We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Field of Effects of Two Commercial Preparations of Botulinum Toxin Type A

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00989768
First Posted: October 6, 2009
Last Update Posted: June 2, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Brazilan Center for Studies in Dermatology
Results First Submitted: October 28, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, 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
  Hide Participant Flow

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
  Hide Baseline Characteristics

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
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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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

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

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

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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.


  More Information
  Hide More Information

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: Juliana de Souza
Organization: Brazilian Center for Studies in Dermatology
phone: +55 51 3026 2633
e-mail: pesquisa@cebd.org.br



Responsible Party: Doris Hexsel, CBED
ClinicalTrials.gov Identifier: NCT00989768     History of Changes
Other Study ID Numbers: 01-CBED06b
First Submitted: October 5, 2009
First Posted: October 6, 2009
Results First Submitted: October 28, 2009
Results First Posted: April 27, 2010
Last Update Posted: June 2, 2010