A Phase 4 interventional study of botulinum toxin Type A in Skin Aging, sponsored by Allergan. Completed at 2 sites in United States. Open to female participants aged 35 Years to 55 Years. Per ClinicalTrials.gov, last updated 2019-01-29.
Sponsored by Allergan · Phase 4, Interventional, and Treatment
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)
Allergan is the lead sponsor of 499 studies on the registry; none are open to participants now.
Of its 91 completed or terminated interventional studies of FDA-regulated products, 89 (98%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
botulinum toxin Type A 20U
Biological: botulinum toxin Type A
20U, up to two injections administered intramuscularly into the glabella (2 in each side of the corrugators and 1 in the procerus)
Also known as: BOTOX®
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.
Time frame: 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.
Time frame: 14 Days
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Day 14
| Milestone | Botulinum Toxin Type A 20U |
|---|---|
| Started | 45 |
| Completed | 45 |
| Not completed | 0 |
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.
| Number of Days | Botulinum Toxin Type A 20U |
|---|---|
| The First Visit Onset of Efficacy as Measured by Physician Assessment | 2.2 ± 0.55 |
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.
| Number of Days | Botulinum Toxin Type A 20U |
|---|---|
| The First Visit Onset of Efficacy as Measured by Subject Assessment | 1.84 ± 1.01 |
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.
| Scores on a Scale | Botulinum Toxin Type A 20U |
|---|---|
| 1st Diary Week | 1.73 ± 0.65 |
| 2nd Diary Week | 2.64 ± 0.57 |
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.
| Scores on a Scale | Botulinum Toxin Type A 20U |
|---|---|
| Baseline | 32.97 ± 19.91 |
| Change from Baseline at Day 14 | 38.55 ± 28.20 |
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.
| Percentage of patients | Botulinum Toxin Type A 20U |
|---|---|
| Baseline Looking Younger | 22.2 |
| Baseline Looking Current Age | 40.0 |
| Baseline Looking Older | 37.8 |
| Day 14 Looking Younger | 42.2 |
| Day 14 Looking Current Age | 44.4 |
| Day 14 Looking Older | 13.3 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Botulinum Toxin Type A 20U | — | 0/45 (0%) | 0/45 (0%) |
| Age, Continuous(years) | Botulinum Toxin Type A 20U |
|---|---|
| Median | 43.5 (35.1 to 56.6) |
| Sex: Female, Male(Participants) | Botulinum Toxin Type A 20U |
|---|---|
| Female | 45 |
| Male | 0 |
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Allergan