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:
Allergan
Information provided by (Responsible Party):
Allergan
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Brief Summary:
This is an observational study assessing patient satisfaction following at least 5 years of BOTOX® treatment for glabellar lines.
| Condition or disease | Intervention/treatment |
|---|---|
| Glabellar Lines | Biological: botulinum toxin Type A |
| Study Type : | Observational |
| Actual Enrollment : | 207 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Cross-Sectional |
| Actual Study Start Date : | April 1, 2012 |
| Actual Primary Completion Date : | December 31, 2012 |
| Actual Study Completion Date : | December 31, 2012 |
| Group/Cohort | Intervention/treatment |
|---|---|
|
All participants
Botulinum toxin Type A (BOTOX®) treatment to glabellar lines as prescribed by the Investigator over at least 5 years.
|
Biological: botulinum toxin Type A
botulinum toxin Type A (BOTOX®) treatment to glabellar lines as prescribed by the Investigator over at least 5 years.
Other Names:
|
Primary Outcome Measures :
- Percentage of Participants Mostly or Very Satisfied With Their Glabellar Lines on the Facial Line Satisfaction Questionnaire (FLSQ) [ Time Frame: Study Day 1 (approximately 4-28 weeks following last treatment) ]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.
Secondary Outcome Measures :
- Percentage of Participants Mostly or Very Satisfied With Effectiveness of ≥ 5 Years BOTOX® Treatments Using the Patient Questionnaire [ Time Frame: Study Day 1 (approximately 4-28 weeks following last treatment) ]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.
- Percentage of Participants Where Physician Was Mostly or Very Satisfied With Effectiveness of ≥ 5 Years BOTOX® Treatments Using the Physician Questionnaire [ Time Frame: Study Day 1 (approximately 4-28 weeks following last treatment) ]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.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Subjects treated for at least 5 years with BOTOX® for glabellar lines
Criteria
Inclusion Criteria:
- At least one BOTOX® treatment for facial wrinkles (glabellar lines) per calendar year for ≥5 years
Exclusion Criteria:
- Received botulinum toxin formulations other than BOTOX®
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01608672
Locations
| United States, Florida | |
| Coral Gables, Florida, United States | |
| Australia | |
| South Yarra, Australia | |
| Brazil | |
| Sao Paolo, Brazil | |
| Canada, Ontario | |
| Niagara Falls, Ontario, Canada | |
| France | |
| Cannes, France | |
Sponsors and Collaborators
Allergan
Investigators
| Study Director: | Medical Director | Allergan |
Publications:
| Responsible Party: | Allergan |
| ClinicalTrials.gov Identifier: | NCT01608672 |
| Other Study ID Numbers: |
GMA-BTXC-11-004 |
| First Posted: | May 31, 2012 Key Record Dates |
| Results First Posted: | December 23, 2013 |
| Last Update Posted: | April 16, 2019 |
| Last Verified: | April 2019 |
Additional relevant MeSH terms:
|
Botulinum Toxins Botulinum Toxins, Type A abobotulinumtoxinA Acetylcholine Release Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action |
Cholinergic Agents Neurotransmitter Agents Physiological Effects of Drugs Neuromuscular Agents Peripheral Nervous System Agents |