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

March 3, 2016 updated by: Azidus Brasil

Randomized Study of Clinical Non-inferiority of Medicine Botulift (Laboratório Químico Farmacêutico Bergamo Ltd.) Compared to Botox ® (Allergan Inc.) in the Improvement of Wrinkles in the Facial Region.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will evaluate non-inferiority in clinical improvement in the intensity of expression lines over 16 weeks of drug Botulift (Laboratório Químico Farmacêutico Bergamo Ltd.) compared with Botox ® (Allergan Inc.). So that the homogeneity of the group opted to use in female patients with glabellar wrinkles grade 2 (moderate) and 3 (severe) Scale Standard Facial Wrinkles, established by Honecker et al. (2003). The first area of the face perceived in mime is the glabellar complex, located in the space between the eyebrows, wrinkles eventually show (Almeida et al., 2010).

Patients will be evaluated at each visit, the doctor Principal Investigator and digital photos of the glabellar region at maximum contraction and relaxation will be obtained using the apparatus Visia (Canfield Imaging Systems, version 4.0.2) for further analysis by random team dermatologists.

Study Type

Interventional

Enrollment (Actual)

192

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Sao Paulo
      • Valinhos, Sao Paulo, Brazil, 13276254
        • LAL Clínica Pesquisa e Desenvolvimento Ltda

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients who agree with all study procedures and sign for their own free will the TCLE;
  • Adult patients were female between 18 and 65 years, regardless of social condition;
  • between skin phototype I and IV;
  • With good mental and physical health;
  • Patients who have not been treated with botulinum toxin type A;
  • Patients who agree to abstain from physical activity for a period of 24 hours, previous and subsequent to the initiation of the study;
  • Patients presenting at screening visit, wrinkles in the glabellar region between classes 2 and 3 of Table Wrinkles Pattern Classification, which is diagnosed clinically by the dermatologist.

Exclusion Criteria:

  • Patients who are in classes 0 and 1 of the Table Pattern Classification Wrinkle;
  • Patients who have disorders or diseases that might interfere with neuromuscular function (myasthenia gravis or Lambert-Eaton syndrome);
  • Patients being treated with antibiotics (aminoglycosides) and muscle relaxants;
  • Patients with pre-existing conditions such as ptosis or scars in the area to be assessed, as they may endanger the health of the patient and the results of the study;
  • Patients who have made treatments fill in the glabellar region (retinoic acid, collagen);
  • Patients who have been treated in the dermatological peeling úlitmos three months;
  • Patients are using treatments dermacosmetics agents anti age (vitamin C pure retinoids flavanoids acid hyaluronic others) or used past 3 months
  • Patients with known hypersensitivity to any component of the study drug;
  • Pregnant or lactating women;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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: 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).
Other Names:
  • Botulinum Toxin Type A
Active Comparator: 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).
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).
Other Names:
  • Botulinum Toxin Type A

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall improved assessment of hyperkinetic facial lines in a state of relaxation and maximal contraction through the Honeck's scale and photographic images obtained by equipment Visia Digital Compexton Analysis (Canfield Imaging Systems, version 4.0.2)
Time Frame: after 30 days of application
The non-inferiority of T group compared to the group Co was demonstrated in evaluations in a state of relaxation and maximal contraction in the PP analysis population, because as defined for the study, the lower limits of 95% of the mean of these assessments (-2 , 7% and -5.4%) are contained within the non-inferiority limit set at -10%.
after 30 days of application

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of stay of the effect of botulinum toxin A (Test and Comparator)
Time Frame: during the 24-week period
The action of both treatments decreases over time and there is no significant difference between the two treatments.
during the 24-week period
Safety of both botulinum toxin A
Time Frame: during the whole period
The occurrence of adverse events was similar in both groups.
during the whole period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azidus Brasil

Collaborators

Laboratório Químico Farmacêutico Bergamo Ltda.

Investigators

  • Principal Investigator: Alexandre Frederico, Doctor, LAL Clinical Reseach e Development Ltda
  • Principal Investigator: Regina M. Doi, Doctor, LAL Clinical Reseach e Development Ltda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

August 10, 2010

First Submitted That Met QC Criteria

August 11, 2010

First Posted (Estimate)

August 12, 2010

Study Record Updates

Last Update Posted (Estimate)

March 4, 2016

Last Update Submitted That Met QC Criteria

March 3, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TOXBER0610

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

The study data will be maked available after journal's approbation. The manuscript contained all of data it has been submitted.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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