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

NCT03366246 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2017-12-08

No results posted yet for this study

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

Interventions

DRUG

Lidocaine / Prilocaine Cream

according randomized this side received placebo or active product

DRUG

placebo

according randomized this side received placebo or active product

Sponsors & Collaborators

  • Biolab Sanus Farmaceutica

    collaborator INDUSTRY

  • Galeno Desenvolvimento de Pesquisas Clínicas

    lead OTHER_GOV

Principal Investigators

  • Gilberto De Nucci, MD · Galeno Desenvolvimento de Pesquisas Clinicas Ltda. - ME

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-06-07
Primary Completion
2014-07-25
Completion
2014-07-25

Countries

  • Brazil

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03366246 on ClinicalTrials.gov