Trial Outcomes & Findings for BOTOX® in the Treatment of Crow's Feet Lines in Japan (NCT NCT01797081)
NCT ID: NCT01797081
Last Updated: 2019-04-16
Results Overview
The Investigator assessed the severity of the patient's Crow's Feet lines at maximum smile using the 4-point Facial Wrinkle Scale where 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a score of none or mild at Day 30 is reported.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
300 participants
Primary outcome timeframe
Day 30
Results posted on
2019-04-16
Participant Flow
Participant milestones
| Measure |
Botulinum Toxin Type A (24U)
24 units (U) botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
|
Botulinum Toxin Type A (12U)
12U botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
|
Placebo/Botulinum Toxin Type A (24 U)
Placebo (normal saline) one treatment injected into bilateral Crow's Feet Line areas on Day 1 and subsequent treatments if applicable until day 180. Botulinum toxin Type A (24 U) injected into bilateral Crow's Feet Line areas at any additional treatments from day 180 onward. Based on retreatment criteria participants were eligible for up to 5 treatment cycles (2 Placebo + 3 botulinum toxin type A).
|
Placebo/Botulinum Toxin Type A (12 U)
Placebo (normal saline) one treatment injected into bilateral Crow's Feet Line areas on Day 1 and subsequent treatments if applicable until day 180. Botulinum toxin Type A (12 U) injected into bilateral Crow's Feet Line areas at any additional treatments from day 180 onward. Based on retreatment criteria participants were eligible for up to 5 treatment cycles (2 Placebo + 3 botulinum toxin type A).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
104
|
99
|
48
|
49
|
|
Overall Study
COMPLETED
|
90
|
95
|
43
|
40
|
|
Overall Study
NOT COMPLETED
|
14
|
4
|
5
|
9
|
Reasons for withdrawal
| Measure |
Botulinum Toxin Type A (24U)
24 units (U) botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
|
Botulinum Toxin Type A (12U)
12U botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
|
Placebo/Botulinum Toxin Type A (24 U)
Placebo (normal saline) one treatment injected into bilateral Crow's Feet Line areas on Day 1 and subsequent treatments if applicable until day 180. Botulinum toxin Type A (24 U) injected into bilateral Crow's Feet Line areas at any additional treatments from day 180 onward. Based on retreatment criteria participants were eligible for up to 5 treatment cycles (2 Placebo + 3 botulinum toxin type A).
|
Placebo/Botulinum Toxin Type A (12 U)
Placebo (normal saline) one treatment injected into bilateral Crow's Feet Line areas on Day 1 and subsequent treatments if applicable until day 180. Botulinum toxin Type A (12 U) injected into bilateral Crow's Feet Line areas at any additional treatments from day 180 onward. Based on retreatment criteria participants were eligible for up to 5 treatment cycles (2 Placebo + 3 botulinum toxin type A).
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
1
|
0
|
|
Overall Study
Pregnancy
|
1
|
0
|
0
|
0
|
|
Overall Study
Personal Reasons
|
12
|
4
|
4
|
8
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
1
|
Baseline Characteristics
BOTOX® in the Treatment of Crow's Feet Lines in Japan
Baseline characteristics by cohort
| Measure |
Botulinum Toxin Type A (24U)
n=104 Participants
24 units (U) botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
|
Botulinum Toxin Type A (12U)
n=99 Participants
12U botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
|
Placebo/Botulinum Toxin Type A (24 U)
n=48 Participants
Placebo (normal saline) one treatment injected into bilateral Crow's Feet Line areas on Day 1 and subsequent treatments if applicable until day 180. Botulinum toxin Type A (24 U) injected into bilateral Crow's Feet Line areas at any additional treatments from day 180 onward. Based on retreatment criteria participants were eligible for up to 5 treatment cycles (2 Placebo + 3 botulinum toxin type A).
|
Placebo/Botulinum Toxin Type A (12 U)
n=49 Participants
Placebo (normal saline) one treatment injected into bilateral Crow's Feet Line areas on Day 1 and subsequent treatments if applicable until day 180. Botulinum toxin Type A (12 U) injected into bilateral Crow's Feet Line areas at any additional treatments from day 180 onward. Based on retreatment criteria participants were eligible for up to 5 treatment cycles (2 Placebo + 3 botulinum toxin type A).
|
Total
n=300 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
≤ 50 years
|
53 participants
n=5 Participants
|
58 participants
n=7 Participants
|
28 participants
n=5 Participants
|
30 participants
n=4 Participants
|
169 participants
n=21 Participants
|
|
Age, Customized
> 50 years
|
51 participants
n=5 Participants
|
41 participants
n=7 Participants
|
20 participants
n=5 Participants
|
19 participants
n=4 Participants
|
131 participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
84 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
224 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
76 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 30Population: Intent-to-treat population included all enrolled participants.
The Investigator assessed the severity of the patient's Crow's Feet lines at maximum smile using the 4-point Facial Wrinkle Scale where 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a score of none or mild at Day 30 is reported.
Outcome measures
| Measure |
Botulinum Toxin Type A (24U)
n=104 Participants
24 units (U) botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
|
Botulinum Toxin Type A (12U)
n=99 Participants
12U botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
|
Placebo
n=97 Participants
Placebo (normal saline) one treatment injected into bilateral Crow's Feet Line areas on Day 1 and subsequent treatments if applicable until day 180.
|
|---|---|---|---|
|
Percentage of Participants 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)
|
68.3 percentage of participants
|
56.6 percentage of participants
|
8.2 percentage of participants
|
SECONDARY outcome
Timeframe: Day 30Population: Participants from the Intent-to-treat population, all enrolled participants, with data available for analysis.
The Investigator assessed the severity of the participant's Crow's Feet Lines at rest using the 4-point Facial Wrinkle Scale where 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a ≥1-grade improvement from Baseline at Day 30 is reported.
Outcome measures
| Measure |
Botulinum Toxin Type A (24U)
n=99 Participants
24 units (U) botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
|
Botulinum Toxin Type A (12U)
n=94 Participants
12U botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
|
Placebo
n=81 Participants
Placebo (normal saline) one treatment injected into bilateral Crow's Feet Line areas on Day 1 and subsequent treatments if applicable until day 180.
|
|---|---|---|---|
|
Percentage of Participants Achieving a ≥1-Grade Improvement From Baseline on the Investigator's Assessment of the Severity of CFL at Rest Using the FWS-A
|
61.6 percentage of participants
|
43.6 percentage of participants
|
17.3 percentage of participants
|
SECONDARY outcome
Timeframe: Day 30Population: Intent-to-treat population included all enrolled participants.
Participants rated the change in their Crow's Feet Lines using the Subject's Global Assessment of Change in Crow's Feet Lines (SGA-CFL) 7-point scale where 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse or 7=very much worse. The percentage of participants who reported Much Improved or Very Much Improved at Day 30 is reported.
Outcome measures
| Measure |
Botulinum Toxin Type A (24U)
n=104 Participants
24 units (U) botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
|
Botulinum Toxin Type A (12U)
n=99 Participants
12U botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
|
Placebo
n=97 Participants
Placebo (normal saline) one treatment injected into bilateral Crow's Feet Line areas on Day 1 and subsequent treatments if applicable until day 180.
|
|---|---|---|---|
|
Percentage of Participants Much Improved or Very Much Improved in the Subject's Assessment of Appearance of CFL as Measured by the Global Assessment of Change in Crow's Feet Lines
|
49.0 percentage of participants
|
39.4 percentage of participants
|
1.0 percentage of participants
|
SECONDARY outcome
Timeframe: Day 30Population: Intent-to-treat population included all enrolled participants. Only those participants who rated themselves as looking their current age or older at Baseline were included in the analyses.
Participants were considered to judge themselves as looking younger if the category change was from "look my current age" at Baseline to "look younger" at Day 30 or from "look older" at Baseline to "look my current age/younger" at Day 30.
Outcome measures
| Measure |
Botulinum Toxin Type A (24U)
n=100 Participants
24 units (U) botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
|
Botulinum Toxin Type A (12U)
n=95 Participants
12U botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
|
Placebo
n=92 Participants
Placebo (normal saline) one treatment injected into bilateral Crow's Feet Line areas on Day 1 and subsequent treatments if applicable until day 180.
|
|---|---|---|---|
|
Percentage of Participants Who Rate Themselves in a Younger Self-Perception of Age Category Than at Baseline
|
32.0 percentage of participants
|
30.5 percentage of participants
|
7.6 percentage of participants
|
Adverse Events
Botulinum Toxin Type A (24U)
Serious events: 3 serious events
Other events: 23 other events
Deaths: 0 deaths
Botulinum Toxin Type A (12U)
Serious events: 2 serious events
Other events: 39 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Botulinum Toxin Type A (24U)
n=151 participants at risk
24 units (U) botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
|
Botulinum Toxin Type A (12U)
n=143 participants at risk
12U botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
|
Placebo
n=97 participants at risk
Placebo (normal saline) one treatment injected into bilateral Crow's Feet Line areas on Day 1 and subsequent treatments if applicable until day 180.
|
|---|---|---|---|
|
Nervous system disorders
Cerebral infarction
|
0.66%
1/151
Adverse events that occurred during the BOTOX cycles of the placebo/BOTOX 24U and placebo/BOTOX 12U participants are included in the corresponding BOTOX groups.
|
0.00%
0/143
Adverse events that occurred during the BOTOX cycles of the placebo/BOTOX 24U and placebo/BOTOX 12U participants are included in the corresponding BOTOX groups.
|
0.00%
0/97
Adverse events that occurred during the BOTOX cycles of the placebo/BOTOX 24U and placebo/BOTOX 12U participants are included in the corresponding BOTOX groups.
|
|
Infections and infestations
Diverticulitis
|
0.66%
1/151
Adverse events that occurred during the BOTOX cycles of the placebo/BOTOX 24U and placebo/BOTOX 12U participants are included in the corresponding BOTOX groups.
|
0.00%
0/143
Adverse events that occurred during the BOTOX cycles of the placebo/BOTOX 24U and placebo/BOTOX 12U participants are included in the corresponding BOTOX groups.
|
0.00%
0/97
Adverse events that occurred during the BOTOX cycles of the placebo/BOTOX 24U and placebo/BOTOX 12U participants are included in the corresponding BOTOX groups.
|
|
Infections and infestations
Herpes zoster
|
0.66%
1/151
Adverse events that occurred during the BOTOX cycles of the placebo/BOTOX 24U and placebo/BOTOX 12U participants are included in the corresponding BOTOX groups.
|
0.00%
0/143
Adverse events that occurred during the BOTOX cycles of the placebo/BOTOX 24U and placebo/BOTOX 12U participants are included in the corresponding BOTOX groups.
|
0.00%
0/97
Adverse events that occurred during the BOTOX cycles of the placebo/BOTOX 24U and placebo/BOTOX 12U participants are included in the corresponding BOTOX groups.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/151
Adverse events that occurred during the BOTOX cycles of the placebo/BOTOX 24U and placebo/BOTOX 12U participants are included in the corresponding BOTOX groups.
|
0.70%
1/143
Adverse events that occurred during the BOTOX cycles of the placebo/BOTOX 24U and placebo/BOTOX 12U participants are included in the corresponding BOTOX groups.
|
0.00%
0/97
Adverse events that occurred during the BOTOX cycles of the placebo/BOTOX 24U and placebo/BOTOX 12U participants are included in the corresponding BOTOX groups.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/151
Adverse events that occurred during the BOTOX cycles of the placebo/BOTOX 24U and placebo/BOTOX 12U participants are included in the corresponding BOTOX groups.
|
0.00%
0/143
Adverse events that occurred during the BOTOX cycles of the placebo/BOTOX 24U and placebo/BOTOX 12U participants are included in the corresponding BOTOX groups.
|
1.0%
1/97
Adverse events that occurred during the BOTOX cycles of the placebo/BOTOX 24U and placebo/BOTOX 12U participants are included in the corresponding BOTOX groups.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/151
Adverse events that occurred during the BOTOX cycles of the placebo/BOTOX 24U and placebo/BOTOX 12U participants are included in the corresponding BOTOX groups.
|
0.70%
1/143
Adverse events that occurred during the BOTOX cycles of the placebo/BOTOX 24U and placebo/BOTOX 12U participants are included in the corresponding BOTOX groups.
|
0.00%
0/97
Adverse events that occurred during the BOTOX cycles of the placebo/BOTOX 24U and placebo/BOTOX 12U participants are included in the corresponding BOTOX groups.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.00%
0/151
Adverse events that occurred during the BOTOX cycles of the placebo/BOTOX 24U and placebo/BOTOX 12U participants are included in the corresponding BOTOX groups.
|
0.00%
0/143
Adverse events that occurred during the BOTOX cycles of the placebo/BOTOX 24U and placebo/BOTOX 12U participants are included in the corresponding BOTOX groups.
|
1.0%
1/97
Adverse events that occurred during the BOTOX cycles of the placebo/BOTOX 24U and placebo/BOTOX 12U participants are included in the corresponding BOTOX groups.
|
Other adverse events
| Measure |
Botulinum Toxin Type A (24U)
n=151 participants at risk
24 units (U) botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
|
Botulinum Toxin Type A (12U)
n=143 participants at risk
12U botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
|
Placebo
n=97 participants at risk
Placebo (normal saline) one treatment injected into bilateral Crow's Feet Line areas on Day 1 and subsequent treatments if applicable until day 180.
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
15.2%
23/151
Adverse events that occurred during the BOTOX cycles of the placebo/BOTOX 24U and placebo/BOTOX 12U participants are included in the corresponding BOTOX groups.
|
27.3%
39/143
Adverse events that occurred during the BOTOX cycles of the placebo/BOTOX 24U and placebo/BOTOX 12U participants are included in the corresponding BOTOX groups.
|
5.2%
5/97
Adverse events that occurred during the BOTOX cycles of the placebo/BOTOX 24U and placebo/BOTOX 12U participants are included in the corresponding BOTOX groups.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER