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

This study has been completed.
Sponsor:
Collaborator:
Laboratório Químico Farmacêutico Bergamo Ltda.
Information provided by (Responsible Party):
Azidus Brasil
ClinicalTrials.gov Identifier:
NCT01180348
First received: August 10, 2010
Last updated: March 3, 2016
Last verified: March 2016
  Purpose
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.

Condition Intervention Phase
Wrinkles
Drug: Botulift
Drug: Botox
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Azidus Brasil:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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%.


Secondary Outcome Measures:
  • Length of stay of the effect of botulinum toxin A (Test and Comparator) [ Time Frame: during the 24-week period ] [ Designated as safety issue: Yes ]
    The action of both treatments decreases over time and there is no significant difference between the two treatments.

  • Safety of both botulinum toxin A [ Time Frame: during the whole period ] [ Designated as safety issue: Yes ]
    The occurrence of adverse events was similar in both groups.


Enrollment: 192
Study Start Date: August 2011
Study Completion Date: September 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Botulinum Toxin Type A

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01180348

Locations
Brazil
LAL Clinica Pesquisa e Desenvolvimento Ltda
Valinhos, Sao Paulo, Brazil, 13276254
Sponsors and Collaborators
Azidus Brasil
Laboratório Químico Farmacêutico Bergamo Ltda.
Investigators
Principal Investigator: Regina M. Doi, Doctor LAL Clinical Reseach e Development Ltda
Principal Investigator: Alexandre Frederico, Doctor LAL Clinical Reseach e Development Ltda
  More Information

Publications:
Sposito MMM. Toxina botulínica do tipo A: mecanismo de ação. Acta Fisiatr. 2009;16(1):25-37.
Hexsel D, Mazzuco R, Dal'Forno T, Kraemer C, Lima MM, Prado DZ. Botulinum toxin for Facial Wrinkles: History and Future. Expert Rev. Dermatol. 2(4), 417 - 426 (2007).
Dolly, JO. Therapeutic and Research Exploitation of Botulinum Neurotoxins. Eur J Neurol. 1997;4:S5-10.
RDC 55 - Agência Nacional de Vigilância Sanitária. Registro de Produtos Biológicos | Bases Legais e Guias - Coletânea -459p.: il.; graf.; tab. ISBN.
Ferreira LM, Filho ST, Costa RO, Godoy A, Steiner D, Fleissig L, et al. Eficácia e tolerabilidade de uma nova toxina botulínica tipo A para tratamento estético de rugas faciais dinâmicas: estudo multicêntrico prospectivo de fase III. Surgical & Cosmetic Dermatology 2009;1(2): 58-63.
Filho ST, Bagatin E, Monteiro EO, Pinheiro MVB, Hassun KM. Eficácia e segurança da neurotoxina botulínica tipo A* no tratamento de linhas de expressão glabelares. RBM rev. bras. med;65(n.esp):28-33, out. 2008.
Gracies JM, Simpson DM. Botulinum toxin therapy. Neurologist 6:98,2000.

Responsible Party: Azidus Brasil
ClinicalTrials.gov Identifier: NCT01180348     History of Changes
Other Study ID Numbers: TOXBER0610 
Study First Received: August 10, 2010
Last Updated: March 3, 2016
Health Authority: Brazil: National Health Surveillance Agency
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: The study data will be maked available after journal's approbation. The manuscript contained all of data it has been submitted.

Keywords provided by Azidus Brasil:
Wrinkles, glabellar, facial.

Additional relevant MeSH terms:
Botulinum Toxins
OnabotulinumtoxinA
Botulinum Toxins, Type A
AbobotulinumtoxinA
IncobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on July 25, 2016