Status:
COMPLETED
Efficacy of a Topical Anesthetic Containing Lidocaine and Prilocaine in Treatment With CO2 Fractional Laser
Lead Sponsor:
Galeno Desenvolvimento de Pesquisas Clínicas
Collaborating Sponsors:
Biolab Sanus Farmaceutica
Conditions:
Lidocaine Adverse Reaction
Prilocaine Adverse Reaction
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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 las...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
June 7 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 25 2014
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03366246
Start Date
June 7 2014
End Date
July 25 2014
Last Update
December 8 2017
Active Locations (1)
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1
Clinica Gobbato de Medicina e Dermatologia
Rio Claro, São Paulo, Brazil, 13501105