Comparison of Two Commercial Preparations of Botulinum Toxin Type A

This study has been completed.
Sponsor:
Information provided by:
Brazilan Center for Studies in Dermatology
ClinicalTrials.gov Identifier:
NCT00959907
First received: April 23, 2009
Last updated: December 9, 2009
Last verified: November 2009
Results First Received: April 23, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Wrinkles in Frontal Area
Intervention: Drug: BOTULINUM TOXIN TYPE-A

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

Recruitment process: It is planned to recruit a total of 58 subjects at one single centre, Brazilian Center For Studies in Dermatology, in Porto Alegre, Brazil. The anticipated drop out rate is 10%.

Baseline evaluation: May 2005 to July 2007.


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
13 volunteers were excluded; (screen failure) Iodine allergy=2 Minor´s Test failure=6 Mild wrinkles=3 Inclusion criteria failure=2

Reporting Groups
  Description
BoNT A1(4U) Group 1: Botulinum toxin A (Dysport®) will be administered 4 units of Dysport®
BoNT-A2(2U) Group 2: Botulinum toxin A (Botox®) will be administered 2 units of Botox®

Participant Flow:   Overall Study
    BoNT A1(4U)     BoNT-A2(2U)  
STARTED     30     29  
COMPLETED     27     28  
NOT COMPLETED     3     1  
Protocol Violation                 0                 1  
Adverse Event                 1                 0  
Withdrawal by Subject                 2                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
BoNT A1(4U) Group 1: Botulinum toxin A (Dysport®) will be administered 4 units of Dysport®
BoNT-A2(2U) Group 2: Botulinum toxin A (Botox®) will be administered 2 units of Botox®
Total Total of all reporting groups

Baseline Measures
    BoNT A1(4U)     BoNT-A2(2U)     Total  
Number of Participants  
[units: participants]
  30     29     59  
Age  
[units: years]
Mean ± Standard Deviation
  44.77  ± 8.67     41.86  ± 11.98     42.88  ± 10.54  
Gender  
[units: participants]
     
Female     30     29     59  
Male     0     0     0  



  Outcome Measures
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1.  Primary:   Horizontal Action Halo Diameter at 28 Days   [ Time Frame: 28 days ]

2.  Primary:   ECMAP in m. Frontialis BoNT A1(4U) X BoNT A2 (2U)   [ Time Frame: 28 days ]

3.  Primary:   Horizontal Action Halo Diameter at 112 Days   [ Time Frame: 112 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The field of muscular effects of the studied toxins was objectively measured by EMG and it is not very precise. However, there is no more precise objective measurement to currently evaluate the field effects in muscles than EMG.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Débora Zechmeister do Prado
Organization: CBED
phone: 55 51 30262633
e-mail: cbed@cbed.org.br


No publications provided


Responsible Party: Doris Hexsel, CBED
ClinicalTrials.gov Identifier: NCT00959907     History of Changes
Other Study ID Numbers: 01-CBED06
Study First Received: April 23, 2009
Results First Received: April 23, 2009
Last Updated: December 9, 2009
Health Authority: Brazil: Ministry of Health