Skin AgingPhase 4NCT00856414
Patient Satisfaction With Treatment of BOTOX® Cosmetic for the Temporary Correction of Moderate to Severe Glabellar Lines
A Phase 4 study testing botulinum toxin Type A in people with Skin Aging, run by Allergan at 2 sites in United States.
Trial summary
This study evaluates the patient satisfaction and onset of effect following treatment with botulinum toxin Type A in the treatment of glabellar rhytids (frown lines) Read more about this study
- Who is it for?
- Ages 35 to 55 years, women only
- Conditions the study is for
- Skin Aging
- What is being tested?
- botulinum toxin Type A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2009to Apr 2009
- 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 35 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female subjects of any race, 35-55 years of age
- Moderate to severe glabellar wrinkles (lines between the eyebrows)
Who cannot join
- Previous botulinum toxin therapy
- Subjects who are pregnant, breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control
- Subjects planning a facial cosmetic procedure or visible scars
- Previous cosmetic surgery to the upper face
- Medical condition that may increase their risk of exposure to botulinum toxin including diagnosed Myasthenia Gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis, or any other disease that might interfere with neuromuscular function
- History of facial nerve palsy
- Allergy or sensitivity to any component of the study medication
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Livonia, Michigan
Study site
West Palm Beach, Florida
About this study
This study evaluates the patient satisfaction and onset of effect following treatment with botulinum toxin Type A in the treatment of glabellar rhytids (frown lines)
- Conditions
- Skin Aging
- 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®
20U, up to two injections administered intramuscularly into the glabella (2 in each side of the corrugators and 1 in the procerus)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | botulinum toxin Type A 20U Receives: Biological: botulinum toxin Type A |
What is being measured
The primary outcome is the main question the study is designed to answer.
The First Visit Onset of Efficacy as Measured by Physician Assessment
The first visit onset of efficacy as measured by physician assessment. Onset is determined by a yes/no answer to the question "Since injecting the patient, have you noticed any effect on the appearance of the patient's frown lines (lines between the eyebrows)?" at days 2, 3, 4, 7, and 14.
Measured: 14 Days
The First Visit Onset of Efficacy as Measured by Subject Assessment
The first visit onset of efficacy as measured by subject assessment. Onset is determined by a yes/no answer to the question "Since being injected, have you noticed any effect on the appearance of your frown lines (lines between the eyebrows)?" at days 2, 3, 4, 7, and 14.
Measured: 14 Days
Secondary outcomes (3)
Average Subject Assessment Score in Improvement of Appearance of Frown Lines
Average subject assessment score in improvement of appearance of frown lines (lines between the eyebrows) as measured by a 7-point scale (1=very much improved and 7=very much worse)on a daily basis. The average scores over the 1st diary week (1-7 days) and the 2nd diary week (8-14 days) are presented.
Measured: 14 Days
Change From Baseline in Patient Satisfaction as Measured by Facial Line Outcome (FLO) Questionnaire Score
Change from baseline in patient satisfaction as measured by FLO questionnaire comprised of 11 items that assess subject's perceptions about specific aspects of their facial lines for the previous 7 days. Each question is scored on a 11-point scale (0=not at all, 5=somewhat, 10=very much) and the sums are converted to the total FLO score. The minimum total FLO score is 0 (worst) and the maximum total FLO score is 100 (best). The total FLO score was calculated at baseline and Day 14. A positive number change from baseline indicates an improvement.
Measured: Baseline, Day 14
Percentage of Patients Reporting Self-Perception of Age (SPA)
Percentage of patients reporting their SPA. SPA is measured by a questionnaire. Patients were asked to compare their facial appearance to their current age. Response options were "Looking younger", "Looking current age", and "Looking older". Results for each response are presented for Baseline and Day 14.
Measured: Baseline, Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionApr 2009
- Study completionApr 2009
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 Skin AgingStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 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
- NCT00856414
- Sponsor's protocol ID
- MA-BTX-0806
- Status last verified
- Jan 2019
- First submitted
- 4 Mar 2009
- Last updated
- 29 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Beer KR, Boyd C, Patel RK, Bowen B, James SP, Brin MF. Rapid onset of response and patient-reported outcomes after onabotulinumtoxinA treatment of moderate-to-severe glabellar lines. J Drugs Dermatol. 2011 Jan;10(1):39-44.
PubMed 21197522
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Satisfaction With Treatment of BOTOX® Cosmetic for the Temporary Correction of Moderate to Severe Glabellar Lines
- ClinicalTrials.gov ID
- NCT00856414
- Acronym / sponsor ID
- MA-BTX-0806
- Conditions
- Skin Aging
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 5 Mar 2009 (estimated)
- Results
- Posted 12 Dec 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the patient satisfaction and onset of effect following treatment with botulinum toxin Type A in the treatment of glabellar rhytids (frown lines)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: botulinum toxin Type Abotulinum toxin Type A 20U |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Female subjects of any race, 35-55 years of age
- Moderate to severe glabellar wrinkles (lines between the eyebrows)
Key exclusion criteria (7 listed)
- Previous botulinum toxin therapy
- Subjects who are pregnant, breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control
- Subjects planning a facial cosmetic procedure or visible scars
- Previous cosmetic surgery to the upper face
- Medical condition that may increase their risk of exposure to botulinum toxin including diagnosed Myasthenia Gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis, or any other disease that might interfere with neuromuscular function
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®20U, up to two injections administered intramuscularly into the glabella (2 in each side of the corrugators and 1 in the procerus) | Biological | 1 |
Primary outcome
The First Visit Onset of Efficacy as Measured by Physician Assessment
Time frame: 14 Days
The first visit onset of efficacy as measured by physician assessment. Onset is determined by a yes/no answer to the question "Since injecting the patient, have you noticed any effect on the appearance of the patient's frown lines (lines between the eyebrows)?" at days 2, 3, 4, 7, and 14.
The First Visit Onset of Efficacy as Measured by Subject Assessment
Time frame: 14 Days
The first visit onset of efficacy as measured by subject assessment. Onset is determined by a yes/no answer to the question "Since being injected, have you noticed any effect on the appearance of your frown lines (lines between the eyebrows)?" at days 2, 3, 4, 7, and 14.
3 secondary outcomes
Average Subject Assessment Score in Improvement of Appearance of Frown Lines
Time frame: 14 Days
Change From Baseline in Patient Satisfaction as Measured by Facial Line Outcome (FLO) Questionnaire Score
Time frame: Baseline, Day 14
Percentage of Patients Reporting Self-Perception of Age (SPA)
Time frame: Baseline, Day 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21197522Beer KR, Boyd C, Patel RK, Bowen B, James SP, Brin MF. Rapid onset of response and patient-reported outcomes after onabotulinumtoxinA treatment of moderate-to-severe glabellar lines. J Drugs Dermatol. 2011 Jan;10(1):39-44.
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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
2 sites 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 Skin Aging, run by Allergan at 2 sites 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 2 inclusion and 7 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 29 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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 12 Dec 2011). 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?
The First Visit Onset of Efficacy as Measured by Physician Assessment (time frame: 14 Days). The study lists 2 primary outcomes in all. 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 NCT00856414, 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 29 Jan 2019.