Trial Outcomes & Findings for Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Crow's Feet Lines and Frown Lines (NCT NCT01189760)
NCT ID: NCT01189760
Last Updated: 2019-04-16
Results Overview
The composite facial wrinkle scale assessment is based on both the Investigator and Subject Facial Wrinkle scales at Day 30. The Investigator assessed the severity of the patient's Crow's Feet Lines at maximum smile using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe and the patient assessed the severity of their Crow's Feet Lines at maximum smile using the same 4-point Facial Wrinkle Scale. A responder is defined as a participant with a ≥ 2-grade improvement from Baseline.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
917 participants
Primary outcome timeframe
Baseline, Day 30
Results posted on
2019-04-16
Participant Flow
Participant milestones
| Measure |
onabotulinumtoxinA 44U
44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
|
onabotulinumtoxinA 24U
24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
|
Placebo (Normal Saline)
Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
|
|---|---|---|---|
|
Overall Study
STARTED
|
305
|
306
|
306
|
|
Overall Study
COMPLETED
|
291
|
283
|
255
|
|
Overall Study
NOT COMPLETED
|
14
|
23
|
51
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Crow's Feet Lines and Frown Lines
Baseline characteristics by cohort
| Measure |
onabotulinumtoxinA 44U
n=305 Participants
44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
|
onabotulinumtoxinA 24U
n=306 Participants
24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
|
Placebo (Normal Saline)
n=306 Participants
Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
|
Total
n=917 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
<45 Years
|
87 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
276 Participants
n=4 Participants
|
|
Age, Customized
45 to 65 Years
|
204 Participants
n=5 Participants
|
200 Participants
n=7 Participants
|
194 Participants
n=5 Participants
|
598 Participants
n=4 Participants
|
|
Age, Customized
>65 Years
|
14 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
267 Participants
n=5 Participants
|
273 Participants
n=7 Participants
|
263 Participants
n=5 Participants
|
803 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
114 Participants
n=4 Participants
|
|
CFL Severity as Assessed by the Investigator
Moderate
|
109 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
337 Participants
n=4 Participants
|
|
CFL Severity as Assessed by the Investigator
Severe
|
196 Participants
n=5 Participants
|
191 Participants
n=7 Participants
|
193 Participants
n=5 Participants
|
580 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 30Population: Intent-to-treat population included all randomized participants. Participants with missing values are considered non-responders.
The composite facial wrinkle scale assessment is based on both the Investigator and Subject Facial Wrinkle scales at Day 30. The Investigator assessed the severity of the patient's Crow's Feet Lines at maximum smile using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe and the patient assessed the severity of their Crow's Feet Lines at maximum smile using the same 4-point Facial Wrinkle Scale. A responder is defined as a participant with a ≥ 2-grade improvement from Baseline.
Outcome measures
| Measure |
onabotulinumtoxinA 44U
n=305 Participants
44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
|
onabotulinumtoxinA 24U
n=306 Participants
24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
|
Placebo (Normal Saline)
n=306 Participants
Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
|
|---|---|---|---|
|
Percentage of Responders Based on Composite Facial Wrinkle Scale Assessment of Crow's Feet Line Severity at Maximum Smile
|
21.3 Percentage of participants
|
20.6 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 30Population: Intent-to-treat population included all randomized participants.
The Investigator assessed the severity of the patient's Crow's Feet lines at maximum smile using the 4-point Facial Wrinkle Scale: 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 |
onabotulinumtoxinA 44U
n=305 Participants
44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
|
onabotulinumtoxinA 24U
n=306 Participants
24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
|
Placebo (Normal Saline)
n=306 Participants
Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
|
|---|---|---|---|
|
Percentage of Participants Achieving a Grade of None or Mild at Maximum Smile Based on the Investigator Facial Wrinkle Scale Assessment of the Severity of Crow's Feet Lines
|
59.0 Percentage of participants
|
54.9 Percentage of participants
|
3.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Day 30Population: Intent-to-treat population included all randomized participants.
The Investigator assessed the severity of the patient's Crow's Feet Lines at maximum smile using the 4-point Facial Wrinkle Scale: 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 |
onabotulinumtoxinA 44U
n=305 Participants
44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
|
onabotulinumtoxinA 24U
n=306 Participants
24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
|
Placebo (Normal Saline)
n=306 Participants
Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
|
|---|---|---|---|
|
Percentage of Participants With a ≥ 1-Grade Improvement From Baseline by Investigator Facial Wrinkle Scale Assessment of the Severity of Crow's Feet Lines at Maximum Smile
|
87.9 Percentage of participants
|
78.1 Percentage of participants
|
10.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Day 30Population: Intent-to-treat population included all randomized participants. Only those participants who were rated at least mild at Baseline are included in the analyses.
The Investigator assessed the severity of the patient's Crow's Feet Lines at rest using the 4-point Facial Wrinkle Scale: 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 |
onabotulinumtoxinA 44U
n=293 Participants
44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
|
onabotulinumtoxinA 24U
n=297 Participants
24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
|
Placebo (Normal Saline)
n=298 Participants
Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
|
|---|---|---|---|
|
Percentage of Participants With a ≥ 1-Grade Improvement From Baseline by Investigator Facial Wrinkle Scale Assessment of the Severity of Crow's Feet Lines at Rest
|
75.1 Percentage of participants
|
61.3 Percentage of participants
|
13.4 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 30Population: Intent-to-treat population included all randomized participants.
Patients rated the change in their Crow's Feet Lines using the SGA-CFL 7-point scale: 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse or 7=very much worse at Day 30. Lower scores indicate improvement.
Outcome measures
| Measure |
onabotulinumtoxinA 44U
n=305 Participants
44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
|
onabotulinumtoxinA 24U
n=306 Participants
24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
|
Placebo (Normal Saline)
n=306 Participants
Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
|
|---|---|---|---|
|
Subject Global Assessment of Change in Crow's Feet Lines (SGA-CFL) Score
|
2.3 Score on a scale
Standard Deviation 0.96
|
2.5 Score on a scale
Standard Deviation 1.05
|
3.8 Score on a scale
Standard Deviation 0.54
|
SECONDARY outcome
Timeframe: Baseline, Day 30Population: Intent-to-treat population included all randomized participants. Only those participants who rated themselves as "look my current age" or "look older" at Baseline are 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 |
onabotulinumtoxinA 44U
n=265 Participants
44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
|
onabotulinumtoxinA 24U
n=265 Participants
24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
|
Placebo (Normal Saline)
n=263 Participants
Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
|
|---|---|---|---|
|
Percentage of Participants Who Judged Themselves in a Younger Self-Perception of Age Category Than at Baseline
|
50.6 Percentage of participants
|
33.6 Percentage of participants
|
9.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Day 30Population: Intent-to-treat population included all randomized participants. Only participants with a Baseline score ≥ 2 are included.
The percentage of FLO-11 Item #2 responders, defined as participants with a ≥ 2-point improvement in FLO-11 score from Baseline for FLO-11 Question #2: "When I look in the mirror, my facial lines make me look older than I want to look." The FLO-11 questionnaire is comprised of 11 items that assess the subject's perceptions about specific aspects of their facial lines for the previous 7 days. Each question is scored on an 11-point scale (0=not at all, 5=somewhat, 10=very much).
Outcome measures
| Measure |
onabotulinumtoxinA 44U
n=292 Participants
44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
|
onabotulinumtoxinA 24U
n=298 Participants
24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
|
Placebo (Normal Saline)
n=293 Participants
Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
|
|---|---|---|---|
|
Percentage of Participants With a ≥ 2-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 2 at Day 30
|
69.9 Percentage of participants
|
54.4 Percentage of participants
|
24.6 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Day 30Population: Intent-to-treat population included all randomized participants. Only participants with a Baseline score ≥ 2 are included.
The percentage of FLO-11 Item #5 responders, defined as participants with a ≥ 2-point improvement in FLO-11 score from Baseline for FLO-11 Question #5: "My facial lines make me look less attractive than I want to look." The FLO-11 questionnaire is comprised of 11 items that assess the subject's perceptions about specific aspects of their facial lines for the previous 7 days. Each question is scored on an 11-point scale (0=not at all, 5=somewhat, 10=very much).
Outcome measures
| Measure |
onabotulinumtoxinA 44U
n=287 Participants
44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
|
onabotulinumtoxinA 24U
n=282 Participants
24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
|
Placebo (Normal Saline)
n=280 Participants
Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
|
|---|---|---|---|
|
Percentage of Participants With a ≥ 2-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 5 at Day 30
|
61.7 Percentage of participants
|
48.6 Percentage of participants
|
18.6 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Day 30Population: Intent-to-treat population included all randomized participants. Only participants with a Baseline score ≥ 3 are included.
The percentage of FLO-11 Item #8 responders, defined as participants with a ≥ 3-point improvement in FLO-11 score from Baseline for FLO-11 Question #8: "My facial lines make me look tired." The FLO-11 questionnaire is comprised of 11 items that assess the subject's perceptions about specific aspects of their facial lines for the previous 7 days. Each question is scored on an 11-point scale (0=not at all, 5=somewhat, 10=very much).
Outcome measures
| Measure |
onabotulinumtoxinA 44U
n=284 Participants
44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
|
onabotulinumtoxinA 24U
n=280 Participants
24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
|
Placebo (Normal Saline)
n=282 Participants
Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
|
|---|---|---|---|
|
Percentage of Participants With a ≥ 3-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 8 at Day 30
|
58.1 Percentage of participants
|
40.7 Percentage of participants
|
14.9 Percentage of participants
|
Adverse Events
onabotulinumtoxinA 44U
Serious events: 5 serious events
Other events: 58 other events
Deaths: 0 deaths
onabotulinumtoxinA 24U
Serious events: 8 serious events
Other events: 51 other events
Deaths: 0 deaths
Placebo (Normal Saline)
Serious events: 6 serious events
Other events: 38 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
onabotulinumtoxinA 44U
n=305 participants at risk
44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
|
onabotulinumtoxinA 24U
n=306 participants at risk
24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
|
Placebo (Normal Saline)
n=306 participants at risk
Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
|
|---|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/305
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.33%
1/306
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.33%
1/306
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Endocrine disorders
Goitre
|
0.00%
0/305
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.33%
1/306
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/306
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
General disorders
Non-cardiac chest pain
|
0.33%
1/305
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/306
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/306
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/305
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/306
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.33%
1/306
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Infections and infestations
Pneumonia
|
0.33%
1/305
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/306
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.33%
1/306
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Infections and infestations
Herpes zoster
|
0.33%
1/305
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/306
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/306
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Infections and infestations
Breast cellulitis
|
0.00%
0/305
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.33%
1/306
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/306
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/305
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.33%
1/306
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/306
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/305
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/306
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.33%
1/306
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.33%
1/305
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.98%
3/306
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/306
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Nervous system disorders
Syncope
|
0.33%
1/305
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/306
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/306
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.00%
0/305
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.33%
1/306
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/306
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Reproductive system and breast disorders
Rectocele
|
0.00%
0/305
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/306
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.33%
1/306
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/305
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/306
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.33%
1/306
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
Other adverse events
| Measure |
onabotulinumtoxinA 44U
n=305 participants at risk
44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
|
onabotulinumtoxinA 24U
n=306 participants at risk
24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
|
Placebo (Normal Saline)
n=306 participants at risk
Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
7.9%
24/305
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
5.9%
18/306
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
4.9%
15/306
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Nervous system disorders
Headache
|
6.2%
19/305
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
4.6%
14/306
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
5.9%
18/306
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
General disorders
Injection site haematoma
|
4.9%
15/305
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
6.2%
19/306
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
1.6%
5/306
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
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