A Phase 3 interventional study of botulinum toxin Type A and Normal Saline in Lateral Canthal Lines and Crow's Feet Lines, sponsored by Allergan. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-03-14.
Sponsored by Allergan (part of AbbVie) · Phase 3, Interventional, and Treatment
This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) compared with placebo in patients with moderate to severe crow's feet lines (lateral canthal lines).
Allergan is the lead sponsor of 505 studies on the registry; none are open to participants now.
Of its 93 completed or terminated interventional studies of FDA-regulated products, 91 (98%) have results posted.
First submitted before Allergan became part of AbbVie.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
-Moderate to severe Crow's Feet Lines.
Exclusion Criteria:
24U botulinum toxin Type A (BOTOX®) total dose injected into bilateral Crow's Feet Line areas on Day 1.
Biological: botulinum toxin Type A
Placebo (Normal Saline) injected into bilateral Crow's Feet Line areas on Day 1.
Drug: Normal Saline
botulinum toxin Type A (BOTOX®) injected into bilateral crow's feet line areas.
Also known as: BOTOX®
Normal Saline (placebo) injected into bilateral Crow's Feet Line areas.
Percentage of Subjects Achieving None or Mild on the Investigator's Assessment of the Severity of Crow's Feet Lines (CFL) at Maximum Smile Using the Facial Wrinkle Scale-Asian (FWS-A)
The Investigator assessed the severity of the subject's CFLs at maximum smile using the 4-point FWS-A where 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a score of none or mild at Day 30 is reported.
Time frame: Day 30
Percentage of Subjects With a ≥ 1-grade Improvement on the Investigator's Assessment of CFL Severity at Rest Using the 4-point FWS-A
The Investigator assessed the severity of the subject's CFLs at rest using the 4-point Facial Wrinkle Scale where 0=none, 1=mild, 2=moderate or 3=severe among subjects rated as at least mild at baseline by the Investigator. The percentages of subjects with at least a 1-grade improvement are noted.
Time frame: Day 30
Percentage of Subjects With a ≥ 1-grade Improvement on the Investigator's Assessment of CFL Severity at Maximum Smile on the 4-point FWS-A
The Investigator assessed the severity of the subject's CFLs at maximum smile using the 4-point Facial Wrinkle Scale where 0=none, 1=mild, 2=moderate or 3=severe. The percentages of subjects with at least a 1-grade improvement are noted.
Time frame: Day 30
Percentage of Subjects Reporting Their Global Change in Appearance as Very Much Improved or Much Improved Using the 7-point Subject's Global Assessment of Change in CFL (SGA-CFL)
Subjects assessed their global change in appearance using the 7-point SGA-CFL scale where 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse. The percentage of subjects reporting very much improved or much improved are noted.
Time frame: Day 30
Percentage of Subjects Assessing Their Age-related Facial Appearance as Looking Younger on the Self-Perception of Age (SPA) Questionnaire
Subjects assessed their age-related appearance according to the following on the SPA questionnaire: look my current age, look younger, and look older when compared to their baseline assessment. The percentages of subjects who reported looking younger amongst subjects who rated themselves as looking their current age or older at baseline are noted.
Time frame: Baseline, Day 30
Percentage of Subjects Achieving None or Mild on the Subject's Assessment of the Severity of Crow's Feet Lines (CFL) at Maximum Smile Using the Facial Wrinkle Scale-Asian (FWS-A)
The subject assessed the severity of their CFLs at maximum smile using the 4-point FWS-A where 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a score of none or mild at Day 30 is reported.
Time frame: Day 30
| Milestone | Botulinum Toxin Type A | Placebo |
|---|---|---|
| Started | 316 | 101 |
| Completed | 311 | 99 |
| Not completed | 5 | 2 |
| Withdrew: Personal reasons | 1 | 1 |
| Withdrew: Lost to follow-up | 4 | 1 |
The Investigator assessed the severity of the subject's CFLs at maximum smile using the 4-point FWS-A where 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a score of none or mild at Day 30 is reported.
| Percentage of Subjects | Botulinum Toxin Type A | Placebo |
|---|---|---|
| Percentage of Subjects Achieving None or Mild on the Investigator's Assessment of the Severity of Crow's Feet Lines (CFL) at Maximum Smile Using the Facial Wrinkle Scale-Asian (FWS-A) | 63.9 | 5.0 |
The Investigator assessed the severity of the subject's CFLs at rest using the 4-point Facial Wrinkle Scale where 0=none, 1=mild, 2=moderate or 3=severe among subjects rated as at least mild at baseline by the Investigator. The percentages of subjects with at least a 1-grade improvement are noted.
| Percentage of Subjects | Botulinum Toxin Type A | Placebo |
|---|---|---|
| Percentage of Subjects With a ≥ 1-grade Improvement on the Investigator's Assessment of CFL Severity at Rest Using the 4-point FWS-A | 60.1 | 5.4 |
The Investigator assessed the severity of the subject's CFLs at maximum smile using the 4-point Facial Wrinkle Scale where 0=none, 1=mild, 2=moderate or 3=severe. The percentages of subjects with at least a 1-grade improvement are noted.
| Percentage of Subjects | Botulinum Toxin Type A | Placebo |
|---|---|---|
| Percentage of Subjects With a ≥ 1-grade Improvement on the Investigator's Assessment of CFL Severity at Maximum Smile on the 4-point FWS-A | 85.1 | 12.9 |
Subjects assessed their global change in appearance using the 7-point SGA-CFL scale where 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse. The percentage of subjects reporting very much improved or much improved are noted.
| Percentage of Subjects | Botulinum Toxin Type A | Placebo |
|---|---|---|
| Percentage of Subjects Reporting Their Global Change in Appearance as Very Much Improved or Much Improved Using the 7-point Subject's Global Assessment of Change in CFL (SGA-CFL) | 54.4 | 3.0 |
Subjects assessed their age-related appearance according to the following on the SPA questionnaire: look my current age, look younger, and look older when compared to their baseline assessment. The percentages of subjects who reported looking younger amongst subjects who rated themselves as looking their current age or older at baseline are noted.
| Percentage of Subjects | Botulinum Toxin Type A | Placebo |
|---|---|---|
| Percentage of Subjects Assessing Their Age-related Facial Appearance as Looking Younger on the Self-Perception of Age (SPA) Questionnaire | 53.9 | 14.7 |
The subject assessed the severity of their CFLs at maximum smile using the 4-point FWS-A where 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a score of none or mild at Day 30 is reported.
| Percentage of Subjects | Botulinum Toxin Type A | Placebo |
|---|---|---|
| Percentage of Subjects Achieving None or Mild on the Subject's Assessment of the Severity of Crow's Feet Lines (CFL) at Maximum Smile Using the Facial Wrinkle Scale-Asian (FWS-A) | 60.8 | 5.9 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Botulinum Toxin Type A | — | 0/316 (0%) | 0/316 (0%) |
| Placebo | — | 0/101 (0%) | 0/101 (0%) |
| Age, Continuous(Years) | Botulinum Toxin Type A | Placebo | Total |
|---|---|---|---|
| Mean | 46.3 ± 9.64 | 46.6 ± 9.39 | 46.4 ± 9.57 |
| Sex: Female, Male(Participants) | Botulinum Toxin Type A | Placebo | Total |
|---|---|---|---|
| Female | 273 | 87 | 360 |
| Male | 43 | 14 | 57 |
The record gives a start of Sep 2014, a primary completion of Feb 2015 and a completion of Jun 2015. It does not say whether these dates are actual or estimated.
Results were first posted in Mar 2016, 1 year 1 month after primary completion.
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This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Botulinum toxin type A