Glabellar LinesNCT01608672
Long-Term Patient Satisfaction of Facial Aesthetic Treatment With BOTOX®
An observational study of Glabellar Lines, run by Allergan at 5 sites in 5 countries.
Trial summary
This is an observational study assessing patient satisfaction following at least 5 years of BOTOX® treatment for glabellar lines. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glabellar Lines
- What is being tested?
- botulinum toxin Type A
- How many people
- 207 participants
- Where
- 5 sitesin 5 countries
- Study dates
- 1 Apr 2012to 31 Dec 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects treated for at least 5 years with BOTOX® for glabellar lines
Who may be able to join
- At least one BOTOX® treatment for facial wrinkles (glabellar lines) per calendar year for ≥5 years
Who cannot join
- Received botulinum toxin formulations other than BOTOX®
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
About this study
This is an observational study assessing patient satisfaction following at least 5 years of BOTOX® treatment for glabellar lines.
- Conditions
- Glabellar Lines
- Being tested
- botulinum toxin Type A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
botulinum toxin Type ABiological
Also called BOTOX®, OnabotulinumtoxinA, BOTOX® Cosmetic, Vistabel®
botulinum toxin Type A (BOTOX®) treatment to glabellar lines as prescribed by the Investigator over at least 5 years.
| Study group | Role | What they receive |
|---|---|---|
| All participants | Botulinum toxin Type A (BOTOX®) treatment to glabellar lines as prescribed by the Investigator over at least 5 years. Receives: Biological: botulinum toxin Type A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Mostly or Very Satisfied With Their Glabellar Lines on the Facial Line Satisfaction Questionnaire (FLSQ)
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.
Measured: Study Day 1 (approximately 4-28 weeks following last treatment)
Secondary outcomes (2)
Percentage of Participants Mostly or Very Satisfied With Effectiveness of ≥ 5 Years BOTOX® Treatments Using the Patient Questionnaire
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.
Measured: Study Day 1 (approximately 4-28 weeks following last treatment)
Percentage of Participants Where Physician Was Mostly or Very Satisfied With Effectiveness of ≥ 5 Years BOTOX® Treatments Using the Physician Questionnaire
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.
Measured: Study Day 1 (approximately 4-28 weeks following last treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2012 (estimated)
- Study start1 Apr 2012
- Primary completion31 Dec 2012
- Study completion31 Dec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glabellar LinesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01608672
- Sponsor's protocol ID
- GMA-BTXC-11-004
- Status last verified
- Apr 2019
- First submitted
- 29 May 2012
- Last updated
- 16 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Trindade de Almeida A, Carruthers J, Cox SE, Goldman MP, Wheeler S, Gallagher CJ. Patient satisfaction and safety with aesthetic onabotulinumtoxinA after at least 5 years: a retrospective cross-sectional analysis of 4,402 glabellar treatments. Dermatol Surg. 2015 Jan;41 Suppl 1:S19-28. doi: 10.1097/DSS.0000000000000275.
PubMed 25548841
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Patient Satisfaction of Facial Aesthetic Treatment With BOTOX®
- ClinicalTrials.gov ID
- NCT01608672
- Acronym / sponsor ID
- GMA-BTXC-11-004
- Conditions
- Glabellar Lines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2012 (actual)
- Primary completion
- 31 Dec 2012 (actual)
- Study completion
- 31 Dec 2012 (actual)
- First posted
- 31 May 2012 (estimated)
- Results
- Posted 23 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an observational study assessing patient satisfaction following at least 5 years of BOTOX® treatment for glabellar lines.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants | – | Biological: botulinum toxin Type ABotulinum toxin Type A (BOTOX®) treatment to glabellar lines as prescribed by the Investigator over at least 5 years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects treated for at least 5 years with BOTOX® for glabellar lines
Key inclusion criteria (1 listed)
- At least one BOTOX® treatment for facial wrinkles (glabellar lines) per calendar year for ≥5 years
Key exclusion criteria (1 listed)
- Received botulinum toxin formulations other than BOTOX®
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| botulinum toxin Type AAlso: BOTOX®, OnabotulinumtoxinA, BOTOX® Cosmetic, Vistabel®botulinum toxin Type A (BOTOX®) treatment to glabellar lines as prescribed by the Investigator over at least 5 years. | Biological | All participants |
Primary outcome
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.
2 secondary outcomes
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)
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25548841Trindade de Almeida A, Carruthers J, Cox SE, Goldman MP, Wheeler S, Gallagher CJ. Patient satisfaction and safety with aesthetic onabotulinumtoxinA after at least 5 years: a retrospective cross-sectional analysis of 4,402 glabellar treatments. Dermatol Surg. 2015 Jan;41 Suppl 1:S19-28. doi: 10.1097/DSS.0000000000000275.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Allergan
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glabellar Lines, run by Allergan at 5 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Australia, Brazil, Canada, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01608672, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019.