MedDataX Logo

Trial Outcomes & Findings for Patient Satisfaction Study of BOTOX® Cosmetic in the Treatment of Moderate to Severe Frown Lines (NCT NCT01391312)

NCT ID: NCT01391312

Last Updated: 2012-09-25

Results Overview

Subjects assessed the improvement of their glabellar lines (area between the eyebrows) by answering the question: Compared to before receiving the study treatment, How do you currently feel about the appearance of your glabellar lines? on a 7-point scale where 0=Very much improved, 1=Much improved, 2=Minimally improved, 3=No change, 4=Minimally worse, 5=Much worse, 6=Very much worse. Improvement was defined as responses: 0=Very much improved, 1=Much improved and 2=Minimally improved.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

40 participants

Primary outcome timeframe

Day 30

Results posted on

2012-09-25

Participant Flow

Participant milestones

Participant milestones
Measure
Botulinum Toxin Type A
Botulinum toxin Type A 20U (total dose) injected into the glabellar region on Day 0.
Placebo (Normal Saline)
Normal Saline (placebo) injected into the glabellar region on Day 0.
Overall Study
STARTED
20
20
Overall Study
COMPLETED
18
19
Overall Study
NOT COMPLETED
2
1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Patient Satisfaction Study of BOTOX® Cosmetic in the Treatment of Moderate to Severe Frown Lines

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Botulinum Toxin Type A
n=20 Participants
Botulinum toxin Type A 20U (total dose) injected into the glabellar region on Day 0.
Placebo (Normal Saline)
n=20 Participants
Normal Saline (placebo) injected into the glabellar region on Day 0.
Total
n=40 Participants
Total of all reporting groups
Age Continuous
46.3 Years
STANDARD_DEVIATION 12.8 • n=5 Participants
54.5 Years
STANDARD_DEVIATION 7.1 • n=7 Participants
50.4 Years
STANDARD_DEVIATION 11.0 • n=5 Participants
Sex: Female, Male
Female
20 Participants
n=5 Participants
20 Participants
n=7 Participants
40 Participants
n=5 Participants
Sex: Female, Male
Male
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Day 30

Population: Participants from the Intent-to-treat population (all randomized participants) with data available for the time-point.

Subjects assessed the improvement of their glabellar lines (area between the eyebrows) by answering the question: Compared to before receiving the study treatment, How do you currently feel about the appearance of your glabellar lines? on a 7-point scale where 0=Very much improved, 1=Much improved, 2=Minimally improved, 3=No change, 4=Minimally worse, 5=Much worse, 6=Very much worse. Improvement was defined as responses: 0=Very much improved, 1=Much improved and 2=Minimally improved.

Outcome measures

Outcome measures
Measure
Botulinum Toxin Type A
n=19 Participants
Botulinum toxin Type A 20U (total dose) injected into the glabellar region on Day 0.
Placebo (Normal Saline)
n=20 Participants
Normal Saline (placebo) injected into the glabellar region on Day 0.
Percentage of Participants With Improvement in Subject Global Assessment of Change at Day 30
94.7 Percentage of participants
0.84
0.00 Percentage of participants
0.00

SECONDARY outcome

Timeframe: Day 30

Population: Participants from the Intent-to-treat population (all randomized participants) with data available for the time-point.

The Investigator rated the subject's severity of glabellar lines (between the eyebrows) at maximum attempted muscle contraction using the 4-point Facial Wrinkle scale where 0=None (Best), 1=Mild, 2=Moderate, 3=Severe (Worse) at day 30. Responders were defined as participants with a score of 0=None or 1=Mild.

Outcome measures

Outcome measures
Measure
Botulinum Toxin Type A
n=19 Participants
Botulinum toxin Type A 20U (total dose) injected into the glabellar region on Day 0.
Placebo (Normal Saline)
n=20 Participants
Normal Saline (placebo) injected into the glabellar region on Day 0.
Percentage of Facial Wrinkle Scale Responders at Maximum Attempted Muscle Contraction at Day 30
100 Percentage of participants
10 Percentage of participants

SECONDARY outcome

Timeframe: Day 60

Population: Participants from the Intent-to-treat population (all randomized participants) with data available for the time-point.

The Investigator rated the subject's severity of glabellar lines (between the eyebrows) at maximum attempted muscle contraction using the 4-point Facial Wrinkle scale where 0=None (Best), 1=Mild, 2=Moderate, 3=Severe (Worse) at day 60. Responders were defined as participants with a score of 0=None or 1=Mild.

Outcome measures

Outcome measures
Measure
Botulinum Toxin Type A
n=18 Participants
Botulinum toxin Type A 20U (total dose) injected into the glabellar region on Day 0.
Placebo (Normal Saline)
n=19 Participants
Normal Saline (placebo) injected into the glabellar region on Day 0.
Percentage of Facial Wrinkle Scale Responders at Maximum Attempted Muscle Contraction at Day 60
77.8 Percentage of participants
5.3 Percentage of participants

Adverse Events

Botulinum Toxin Type A

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Placebo (Normal Saline)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Botulinum Toxin Type A
n=19 participants at risk
Botulinum toxin Type A 20U (total dose) injected into the glabellar region on Day 0.
Placebo (Normal Saline)
n=20 participants at risk
Normal Saline (placebo) injected into the glabellar region on Day 0.
Respiratory, thoracic and mediastinal disorders
Coughing
5.3%
1/19
Serious adverse events and adverse events were assessed in all participants with at least 1 post-baseline assessment.
0.00%
0/20
Serious adverse events and adverse events were assessed in all participants with at least 1 post-baseline assessment.
General disorders
Very small bruise
5.3%
1/19
Serious adverse events and adverse events were assessed in all participants with at least 1 post-baseline assessment.
0.00%
0/20
Serious adverse events and adverse events were assessed in all participants with at least 1 post-baseline assessment.

Additional Information

Vice President Medical Affairs,

Allergan, Inc

Phone: 714-246-4500

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