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 NCT01224015)
NCT ID: NCT01224015
Last Updated: 2014-02-25
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: 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
684 participants
Primary outcome timeframe
Day 30
Results posted on
2014-02-25
Participant Flow
Extension study for patients who participated in study 191622-099
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 up to 2 treatments during the study.
|
onabotulinumtoxinA 24U
24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
|
Placebo (Normal Saline)
Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
|
|---|---|---|---|
|
Overall Study
STARTED
|
361
|
227
|
96
|
|
Overall Study
COMPLETED
|
347
|
211
|
83
|
|
Overall Study
NOT COMPLETED
|
14
|
16
|
13
|
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=361 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 up to 2 treatments during the study.
|
onabotulinumtoxinA 24U
n=227 Participants
24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
|
Placebo (Normal Saline)
n=96 Participants
Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
|
Total
n=684 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
<45 Years
|
105 Participants
n=99 Participants
|
68 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
206 Participants
n=7 Participants
|
|
Age, Customized
45 to 65 Years
|
241 Participants
n=99 Participants
|
148 Participants
n=107 Participants
|
59 Participants
n=206 Participants
|
448 Participants
n=7 Participants
|
|
Age, Customized
>65 Years
|
15 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
30 Participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
315 Participants
n=99 Participants
|
203 Participants
n=107 Participants
|
80 Participants
n=206 Participants
|
598 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
86 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Day 30Population: Participants from the Intent-to-treat population, consisting of all randomized participants with data available for analysis.
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=349 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 up to 2 treatments during the study.
|
onabotulinumtoxinA 24U
n=223 Participants
24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
|
Placebo (Normal Saline)
n=95 Participants
Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
|
|---|---|---|---|
|
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
|
63.6 Percentage of participants
|
56.5 Percentage of participants
|
1.1 Percentage of participants
|
Adverse Events
onabotulinumtoxinA 44U
Serious events: 6 serious events
Other events: 44 other events
Deaths: 0 deaths
onabotulinumtoxinA 24U
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
Placebo (Normal Saline)
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
onabotulinumtoxinA 44U
n=349 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 up to 2 treatments during the study.
|
onabotulinumtoxinA 24U
n=223 participants at risk
24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
|
Placebo (Normal Saline)
n=95 participants at risk
Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
|
|---|---|---|---|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.29%
1/349
The safety population (all randomized participants who received study drug) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/223
The safety population (all randomized participants who received study drug) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/95
The safety population (all randomized participants who received study drug) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/349
The safety population (all randomized participants who received study drug) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/223
The safety population (all randomized participants who received study drug) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
1.1%
1/95
The safety population (all randomized participants who received study drug) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Infections and infestations
Gastrointestinal infection
|
0.29%
1/349
The safety population (all randomized participants who received study drug) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/223
The safety population (all randomized participants who received study drug) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/95
The safety population (all randomized participants who received study drug) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Infections and infestations
Infected bites
|
0.29%
1/349
The safety population (all randomized participants who received study drug) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/223
The safety population (all randomized participants who received study drug) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/95
The safety population (all randomized participants who received study drug) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/349
The safety population (all randomized participants who received study drug) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/223
The safety population (all randomized participants who received study drug) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
1.1%
1/95
The safety population (all randomized participants who received study drug) 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
|
0.29%
1/349
The safety population (all randomized participants who received study drug) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/223
The safety population (all randomized participants who received study drug) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/95
The safety population (all randomized participants who received study drug) 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%
0/349
The safety population (all randomized participants who received study drug) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.45%
1/223
The safety population (all randomized participants who received study drug) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/95
The safety population (all randomized participants who received study drug) 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)
Bowen's disease
|
0.29%
1/349
The safety population (all randomized participants who received study drug) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/223
The safety population (all randomized participants who received study drug) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/95
The safety population (all randomized participants who received study drug) 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)
Malignant melanoma in situ
|
0.29%
1/349
The safety population (all randomized participants who received study drug) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/223
The safety population (all randomized participants who received study drug) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/95
The safety population (all randomized participants who received study drug) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
Other adverse events
| Measure |
onabotulinumtoxinA 44U
n=349 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 up to 2 treatments during the study.
|
onabotulinumtoxinA 24U
n=223 participants at risk
24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
|
Placebo (Normal Saline)
n=95 participants at risk
Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
|
|---|---|---|---|
|
General disorders
Injection site haematoma
|
5.7%
20/349
The safety population (all randomized participants who received study drug) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
4.9%
11/223
The safety population (all randomized participants who received study drug) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
6.3%
6/95
The safety population (all randomized participants who received study drug) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Infections and infestations
Nasopharyngitis
|
1.7%
6/349
The safety population (all randomized participants who received study drug) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
4.0%
9/223
The safety population (all randomized participants who received study drug) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
6.3%
6/95
The safety population (all randomized participants who received study drug) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Nervous system disorders
Headache
|
5.2%
18/349
The safety population (all randomized participants who received study drug) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
1.3%
3/223
The safety population (all randomized participants who received study drug) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
3.2%
3/95
The safety population (all randomized participants who received study drug) 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