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Efficacy and Safety of a New Botulinum Toxin Type A for Treatment of Facial Expression Lines

NCT01180348 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2016-03-04

No results posted yet for this study

Summary

The dermatological treatment for reducing facial wrinkles with injectable drug Botulift (botulinum toxin type A - Laboratório Químico Farmacêutico BergamoLtd.) has a not inferior activity when compared with Botox ® (botulinum toxin - Allergan Inc.) in clinical trials.

Conditions

  • Wrinkles

Interventions

DRUG

Botulift

Application of 90 U of Botulift divided in 3 applications on each side of the face in fifteen predetermined sites in three regions of the face (front, glabellar, periocular).

DRUG

Botox

Application of 90 U of Botox divided in 3 applications on each side of the face in fifteen predetermined sites in three regions of the face (front, glabellar, periocular).

Sponsors & Collaborators

  • Laboratório Químico Farmacêutico Bergamo Ltda.

    collaborator INDUSTRY

  • Azidus Brasil

    lead INDUSTRY

Principal Investigators

  • Regina M. Doi, Doctor · LAL Clinical Reseach e Development Ltda

  • Alexandre Frederico, Doctor · LAL Clinical Reseach e Development Ltda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2011-10-31
Completion
2012-09-30

Countries

  • Brazil

Study Locations

More Related Trials

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 NCT01180348 on ClinicalTrials.gov