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Trial record 60 of 719 for:    Botulinum Toxins, Type A

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

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ClinicalTrials.gov Identifier: NCT00989768
Recruitment Status : Completed
First Posted : October 6, 2009
Results First Posted : April 27, 2010
Last Update Posted : June 2, 2010
Sponsor:
Information provided by:
Brazilan Center for Studies in Dermatology

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®
Enrollment 29
Recruitment Details 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

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.

Arm/Group Title Dysport® 5U/ Botox® 2U
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 29 [1]
Completed 28
Not Completed 1
[1]
All patients received both treatments. They are their own controls
Arm/Group Title Dysport® 5U/ Botox® 2U
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 29
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants
<=18 years
0
   0.0%
Between 18 and 65 years
29
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants
Female
29
 100.0%
Male
0
   0.0%
1.Primary Outcome
Title Horizontal Action Halo Diameter at 28 Days
Hide Description The colorful complex formed by Minor’s test allows the visualization of the area covered by the effects of botulinum toxin on sweat glands, also known as action halos. The horizontal diameter at day 28 were expressed in centimeters and quantified by the software Mirror® (Canfield Scientific Inc., USA).
Time Frame 28 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dysport® 5U Botox® 2U
Hide Arm/Group Description:
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.
Two units of Botox® was administered to the other side of the frontal region.
Overall Number of Participants Analyzed 28 28
Mean (Standard Deviation)
Unit of Measure: centimeter
1.28  (0.26) 1.12  (0.31)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dysport® 5U, Botox® 2U
Comments In this study the null hypothesis was that BoNT-A1 had the same effect (halus)than the BoNT-A2.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.16
Parameter Dispersion
Type: Standard Deviation
Value: 0.36
Estimation Comments [Not Specified]
2.Primary Outcome
Title Horizontal Action Halo Diameter at 112 Days
Hide Description The colorful complex formed by Minor’s test allows the visualization of the area covered by the effects of botulinum toxin on sweat glands, also known as action halos. The horizontal diameter at day 112 were expressed in centimeters and quantified by the software Mirror® (Canfield Scientific Inc., USA).
Time Frame 112 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dysport® 5U Botox® 2U
Hide Arm/Group Description:
Subjects have received one injection of five units of botulinum toxin , called Dysport® on one side in the frontal region.
Two units of Botox® was administered to the other side of the frontal region.
Overall Number of Participants Analyzed 28 28
Mean (Standard Deviation)
Unit of Measure: centimeter
1.12  (0.26) 0.96  (0.29)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dysport® 5U, Botox® 2U
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title ECMAP in m. Frontialis
Hide Description The measurement of the ECMAP(Evoked Compound Muscle Action Potentials) used surface electrodes on the forehead and electrical stimulation of the facial nerve, according to standard neurophysiological procedures. The amplitude of the ECMAP in the m. frontalis on stimulation of the facial nerve was performed by an experienced neurologist. ECMAP was assessed by an electromyography (EMG) device (TECA Sapphire - TECA Corp., Pleasantville, NY).
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dysport® 5U Botox ® 2U
Hide Arm/Group Description:
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.
Two units of Botox® was administered to the other side of the frontal region.
Overall Number of Participants Analyzed 28 28
Mean (Standard Deviation)
Unit of Measure: microvolts
492.53  (290.70) 468.27  (263.31)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dysport® 5U, Botox ® 2U
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.61
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
4.Secondary Outcome
Title ECMAP in m. Frontialis
Hide Description The measurement of the ECMAP(Evoked Compound Muscle Action Potentials) used surface electrodes on the forehead and electrical stimulation of the facial nerve, according to standard neurophysiological procedures. The amplitude of the ECMAP in the m. frontalis on stimulation of the facial nerve was performed by an experienced neurologist. ECMAP was assessed by an electromyography (EMG) device (TECA Sapphire - TECA Corp., Pleasantville, NY).
Time Frame 112 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dysport® 5U Botox® 2U
Hide Arm/Group Description:
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.
Two units of Botox® was administered two units to the other side of frontal region
Overall Number of Participants Analyzed 28 28
Mean (Standard Deviation)
Unit of Measure: microVolts
482.63  (279.58) 539.16  (387.72)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dysport® 5U
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.36
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame 28 days and 112 days
Adverse Event Reporting Description Patients were evaluated for adverse events regarding the use of botulinum toxin, photograph and adverse event questionaire were performed.
 
Arm/Group Title Dysport® 5U/ Botox® 2U
Hide Arm/Group Description 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.
All-Cause Mortality
Dysport® 5U/ Botox® 2U
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Dysport® 5U/ Botox® 2U
Affected / at Risk (%) # Events
Total   0/29 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Dysport® 5U/ Botox® 2U
Affected / at Risk (%) # Events
Total   1/29 (3.45%)    
Respiratory, thoracic and mediastinal disorders   
flu   1/29 (3.45%)  1
Indicates events were collected by systematic assessment
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.
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
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