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Field of Effects 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:
NCT00989768
First received: October 5, 2009
Last updated: May 24, 2010
Last verified: October 2009
History of Changes
Results First Received: October 28, 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
Interventions: Drug: Botulinum Toxin Type A (Dysport®)
Drug: Botulinum Toxin Type A/Botox®
Drug: Botulinum Toxin Type A/Dysport®

  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
A total of 29 subjects was recruited at Brazilian Center For Studies in Dermatology, in Porto Alegre, Brazil. The anticipated drop out rate is 10%. Participants were their own control, because on one side of frontal region they have received 5U of botulinum toxin - Dysport and on other side 4U of botulinum toxin - Botox;

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

Minor’s test allows the visualization of the area covered by the effects of botulinum toxin on sweat glands also known as action halos.

Reporting Groups
  Description
Dysport® 5U/ Botox® 2U Botulinum toxin A (Dysport®) 5 U Subjects have received one injection of five units of botulinum toxin , called Dysport® on one side in the frontal region, that the other brand Botox® was administered two units to the other side of the frontal region.

Participant Flow:   Overall Study
    Dysport® 5U/ Botox® 2U  
STARTED     29 [1]
COMPLETED     28  
NOT COMPLETED     1  
[1] All patients received both treatments. They are their own controls



  Baseline Characteristics
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Reporting Groups
  Description
Dysport® 5U/ Botox® 2U Botulinum toxin A (Dysport®) 5 U Subjects have received one injection of five units of botulinum toxin , called Dysport® on one side in the frontal region, that the other brand Botox® was administered two units to the other side of the frontal region.

Baseline Measures
    Dysport® 5U/ Botox® 2U  
Number of Participants  
[units: participants]
 		  29  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     29  
>=65 years     0  
Gender  
[units: participants]
 		 
Female     29  
Male     0  



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

2.  Primary:   Horizontal Action Halo Diameter at 112 Days   [ Time Frame: 112 days ]
  Show Outcome Measure 2

3.  Secondary:   ECMAP in m. Frontialis   [ Time Frame: 28 days ]
  Show Outcome Measure 3

4.  Secondary:   ECMAP in m. Frontialis   [ Time Frame: 112 days ]
  Show Outcome Measure 4


  Serious Adverse Events
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  Other Adverse Events
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  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.


Limitations and Caveats
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.  


Results Point of Contact:  
Name/Title: Juliana de Souza
Organization: Brazilian Center for Studies in Dermatology
phone: +55 51 3026 2633
e-mail: pesquisa@cebd.org.br


No publications provided


Responsible Party: Doris Hexsel, CBED
ClinicalTrials.gov Identifier: NCT00989768     History of Changes
Other Study ID Numbers: 01-CBED06b
Study First Received: October 5, 2009
Results First Received: October 28, 2009
Last Updated: May 24, 2010
Health Authority: Brazil: Ministry of Health
Brazil: National Committee of Ethics in Research
Brazil: National Health Surveillance Agency