Randomized Study of Clinical Non-inferiority of Botulift Compared to Botox® in the Improvement of Wrinkles in the Facial Region.

This study has been completed.
Sponsor:
Collaborator:
Laboratório Químico Farmacêutico Bergamo Ltda.
Information provided by:
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier:
NCT01180348
First received: August 10, 2010
Last updated: February 22, 2013
Last verified: February 2013
  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 in the Glabellar Region Facial.
Drug: 30 U of botulinum toxin type A
Drug: Injection of botulinum toxin type A
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 L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:

Primary Outcome Measures:
  • Improvement of facial wrinkles in the glabellar region. [ Time Frame: 0 day ] [ Designated as safety issue: No ]
  • Improvement of facial wrinkles in the glabellar region. [ Time Frame: 3 days after treatment with botulinum toxin ] [ Designated as safety issue: No ]
  • Improvement of facial wrinkles in the glabellar region. [ Time Frame: 30 days after treatment with botulinum toxin ] [ Designated as safety issue: No ]
  • Improvement of facial wrinkles in the glabellar region. [ Time Frame: 60 days after treatment with botulinum toxin ] [ Designated as safety issue: No ]
  • Improvement of facial wrinkles in the glabellar region. [ Time Frame: 90 days after treatment with botulinum toxin ] [ Designated as safety issue: No ]
  • Improvement of facial wrinkles in the glabellar region. [ Time Frame: 120 days after treatment with botulinum toxin ] [ Designated as safety issue: No ]
  • Evaluate digital photographs obtained by the apparatus Apparatus Visia ® Digital Compexton Analysis (Canfield Imaging Systems, version 4.0.2). [ Time Frame: 0 days ] [ Designated as safety issue: No ]
  • Evaluate digital photographs obtained by the apparatus Apparatus Visia ® Digital Compexton Analysis (Canfield Imaging Systems, version 4.0.2). [ Time Frame: 3 days after treatment with botulinum toxin ] [ Designated as safety issue: No ]
  • Evaluate digital photographs obtained by the apparatus Apparatus Visia ® Digital Compexton Analysis (Canfield Imaging Systems, version 4.0.2). [ Time Frame: 30 days after treatment with botulinum toxin ] [ Designated as safety issue: No ]
  • Evaluate digital photographs obtained by the apparatus Apparatus Visia ® Digital Compexton Analysis (Canfield Imaging Systems, version 4.0.2). [ Time Frame: 60 days after treatment with botulinum toxin ] [ Designated as safety issue: No ]
  • Evaluate digital photographs obtained by the apparatus Apparatus Visia ® Digital Compexton Analysis (Canfield Imaging Systems, version 4.0.2). [ Time Frame: 90 days after treatment with botulinum toxin ] [ Designated as safety issue: No ]
  • Evaluate digital photographs obtained by the apparatus Apparatus Visia ® Digital Compexton Analysis (Canfield Imaging Systems, version 4.0.2). [ Time Frame: 120 days after treatment with botulinum toxin ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Registry of adverse reactions occurring during treatment. [ Time Frame: 0 day ] [ Designated as safety issue: Yes ]
  • Registry of adverse reactions occurring during treatment. [ Time Frame: 3 days after treatment with botulinum toxin ] [ Designated as safety issue: Yes ]
  • Registry of adverse reactions occurring during treatment. [ Time Frame: 30 days after treatment with botulinum toxin ] [ Designated as safety issue: Yes ]
  • Registry of adverse reactions occurring during treatment. [ Time Frame: 60 days after treatment with botulinum toxin ] [ Designated as safety issue: Yes ]
  • Registry of adverse reactions occurring during treatment. [ Time Frame: 90 days after treatment with botulinum toxin ] [ Designated as safety issue: Yes ]
  • Registry of adverse reactions occurring during treatment. [ Time Frame: 120 days after treatment with botulinum toxin ] [ Designated as safety issue: Yes ]
  • Overall patient satisfaction by completing an analytical scale of satisfaction. [ Time Frame: 0 day ] [ Designated as safety issue: No ]
  • Overall patient satisfaction by completing an analytical scale of satisfaction. [ Time Frame: 3 days after treatment with botulinum toxin ] [ Designated as safety issue: No ]
  • Overall patient satisfaction by completing an analytical scale of satisfaction. [ Time Frame: 30 days after treatment with botulinum toxin ] [ Designated as safety issue: No ]
  • Overall patient satisfaction by completing an analytical scale of satisfaction. [ Time Frame: 60 days after treatment with botulinum toxin ] [ Designated as safety issue: No ]
  • Overall patient satisfaction by completing an analytical scale of satisfaction. [ Time Frame: 90 days after treatment with botulinum toxin ] [ Designated as safety issue: No ]
  • Overall patient satisfaction by completing an analytical scale of satisfaction. [ Time Frame: 120 days after treatment with botulinum toxin ] [ Designated as safety issue: No ]

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
Botulinum toxin type A injection
Drug: 30 U of botulinum toxin type A
Intramuscular injection at three sites in the glabellar region, 2 in the corrugator muscle and one in the procerus muscle (10U per site).
Other Name: T (arm treaty with Botulif)
Active Comparator: Botox ®
Botulinum toxin type A injection
Drug: Injection of botulinum toxin type A
Intramuscular injection at three sites in the glabellar region, 2 in the corrugator muscle and one in the procerus muscle (10U per site)
Other Name: Co (arm treaty with Botox ®)

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
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
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
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

No publications provided

Responsible Party: Dr. Alexandre Frederico, L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier: NCT01180348     History of Changes
Other Study ID Numbers: TOXBER0610
Study First Received: August 10, 2010
Last Updated: February 22, 2013
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:
Wrinkles, glabellar, facial.

Additional relevant MeSH terms:
Facies
Disease Attributes
Pathologic Processes
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 30, 2014