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Clinical Trial to Assess Efficacy, Safety and Tolerability of Botulinum Toxin A (Xeomin®) in Treatment of Expression Wrinkles in the Upper Third of the Face (XEO-001/07)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biolab Sanus Farmaceutica
ClinicalTrials.gov Identifier:
NCT00986570
First received: September 29, 2009
Last updated: November 16, 2015
Last verified: November 2015
Results First Received: November 17, 2010  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Skin Aging
Intervention: Biological: Botulinum Toxin 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
Date of recruitment : 01-Sep-2009 to 09-Feb-2010 Location: Outpatient clinic; Cosmiatry, surgery and oncology unit, Department of Dermatology, UNIFESP, Sao Paulo, Brazil

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
Xeomin®

Botulinum Toxin A in IM injections single dose as follows:

24U in Orbicularis Oculorum (External area, 3 sites in each side) 20U in Glabella (5 sites) 8U in Frontal muscle (4 sites)


Participant Flow:   Overall Study
    Xeomin®
STARTED   121 
COMPLETED   114 
NOT COMPLETED   7 
Lost to Follow-up                6 
Potential bias for objective assessment                1 



  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
Xeomin®

Botulinum Toxin A in IM injections single dose as follows:

24U in Orbicularis Oculorum (External area, 3 sites in each side) 20U in Glabella (5 sites) 8U in Frontal muscle (4 sites)


Baseline Measures
   Xeomin® 
Overall Participants Analyzed 
[Units: Participants]
 121 
Age, Customized 
[Units: Participants]
 
Between 30 and 50 years   121 
Age 
[Units: Years]
Mean (Standard Deviation)
 42.52  (0.42) 
Gender 
[Units: Participants]
 
Female   121 
Male   0 
Region of Enrollment 
[Units: Participants]
 
Brazil   121 


  Outcome Measures

1.  Primary:   Treatment Success   [ Time Frame: Baseline (pre-treatment) and Visit 3 (Day 15) ]


  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
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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.


Results Point of Contact:  
Name/Title: Priscilla Padilha, MD
Organization: Biolab Sanus Farmacêutica Ltda.
phone: 55(11)35736335
e-mail: ppadilha@biolabfarma.com.br



Responsible Party: Biolab Sanus Farmaceutica
ClinicalTrials.gov Identifier: NCT00986570     History of Changes
Other Study ID Numbers: XEO-001/07
Study First Received: September 29, 2009
Results First Received: November 17, 2010
Last Updated: November 16, 2015
Health Authority: Brazil: National Health Surveillance Agency