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

NCT01180348 | Completed Phase 3

• 1 other identifier: TOXBER0610
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Wrinkles, glabellar, facial.

Outcome Measures

Primary Outcomes (1)

• 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)

  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 Outcomes (2)

• Length of stay of the effect of botulinum toxin A (Test and Comparator)

  during the 24-week period

• Safety of both botulinum toxin A

  during the whole period

Study Arms (2)

Botulift

EXPERIMENTAL

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

Botox

ACTIVE COMPARATOR

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

Interventions

Botulift DRUG

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).

Also known as: Botulinum Toxin Type A

Botulift

Botox DRUG

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).

Also known as: Botulinum Toxin Type A

Botox

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Azidus Brasil: lead
• Laboratório Químico Farmacêutico Bergamo Ltda.: collaborator

Study Sites (1)

LAL Clinica Pesquisa e Desenvolvimento Ltda

Valinhos, São Paulo, 13276254, Brazil

Location

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MeSH Terms

Conditions

Facies

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Regina M. Doi, Doctor

  LAL Clinical Reseach e Development Ltda

  PRINCIPAL INVESTIGATOR

• Alexandre Frederico, Doctor

  LAL Clinical Reseach e Development Ltda

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2010
• First Posted: August 12, 2010
• Study Start: August 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: September 1, 2012
• Last Updated: March 4, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will share

Locations

BR (1)