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Trial Outcomes & Findings for Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Forehead and Frown Lines (NCT NCT01391299)

NCT ID: NCT01391299

Last Updated: 2019-04-17

Results Overview

The Investigator assessed the severity of the patient's forehead lines at maximum eyebrow elevation using the 4-point FWS: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a score of none or mild at Day 30.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

175 participants

Primary outcome timeframe

Day 30

Results posted on

2019-04-17

Participant Flow

Participant milestones

Participant milestones
Measure
Botulinum Toxin Type A (40 Units)
Botulinum toxin Type A 40 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
Botulinum Toxin Type A (30 Units)
Botulinum toxin Type A 30 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
Placebo (Normal Saline)
Placebo (Normal saline) injected into bilateral forehead and frown lines areas on Day 1.
Overall Study
STARTED
57
60
58
Overall Study
COMPLETED
57
59
56
Overall Study
NOT COMPLETED
0
1
2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Forehead and Frown Lines

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Botulinum Toxin Type A (40 Units)
n=57 Participants
Botulinum toxin Type A 40 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
Botulinum Toxin Type A (30 Units)
n=60 Participants
Botulinum toxin Type A 30 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
Placebo (Normal Saline)
n=58 Participants
Placebo (Normal saline) injected into bilateral forehead and frown lines areas on Day 1.
Total
n=175 Participants
Total of all reporting groups
Age, Customized
<45 years
28 Participants
n=5 Participants
25 Participants
n=7 Participants
22 Participants
n=5 Participants
75 Participants
n=4 Participants
Age, Customized
45 to 65 years
26 Participants
n=5 Participants
31 Participants
n=7 Participants
35 Participants
n=5 Participants
92 Participants
n=4 Participants
Age, Customized
>65 years
3 Participants
n=5 Participants
4 Participants
n=7 Participants
1 Participants
n=5 Participants
8 Participants
n=4 Participants
Sex: Female, Male
Female
50 Participants
n=5 Participants
50 Participants
n=7 Participants
52 Participants
n=5 Participants
152 Participants
n=4 Participants
Sex: Female, Male
Male
7 Participants
n=5 Participants
10 Participants
n=7 Participants
6 Participants
n=5 Participants
23 Participants
n=4 Participants

PRIMARY outcome

Timeframe: Day 30

Population: Intent-to-treat population included all randomized participants.

The Investigator assessed the severity of the patient's forehead lines at maximum eyebrow elevation using the 4-point FWS: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a score of none or mild at Day 30.

Outcome measures

Outcome measures
Measure
Botulinum Toxin Type A (40 Units)
n=57 Participants
Botulinum toxin Type A 40 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
Botulinum Toxin Type A (30 Units)
n=60 Participants
Botulinum toxin Type A 30 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
Placebo (Normal Saline)
n=58 Participants
Placebo (Normal saline) injected into bilateral forehead and frown lines areas on Day 1.
Percentage of Participants Achieving a Score of None or Mild by Investigator-Assessed Facial Wrinkle Scale With Photonumeric Guide (FWS) in Forehead Lines at Maximum Eyebrow Elevation
89.5 Percentage of participants
85.0 Percentage of participants
3.4 Percentage of participants

PRIMARY outcome

Timeframe: Day 30

Population: Intent-to-treat population included all randomized participants.

The patient assessed the severity of their forehead lines at maximum eyebrow elevation using the 4-point FWS: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a score of none or mild at Day 30.

Outcome measures

Outcome measures
Measure
Botulinum Toxin Type A (40 Units)
n=57 Participants
Botulinum toxin Type A 40 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
Botulinum Toxin Type A (30 Units)
n=60 Participants
Botulinum toxin Type A 30 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
Placebo (Normal Saline)
n=58 Participants
Placebo (Normal saline) injected into bilateral forehead and frown lines areas on Day 1.
Percentage of Participants Achieving a Score of None or Mild by Subject-Assessed Facial Wrinkle Scale With Photonumeric Guide (FWS) in Forehead Lines at Maximum Eyebrow Elevation
87.7 Percentage of participants
80.0 Percentage of participants
6.9 Percentage of participants

SECONDARY outcome

Timeframe: Day 30

Population: Includes participants from the Intent-to-treat Population (all randomized participants) with a rating of very unsatisfied, unsatisfied or neutral in the Subject's Assessment of Satisfaction of Appearance at baseline.

Participants rated their overall satisfaction with the appearance of the forehead line area using a 5-point scale: 1=very unsatisfied, 2=unsatisfied, 3=neutral, 4=satisfied or 5=very satisfied. The percentage of participants with a rating of satisfied or very satisfied at Day 30.

Outcome measures

Outcome measures
Measure
Botulinum Toxin Type A (40 Units)
n=54 Participants
Botulinum toxin Type A 40 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
Botulinum Toxin Type A (30 Units)
n=58 Participants
Botulinum toxin Type A 30 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
Placebo (Normal Saline)
n=57 Participants
Placebo (Normal saline) injected into bilateral forehead and frown lines areas on Day 1.
Percentage of Participants Achieving Satisfied or Very Satisfied by Subject Assessment of Satisfaction of Appearance of Forehead Lines
94.4 Percentage of participants
81.0 Percentage of participants
1.8 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Day 30

Population: Participants from the intent-to-treat population (all randomized participants) with a Facial Wrinkle Score of at least mild at baseline.

The Investigator assessed the severity of the patient's forehead lines at rest using the 4-point FWS: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a ≥1 grade improvement from baseline.

Outcome measures

Outcome measures
Measure
Botulinum Toxin Type A (40 Units)
n=56 Participants
Botulinum toxin Type A 40 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
Botulinum Toxin Type A (30 Units)
n=60 Participants
Botulinum toxin Type A 30 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
Placebo (Normal Saline)
n=58 Participants
Placebo (Normal saline) injected into bilateral forehead and frown lines areas on Day 1.
Percentage of Participants With a ≥1 Grade Improvement From Baseline by Investigator-Assessed FWS in Forehead Lines at Rest
91.1 Percentage of participants
83.3 Percentage of participants
15.5 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Day 30

Population: Participants from the intent-to-treat population (all randomized participants) with a Facial Wrinkle Score of at least mild at baseline.

Participants assessed the severity of their forehead lines at rest using the 4-point FWS: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a ≥1 grade improvement from baseline.

Outcome measures

Outcome measures
Measure
Botulinum Toxin Type A (40 Units)
n=57 Participants
Botulinum toxin Type A 40 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
Botulinum Toxin Type A (30 Units)
n=60 Participants
Botulinum toxin Type A 30 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
Placebo (Normal Saline)
n=58 Participants
Placebo (Normal saline) injected into bilateral forehead and frown lines areas on Day 1.
Percentage of Participants With a ≥1 Grade Improvement From Baseline by Subject-Assessed FWS in Forehead Lines at Rest
89.5 Percentage of participants
88.3 Percentage of participants
17.2 Percentage of participants

Adverse Events

Botulinum Toxin Type A (40 Units)

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

Botulinum Toxin Type A (30 Units)

Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths

Placebo (Normal Saline)

Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Botulinum Toxin Type A (40 Units)
n=57 participants at risk
Botulinum toxin Type A 40 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
Botulinum Toxin Type A (30 Units)
n=60 participants at risk
Botulinum toxin Type A 30 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
Placebo (Normal Saline)
n=58 participants at risk
Placebo (Normal saline) injected into bilateral forehead and frown lines areas on Day 1.
Nervous system disorders
Nerve compression
0.00%
0/57
0.00%
0/60
1.7%
1/58

Other adverse events

Other adverse events
Measure
Botulinum Toxin Type A (40 Units)
n=57 participants at risk
Botulinum toxin Type A 40 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
Botulinum Toxin Type A (30 Units)
n=60 participants at risk
Botulinum toxin Type A 30 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
Placebo (Normal Saline)
n=58 participants at risk
Placebo (Normal saline) injected into bilateral forehead and frown lines areas on Day 1.
Infections and infestations
Nasopharyngitis
1.8%
1/57
8.3%
5/60
3.4%
2/58
Infections and infestations
Lower respiratory tract infection
0.00%
0/57
0.00%
0/60
5.2%
3/58
Nervous system disorders
Headache
1.8%
1/57
5.0%
3/60
5.2%
3/58

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