Glabellar Frown LinesPhase 4NCT01391312
Patient Satisfaction Study of BOTOX® Cosmetic in the Treatment of Moderate to Severe Frown Lines
A Phase 4 study testing botulinum toxin Type A in people with Glabellar Frown Lines, run by Allergan at 1 site in United States.
Trial summary
This was a pilot study to observe patient satisfaction with BOTOX® Cosmetic treatment in glabellar rhytides (frown lines) using a new treatment satisfaction measure. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Glabellar Frown Lines
- What is being tested?
- botulinum toxin Type A
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Oct 2011
- Phase
- Phase 4
- 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate to severe glabellar wrinkles (frown lines)
Who cannot join
- Previous treatment with botulinum toxin therapy of any serotype
- Facial non-ablative resurfacing laser or light treatment, microdermabrasion, or superficial peels within 3 months
- Any facial cosmetic procedure with medium depth to deep facial chemical peels (e.g., trichloroacetic acid and phenol), mid-facial or periorbital laser skin resurfacing or permanent make-up within 6 months
- Mid-facial or periorbital treatment with non-permanent soft tissue fillers
- Subjects planning a facial cosmetic procedure or visible scars
- Previous cosmetic surgery to the upper face(e.g., prior periorbital surgery, facial lift, brow lift, eyelid lift or eyebrow surgery)
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- Diagnoses of Myasthenia Gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis
- History of facial nerve palsy
- A planned extended absence during the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of BOTOX® Cosmetic in the Treatment of Moderate to Severe Glabellar Lines - Establishing Patient Satisfaction
This was a pilot study to observe patient satisfaction with BOTOX® Cosmetic treatment in glabellar rhytides (frown lines) using a new treatment satisfaction measure.
- Conditions
- Glabellar Frown Lines
- Being tested
- botulinum toxin Type A, normal saline (placebo)
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® Cosmetic, Vistabel®, Vistabax®
botulinum toxin Type A 20U (total dose) injected into the glabellar region on Day 0.
normal saline (placebo)Drug
Normal saline (placebo) injected into the glabellar region on Day 0.
| Study group | Role | What they receive |
|---|---|---|
| botulinum toxin Type A | Active comparator | Botulinum toxin Type A 20U (total dose) injected into the glabellar region on Day 0. Receives: Biological: botulinum toxin Type A |
| placebo (Normal Saline) | Placebo comparator | Normal Saline (placebo) injected into the glabellar region on Day 0. Receives: Drug: normal saline (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Improvement in Subject Global Assessment of Change at Day 30
Subjects assessed the improvement of their glabellar lines (area between the eyebrows) by answering the question: Compared to before receiving the study treatment, How do you currently feel about the appearance of your glabellar lines? on a 7-point scale where 0=Very much improved, 1=Much improved, 2=Minimally improved, 3=No change, 4=Minimally worse, 5=Much worse, 6=Very much worse. Improvement was defined as responses: 0=Very much improved, 1=Much improved and 2=Minimally improved.
Measured: Day 30
Secondary outcomes (2)
Percentage of Facial Wrinkle Scale Responders at Maximum Attempted Muscle Contraction at Day 30
The Investigator rated the subject's severity of glabellar lines (between the eyebrows) at maximum attempted muscle contraction using the 4-point Facial Wrinkle scale where 0=None (Best), 1=Mild, 2=Moderate, 3=Severe (Worse) at day 30. Responders were defined as participants with a score of 0=None or 1=Mild.
Measured: Day 30
Percentage of Facial Wrinkle Scale Responders at Maximum Attempted Muscle Contraction at Day 60
The Investigator rated the subject's severity of glabellar lines (between the eyebrows) at maximum attempted muscle contraction using the 4-point Facial Wrinkle scale where 0=None (Best), 1=Mild, 2=Moderate, 3=Severe (Worse) at day 60. Responders were defined as participants with a score of 0=None or 1=Mild.
Measured: Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2011 (estimated)
- Study startJun 2011
- Primary completionOct 2011
- Study completionOct 2011
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.
- Other trials for Glabellar Frown 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 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
- NCT01391312
- Sponsor's protocol ID
- GMA-BTXC-11-001
- Status last verified
- Aug 2012
- First submitted
- 8 Jul 2011
- Last updated
- 25 Sep 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of BOTOX® Cosmetic in the Treatment of Moderate to Severe Glabellar Lines - Establishing Patient Satisfaction
- ClinicalTrials.gov ID
- NCT01391312
- Acronym / sponsor ID
- GMA-BTXC-11-001
- Conditions
- Glabellar Frown Lines
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 12 Jul 2011 (estimated)
- Results
- Posted 25 Sep 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a pilot study to observe patient satisfaction with BOTOX® Cosmetic treatment in glabellar rhytides (frown lines) using a new treatment satisfaction measure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| botulinum toxin Type A | Active comparator | Biological: botulinum toxin Type ABotulinum toxin Type A 20U (total dose) injected into the glabellar region on Day 0. |
| placebo (Normal Saline) | Placebo comparator | Drug: normal saline (placebo)Normal Saline (placebo) injected into the glabellar region on Day 0. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Moderate to severe glabellar wrinkles (frown lines)
Key exclusion criteria (9 listed)
- Previous treatment with botulinum toxin therapy of any serotype
- Facial non-ablative resurfacing laser or light treatment, microdermabrasion, or superficial peels within 3 months
- Any facial cosmetic procedure with medium depth to deep facial chemical peels (e.g., trichloroacetic acid and phenol), mid-facial or periorbital laser skin resurfacing or permanent make-up within 6 months
- Mid-facial or periorbital treatment with non-permanent soft tissue fillers
- Subjects planning a facial cosmetic procedure or visible scars
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® Cosmetic, Vistabel®, Vistabax®botulinum toxin Type A 20U (total dose) injected into the glabellar region on Day 0. | Biological | botulinum toxin Type A |
| normal saline (placebo)Normal saline (placebo) injected into the glabellar region on Day 0. | Drug | placebo (Normal Saline) |
Primary outcome
Percentage of Participants With Improvement in Subject Global Assessment of Change at Day 30
Time frame: Day 30
Subjects assessed the improvement of their glabellar lines (area between the eyebrows) by answering the question: Compared to before receiving the study treatment, How do you currently feel about the appearance of your glabellar lines? on a 7-point scale where 0=Very much improved, 1=Much improved, 2=Minimally improved, 3=No change, 4=Minimally worse, 5=Much worse, 6=Very much worse. Improvement was defined as responses: 0=Very much improved, 1=Much improved and 2=Minimally improved.
2 secondary outcomes
Percentage of Facial Wrinkle Scale Responders at Maximum Attempted Muscle Contraction at Day 30
Time frame: Day 30
Percentage of Facial Wrinkle Scale Responders at Maximum Attempted Muscle Contraction at Day 60
Time frame: Day 60
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing botulinum toxin Type A in people with Glabellar Frown Lines, run by Allergan at 1 site in United States.
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 9 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 25 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Sep 2012). 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 With Improvement in Subject Global Assessment of Change at Day 30 (time frame: Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Sep 2012.