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Long-Term Patient Satisfaction of Facial Aesthetic Treatment With BOTOX®

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.
 
ClinicalTrials.gov Identifier: NCT01608672
Recruitment Status : Completed
First Posted : May 31, 2012
Results First Posted : December 23, 2013
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Cross-Sectional
Condition Glabellar Lines
Intervention Biological: botulinum toxin Type A
Enrollment 207
Recruitment Details  
Pre-assignment Details Eligible patients were identified by retrospective chart review. Demographic and Outcome Measure data were collected at a study visit on Day 1 (approximately 4-28 weeks following last treatment) for patients who received treatment with BOTOX® for ≥5 years. Adverse Event data was collected by retrospective chart review.
Arm/Group Title All Participants
Hide Arm/Group Description Botulinum toxin Type A (BOTOX®) treatment to glabellar lines as prescribed by the Investigator over a period of at least 5 years.
Period Title: Overall Study
Started 207
Completed 207
Not Completed 0
Arm/Group Title All Participants
Hide Arm/Group Description Botulinum toxin Type A (BOTOX®) treatment to glabellar lines as prescribed by the Investigator over a period of at least 5 years.
Overall Number of Baseline Participants 207
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 207 participants
55.6  (10.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 207 participants
Female
194
  93.7%
Male
13
   6.3%
1.Primary Outcome
Title Percentage of Participants Mostly or Very Satisfied With Their Glabellar Lines on the Facial Line Satisfaction Questionnaire (FLSQ)
Hide Description Participants assessed their overall satisfaction with their glabellar lines by answering FLSQ Question 5: "How satisfied are you with the effect your treatment had on your facial lines?" using a 5-point scale where: -2=very dissatisfied, -1=mostly dissatisfied, 0=neither dissatisfied nor satisfied, 1=mostly satisfied and 2=very satisfied. The percentage of participants mostly or very satisfied is reported.
Time Frame Study Day 1 (approximately 4-28 weeks following last treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol population included all enrolled participants who met eligibility criteria with data available for analysis.
Arm/Group Title All Participants
Hide Arm/Group Description:
Botulinum toxin Type A (BOTOX®) treatment to glabellar lines as prescribed by the Investigator over a period of at least 5 years.
Overall Number of Participants Analyzed 194
Measure Type: Number
Unit of Measure: Percentage of participants
92.3
2.Secondary Outcome
Title Percentage of Participants Mostly or Very Satisfied With Effectiveness of ≥ 5 Years BOTOX® Treatments Using the Patient Questionnaire
Hide Description Participants rated their overall satisfaction with BOTOX® treatment by answering the question on the Patient Reported Overall Satisfaction of Effectiveness Questionnaire: "You have received BOTOX® facial aesthetic treatment(s) for at least 5 years. How satisfied overall are you with the effect of BOTOX®?" using the following possible answers: Very Dissatisfied, Mostly Dissatisfied, Neither Satisfied or Dissatisfied, Mostly Satisfied or Very Satisfied. The percentage of participants who answered Mostly Satisfied or Very Satisfied is reported.
Time Frame Study Day 1 (approximately 4-28 weeks following last treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol population included all enrolled participants who met eligibility criteria with data available for analysis.
Arm/Group Title All Participants
Hide Arm/Group Description:
Botulinum toxin Type A (BOTOX®) treatment to glabellar lines as prescribed by the Investigator over a period of at least 5 years.
Overall Number of Participants Analyzed 194
Measure Type: Number
Unit of Measure: Percentage of participants
95.8
3.Secondary Outcome
Title Percentage of Participants Where Physician Was Mostly or Very Satisfied With Effectiveness of ≥ 5 Years BOTOX® Treatments Using the Physician Questionnaire
Hide Description Physicians rated their overall satisfaction with BOTOX® treatment by answering the question on the Physician Reported Overall Satisfaction of Effectiveness Questionnaire: "You have treated this patient with BOTOX® facial aesthetic treatment(s) for at least 5 years. How satisfied overall are you with the effect of BOTOX®?" using the following possible answers: Very Dissatisfied, Mostly Dissatisfied, Neither Satisfied or Dissatisfied, Mostly Satisfied or Very Satisfied. The percentage of participants where the physician answered Mostly Satisfied or Very Satisfied is reported.
Time Frame Study Day 1 (approximately 4-28 weeks following last treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol population included all enrolled participants who met eligibility criteria with data available for analysis.
Arm/Group Title All Participants
Hide Arm/Group Description:
Botulinum toxin Type A (BOTOX®) treatment to glabellar lines as prescribed by the Investigator over a period of at least 5 years.
Overall Number of Participants Analyzed 194
Measure Type: Number
Unit of Measure: Percentage of participants
98.0
Time Frame The collection period was up to 17 years.
Adverse Event Reporting Description Adverse Event data was collected by retrospective chart review. Only treatment related adverse events were reported.
 
Arm/Group Title All Participants
Hide Arm/Group Description Botulinum toxin Type A (BOTOX®) treatment to glabellar lines as prescribed by the Investigator over a period of at least 5 years.
All-Cause Mortality
All Participants
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
All Participants
Affected / at Risk (%)
Total   0/207 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
All Participants
Affected / at Risk (%)
Total   23/207 (11.11%) 
Nervous system disorders   
Facial paresis  1 [1]  23/207 (11.11%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.1)
[1]
Includes lip and mouth asymmetry and brow ptosis.
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.
A 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 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Vice President Medical Affairs,
Organization: Allergan, Inc
Phone: 714-246-4500
EMail: clinicaltrials@allergan.com
Layout table for additonal information
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01608672    
Other Study ID Numbers: GMA-BTXC-11-004
First Submitted: May 29, 2012
First Posted: May 31, 2012
Results First Submitted: November 4, 2013
Results First Posted: December 23, 2013
Last Update Posted: April 16, 2019