Trial Outcomes & Findings for A Study of Subject Satisfaction With BOTOX® Cosmetic Treatment in Facial Rhytides (NCT NCT01777620)
NCT ID: NCT01777620
Last Updated: 2019-04-17
Results Overview
Participants assessed their overall satisfaction with their glabellar (frown) lines using the FLSQ 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 with responses mostly or very satisfied is reported.
COMPLETED
PHASE4
125 participants
Day 60
2019-04-17
Participant Flow
Participant milestones
| Measure |
BOTOX®
BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
|
Placebo
Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
|
|---|---|---|
|
Overall Study
STARTED
|
63
|
62
|
|
Overall Study
COMPLETED
|
62
|
62
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
BOTOX®
BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
|
Placebo
Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
|
|---|---|---|
|
Overall Study
Subject Withdrawal
|
1
|
0
|
Baseline Characteristics
A Study of Subject Satisfaction With BOTOX® Cosmetic Treatment in Facial Rhytides
Baseline characteristics by cohort
| Measure |
BOTOX®
n=60 Participants
BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
|
Placebo
n=57 Participants
Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
|
Total
n=117 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
< 45 years
|
25 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
|
Age, Customized
45 - 65 years
|
35 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
68 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
98 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 60Population: Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations.
Participants assessed their overall satisfaction with their glabellar (frown) lines using the FLSQ 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 with responses mostly or very satisfied is reported.
Outcome measures
| Measure |
BOTOX®
n=60 Participants
BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
|
Placebo
n=57 Participants
Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
|
|---|---|---|
|
Percentage of Participants Satisfied With Treatment of Glabellar Lines Assessed Using the Facial Line Satisfaction Questionnaire (FLSQ)
|
81.7 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 60Population: Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations.
Participants assessed their overall satisfaction with both their CFL and glabellar lines using the FLSQ 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 |
BOTOX®
n=60 Participants
BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
|
Placebo
n=57 Participants
Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
|
|---|---|---|
|
Percentage of Participants Satisfied With Treatment of Crow's Feet Lines (CFL) and Glabellar Lines Assessed Using the FLSQ
|
81.7 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 90Population: Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations.
Participants assessed their overall satisfaction with duration of treatment of glabellar lines using the FLSQ 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 with responses mostly or very satisfied is reported.
Outcome measures
| Measure |
BOTOX®
n=60 Participants
BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
|
Placebo
n=57 Participants
Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
|
|---|---|---|
|
Percentage of Participants Satisfied With Duration of Treatment of Glabellar Lines Assessed Using the FLSQ
|
65.0 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 60Population: Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations.
Participants assessed whether treatment of their glabellar lines met expectation using the FLSQ 3-point scale where: 1=Worse than expected, 2=Met expectations and 3=Better than expected. The percentage of participants with responses Met expectations and Better than expected is reported.
Outcome measures
| Measure |
BOTOX®
n=60 Participants
BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
|
Placebo
n=57 Participants
Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
|
|---|---|---|
|
Percentage of Participants Where Treatment of Glabellar Lines Met Expectation Assessed Using the FLSQ
|
88.3 Percentage of participants
|
14.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 90Population: Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations.
Participants assessed their overall satisfaction with duration of treatment of both CFL and glabellar lines using the FLSQ 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 with responses mostly or very satisfied is reported.
Outcome measures
| Measure |
BOTOX®
n=60 Participants
BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
|
Placebo
n=57 Participants
Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
|
|---|---|---|
|
Percentage of Participants Satisfied With Duration of Treatment of CFL and Glabellar Lines Assessed Using the FLSQ
|
61.7 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 60Population: Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations.
Participants assessed whether treatment of glabellar lines met expectations using the FLSQ 3-point scale where: 1=Worse than expected, 2=Met expectations and 3=Better than expected. The percentage of participants with responses Met expectations and Better than expected is reported.
Outcome measures
| Measure |
BOTOX®
n=60 Participants
BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
|
Placebo
n=57 Participants
Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
|
|---|---|---|
|
Percentage of Participants Where Treatment of CFL and Glabellar Lines Met Expectation Assessed Using the FLSQ
|
86.7 Percentage of participants
|
15.8 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 90Population: Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations.
Participants assessed how likely they were to continue treatment of glabellar Lines using the FLSQ 5-point scale where: 1=Not at all, 2=A little bit, 3=Moderately, 4=Quite a bit and 5=Extremely. The percentage of participants with responses Moderately, Quite a bit and Extremely is reported.
Outcome measures
| Measure |
BOTOX®
n=60 Participants
BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
|
Placebo
n=57 Participants
Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
|
|---|---|---|
|
Percentage of Participants Who Were Likely to Continue Treatment of Glabellar Lines Assessed Using the FLSQ
|
78.3 Percentage of participants
|
36.8 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 90Population: Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations.
Participants assessed how likely they were to continue treatment of CFL and glabellar Lines using the FLSQ 5-point scale where: 1=Not at all, 2=A little bit, 3=Moderately, 4=Quite a bit and 5=Extremely. The percentage of participants with responses Moderately, Quite a bit and Extremely is reported.
Outcome measures
| Measure |
BOTOX®
n=60 Participants
BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
|
Placebo
n=57 Participants
Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
|
|---|---|---|
|
Percentage of Participants Who Were Likely to Continue Treatment of CFL and Glabellar Lines Assessed Using the FLSQ
|
78.3 Percentage of participants
|
31.6 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 30Population: Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations.
The Investigator assessed the severity of the patient's glabellar lines at maximum frown using the 4-point Facial Wrinkle Scale (FWS) where: 0=none, 1=mild, 2=moderate, and 3=severe. The percentage of participants with a score of none or mild is reported.
Outcome measures
| Measure |
BOTOX®
n=60 Participants
BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
|
Placebo
n=57 Participants
Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
|
|---|---|---|
|
Percentage of Participants With a Score of None or Mild in the Investigator's Assessment of the Severity of Glabellar Lines at Maximum Frown Assessed Using the FWS
|
83.3 Percentage of participants
|
1.8 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Day 30Population: Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations.
The Investigator assessed the severity of the patient's CFL at maximum smile using the 4-point FWS where: 0=none, 1=mild, 2=moderate, and 3=severe. The percentage of participants with at least a 1-Grade improvement from Baseline is reported.
Outcome measures
| Measure |
BOTOX®
n=60 Participants
BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
|
Placebo
n=57 Participants
Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
|
|---|---|---|
|
Percentage of Participants With at Least a 1-Grade Improvement in the Investigator's Assessment of the Severity of CFL at Maximum Smile Assessed Using the FWS
|
86.7 Percentage of participants
|
8.8 Percentage of participants
|
Adverse Events
BOTOX®
Placebo
Serious adverse events
| Measure |
BOTOX®
n=63 participants at risk
BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
|
Placebo
n=62 participants at risk
Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
1.6%
1/63
|
0.00%
0/62
|
Other adverse events
| Measure |
BOTOX®
n=63 participants at risk
BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
|
Placebo
n=62 participants at risk
Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
|
|---|---|---|
|
Nervous system disorders
Headache
|
9.5%
6/63
|
6.5%
4/62
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place