Trial Outcomes & Findings for BOTOX® in the Treatment of Upper Facial Lines in Japan (NCT NCT01797094)
NCT ID: NCT01797094
Last Updated: 2015-02-10
Results Overview
The Investigator assessed the severity of the participant'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
101 participants
Primary outcome timeframe
Day 30
Results posted on
2015-02-10
Participant Flow
Participant milestones
| Measure |
Botulinum Toxin Type A (44U)
44 units (U) botulinum toxin Type A (total dose) per treatment. 24U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
|
Botulinum Toxin Type A (32U)
32 units (U) botulinum toxin Type A (total dose) per treatment. 12U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
|
|---|---|---|
|
Overall Study
STARTED
|
48
|
53
|
|
Overall Study
COMPLETED
|
42
|
51
|
|
Overall Study
NOT COMPLETED
|
6
|
2
|
Reasons for withdrawal
| Measure |
Botulinum Toxin Type A (44U)
44 units (U) botulinum toxin Type A (total dose) per treatment. 24U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
|
Botulinum Toxin Type A (32U)
32 units (U) botulinum toxin Type A (total dose) per treatment. 12U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Personal Reasons
|
4
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Other Miscellaneous Reasons
|
1
|
0
|
Baseline Characteristics
BOTOX® in the Treatment of Upper Facial Lines in Japan
Baseline characteristics by cohort
| Measure |
Botulinum Toxin Type A (44U)
n=48 Participants
44 units (U) botulinum toxin Type A (total dose) per treatment. 24U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
|
Botulinum Toxin Type A (32U)
n=53 Participants
32 units (U) botulinum toxin Type A (total dose) per treatment. 12U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
|
Total
n=101 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
≤ 50 years
|
29 participants
n=5 Participants
|
40 participants
n=7 Participants
|
69 participants
n=5 Participants
|
|
Age, Customized
> 50 years
|
19 participants
n=5 Participants
|
13 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 30Population: Intent-to-treat population included all enrolled participants.
The Investigator assessed the severity of the participant'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 (44U)
n=48 Participants
44 units (U) botulinum toxin Type A (total dose) per treatment. 24U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
|
Botulinum Toxin Type A (32U)
n=53 Participants
32 units (U) botulinum toxin Type A (total dose) per treatment. 12U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
|
|---|---|---|
|
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)
|
89.6 percentage of participants
|
84.9 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 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 at Day 30. The percentage of participants who reported Much Improved or Very Much Improved at Day 30 is reported.
Outcome measures
| Measure |
Botulinum Toxin Type A (44U)
n=48 Participants
44 units (U) botulinum toxin Type A (total dose) per treatment. 24U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
|
Botulinum Toxin Type A (32U)
n=53 Participants
32 units (U) botulinum toxin Type A (total dose) per treatment. 12U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
|
|---|---|---|
|
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 (SGA-CFL)
|
87.6 percentage of participants
|
77.4 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Day 30Population: Intent-to-treat population included all enrolled participants. Only participants with FLO-11 Item 2 scores ≥2 at Baseline are included in the analysis.
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 was scored on an 11-point scale (0=not at all, 5=somewhat, 10=very much). FLO-11 responders were defined as the percentage of participants with a ≥2-point improvement from Baseline in FLO-11 Item 2 : "When I look in the mirror, my facial lines make me look older than I want to look" score.
Outcome measures
| Measure |
Botulinum Toxin Type A (44U)
n=46 Participants
44 units (U) botulinum toxin Type A (total dose) per treatment. 24U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
|
Botulinum Toxin Type A (32U)
n=50 Participants
32 units (U) botulinum toxin Type A (total dose) per treatment. 12U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
|
|---|---|---|
|
Percentage of Participants With a ≥2-Point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 2 at Day 30
|
84.8 percentage of participants
|
88.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Day 30Population: Intent-to-treat population included all enrolled participants. Only participants with FLO-11 Item 5 scores ≥2 at Baseline are included in the analysis.
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 was scored using an 11-point scale (0=not at all, 5=somewhat, 10=very much). FLO-11 responders were defined as the percentage of participants with a ≥2-point improvement from Baseline in FLO-11 Score Item 5: "My facial lines make me look less attractive than I want to look" score.
Outcome measures
| Measure |
Botulinum Toxin Type A (44U)
n=46 Participants
44 units (U) botulinum toxin Type A (total dose) per treatment. 24U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
|
Botulinum Toxin Type A (32U)
n=51 Participants
32 units (U) botulinum toxin Type A (total dose) per treatment. 12U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
|
|---|---|---|
|
Percentage of Participants With a ≥2-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 5 at Day 30
|
73.9 percentage of participants
|
72.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Day 30Population: Intent-to-treat population included all enrolled participants. Only participants with FLO-11 Item 8 scores ≥ 3 at Baseline were included in the analysis.
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 was scored on an 11-point scale (0=not at all, 5=somewhat, 10=very much) FLO-11 responders were defined as the percentage of participants with a ≥3-point improvement from Baseline in FLO-11 Item 8: "My facial lines make me look tired" score.
Outcome measures
| Measure |
Botulinum Toxin Type A (44U)
n=43 Participants
44 units (U) botulinum toxin Type A (total dose) per treatment. 24U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
|
Botulinum Toxin Type A (32U)
n=49 Participants
32 units (U) botulinum toxin Type A (total dose) per treatment. 12U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
|
|---|---|---|
|
Percentage of Participants With a ≥3-Point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 8 at Day 30
|
86.0 percentage of participants
|
69.4 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, 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 (44U)
n=46 Participants
44 units (U) botulinum toxin Type A (total dose) per treatment. 24U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
|
Botulinum Toxin Type A (32U)
n=51 Participants
32 units (U) botulinum toxin Type A (total dose) per treatment. 12U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
|
|---|---|---|
|
Percentage of Participants Who Rate Themselves in a Younger Self-Perception of Age Category Than at Baseline
|
54.3 percentage of participants
|
56.9 percentage of participants
|
SECONDARY outcome
Timeframe: Day 30Population: Intent-to-treat population included all enrolled participants.
Participants assessed their overall satisfaction at the present moment using a 5-point scale where -2=very dissatisfied, -1=mostly dissatisfied, 0=neither dissatisfied nor satisfied, 1=mostly satisfied and 2=very satisfied. The percentage of participants mostly or very satisfied is reported.
Outcome measures
| Measure |
Botulinum Toxin Type A (44U)
n=48 Participants
44 units (U) botulinum toxin Type A (total dose) per treatment. 24U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
|
Botulinum Toxin Type A (32U)
n=53 Participants
32 units (U) botulinum toxin Type A (total dose) per treatment. 12U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
|
|---|---|---|
|
Percentage of Participants Mostly or Very Satisfied With Their Crow's Feet Lines on the Facial Line Satisfaction Questionnaire
|
81.3 percentage of participants
|
81.1 percentage of participants
|
Adverse Events
Botulinum Toxin Type A (44U)
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Botulinum Toxin Type A (32U)
Serious events: 4 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Botulinum Toxin Type A (44U)
n=47 participants at risk
44 units (U) botulinum toxin Type A (total dose) per treatment. 24U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
|
Botulinum Toxin Type A (32U)
n=53 participants at risk
32 units (U) botulinum toxin Type A (total dose) per treatment. 12U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
|
|---|---|---|
|
Infections and infestations
Hepatitis A
|
2.1%
1/47
The Safety Population, all enrolled participants who received study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/53
The Safety Population, all enrolled participants who received study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/47
The Safety Population, all enrolled participants who received study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
1.9%
1/53
The Safety Population, all enrolled participants who received study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Reproductive system and breast disorders
Bartholin's cyst
|
0.00%
0/44
The Safety Population, all enrolled participants who received study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
2.1%
1/48
The Safety Population, all enrolled participants who received study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign female reproductive tract neoplasm
|
0.00%
0/44
The Safety Population, all enrolled participants who received study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
2.1%
1/48
The Safety Population, all enrolled participants who received study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/47
The Safety Population, all enrolled participants who received study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
1.9%
1/53
The Safety Population, all enrolled participants who received study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/47
The Safety Population, all enrolled participants who received study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
1.9%
1/53
The Safety Population, all enrolled participants who received study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
Other adverse events
| Measure |
Botulinum Toxin Type A (44U)
n=47 participants at risk
44 units (U) botulinum toxin Type A (total dose) per treatment. 24U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
|
Botulinum Toxin Type A (32U)
n=53 participants at risk
32 units (U) botulinum toxin Type A (total dose) per treatment. 12U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
|
|---|---|---|
|
General disorders
Injection site haemorrhage
|
19.1%
9/47
The Safety Population, all enrolled participants who received study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
11.3%
6/53
The Safety Population, all enrolled participants who received study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Infections and infestations
Nasopharyngitis
|
10.6%
5/47
The Safety Population, all enrolled participants who received study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
11.3%
6/53
The Safety Population, all enrolled participants who received study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Eye disorders
Eyelid ptosis
|
8.5%
4/47
The Safety Population, all enrolled participants who received study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
3.8%
2/53
The Safety Population, all enrolled participants who received study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
4.3%
2/47
The Safety Population, all enrolled participants who received study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
9.4%
5/53
The Safety Population, all enrolled participants who received study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/47
The Safety Population, all enrolled participants who received study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
5.7%
3/53
The Safety Population, all enrolled participants who received study drug, was used to determine 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