG

according randomized this side received placebo or active product

placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female or male patients with phototypes I to III and older than 18 years and less than 70 years;
• Indication of aesthetic treatment with CO2 fractional laser in the forehead;
• Absence of treatment in the forehead that, at the discretion of the clinical investigator, may interfere with the objectives of the study;
• Absence of allergic skin reactions on the face;
• 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;
• 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.

You may not qualify if:

• The volunteer has known hypersensitivity to chemically related compounds; history of serious adverse reactions or hypersensitivity to any drug;
• Known hypersensitivity to lidocaine, prilocaine, vehicle of the investigational product (gel) or to chemically related compounds; history of serious adverse reactions;
• History of congenital or idiopathic methemoglobinemia
• 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 ;
• History of alcohol or drug abuse;
• Treatment, within 3 months prior to the study, with any drug known to have a well-defined toxic potential in large organs;
• 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.

Sponsors & Collaborators

• Galeno Desenvolvimento de Pesquisas Clínicas: lead
• Biolab Sanus Farmaceutica: collaborator

Study Sites (1)

Clinica Gobbato de Medicina e Dermatologia

Rio Claro, São Paulo, 13501105, Brazil

Location

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Gilberto De Nucci, MD

  Galeno Desenvolvimento de Pesquisas Clinicas Ltda. - ME

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 1 tube containing anesthetic and 1 tube containing placebo, both with the same aspect (same vehicle) were randomized in respect of which side each formulation should be applied. Tubes were labeled with the subject number and the indication of LEFT or RIGHT side for application. Therefore, these identical tubes, no longer possible to distinguish whether a particular tube was referring to test or control formulation. Those responsible for the separation did not participate in the conduct of activities of the study.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Director and Principal Investigator

Model Details: Double-blind, crossover study where the same participant received in one side of the forehead the active drug and in the other side of the forehead placebo.

Study Record Dates

• First Submitted: November 22, 2017
• First Posted: December 8, 2017
• Study Start: June 7, 2014
• Primary Completion: July 25, 2014
• Study Completion: July 25, 2014
• Last Updated: December 8, 2017

Record last verified: 2017-12

Locations

BR (1)