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Comparison of Two Botulinum Toxins Type A on Forehead Wrinkles

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Galderma
ClinicalTrials.gov Identifier:
NCT01014871
First received: November 16, 2009
Last updated: April 17, 2012
Last verified: April 2012
History of Changes
Results First Received: August 12, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Wrinkles
Interventions: Drug: Botulinum Toxin Type A - Azzalure
Drug: Botulinum Toxin Type A - Vistabel

  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: patients from private practice - Recruitment period: First Patient In = 13 July 2009 Last Patient In = 09 November 2009 - Type of location: hospital

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Vistabel/Azzalure

at Baseline:

  • 1 injection of 20 units of Azzalure (2 points of 10 units) in 1 side of the forehead
  • 1 injection of 8 Speywood units of Vistabel (2 points of 4 Speywood units) in the other side of the forehead

Participant Flow:   Overall Study
    Vistabel/Azzalure  
STARTED     30  
COMPLETED     30  
NOT COMPLETED     0  



  Baseline Characteristics
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Reporting Groups
  Description
Vistabel/Azzalure

at Baseline:

  • 1 injection of 20 units of Azzalure (2 points of 10 units) in 1 side of the forehead
  • 1 injection of 8 Speywood units of Vistabel (2 points of 4 Speywood units) in the other side of the forehead

Baseline Measures
    Vistabel/Azzalure  
Number of Participants  
[units: participants]
 		  30  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     30  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation 		  46.4  ± 8.3  
Gender  
[units: participants]
 		 
Female     30  
Male     0  
Region of Enrollment  
[units: participants]
 		 
Germany     30  



  Outcome Measures

1.  Primary:   Severity of the Forehead Wrinkles by the Evaluator at Maximum Contraction and at Rest Using the Forehead Wrinkles Severity Scale (0 to 3) at Each Study Visit and for Each Side of the Forehead   [ Time Frame: 5 months : Baseline, Days 1, 2, 3, 7, 10, 14, 30, Months 4 and 5 ]
  Show Outcome Measure 1


  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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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
No text entered.  


Results Point of Contact:  
Name/Title: Florence Paliargues / CPM
Organization: Galderma
phone: +33492952957
e-mail: florence.paliargues@galderma.com


No publications provided


Responsible Party: Galderma
ClinicalTrials.gov Identifier: NCT01014871     History of Changes
Other Study ID Numbers: RD.03.SPR.29081
Study First Received: November 16, 2009
Results First Received: August 12, 2011
Last Updated: April 17, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices