Trial Outcomes & Findings for Treatment With Botulinum Toxin Type A (BOTOX®) in Chinese Patients With Moderate to Severe Frown Lines (NCT NCT01814670)

Results Overview

The Investigator assessed the severity of the subject's glabellar rhytides at maximum contraction using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a ≥ 1-grade improvement from Day 1 is reported.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

185 participants

Primary outcome timeframe

Day 1, Day 30

Results posted on

2019-04-17

Participant Flow

Participant milestones

Participant milestones
Measure	Botulinum Toxin Type A 20 units botulinum toxin Type A (total dose) injected into frown lines on Day 1.
Overall Study STARTED	185
Overall Study COMPLETED	173
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Botulinum Toxin Type A 20 units botulinum toxin Type A (total dose) injected into frown lines on Day 1.
Overall Study Protocol Violation	12

Baseline Characteristics

Treatment With Botulinum Toxin Type A (BOTOX®) in Chinese Patients With Moderate to Severe Frown Lines

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Botulinum Toxin Type A n=185 Participants 20 units botulinum toxin Type A (total dose) injected into frown lines on Day 1.
Age, Continuous	44.8 Years STANDARD_DEVIATION 8.16 • n=5 Participants
Sex: Female, Male Female	180 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1, Day 30

Population: Intent-to-Treat: all eligible subjects enrolled in the study who received study treatment (BOTOX®) at Day 1

The Investigator assessed the severity of the subject's glabellar rhytides at maximum contraction using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a ≥ 1-grade improvement from Day 1 is reported.

Outcome measures

Outcome measures
Measure	Botulinum Toxin Type A n=173 Participants 20 units botulinum toxin Type A (total dose) injected into frown lines on Day 1.
Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Investigator Assessed Facial Wrinkle Scale of Glabellar Rhytides at Maximum Contraction	97.1 Percentage of Subjects

SECONDARY outcome

Timeframe: Day 1, Day 14, Day 90, Day 120

Population: Intent-to-Treat: all eligible subjects enrolled in the study who received study treatment (BOTOX®) at Day 1

The Investigator assessed the severity of the subject's glabellar rhytides at maximum contraction using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a ≥ 1-grade improvement from Day 1 is reported.

Outcome measures

Outcome measures
Measure	Botulinum Toxin Type A n=173 Participants 20 units botulinum toxin Type A (total dose) injected into frown lines on Day 1.
Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Investigator Assessed Facial Wrinkle Scale of Glabellar Rhytides at Maximum Contraction Day 14	97.1 Percentage of Subjects
Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Investigator Assessed Facial Wrinkle Scale of Glabellar Rhytides at Maximum Contraction Day 90	90.2 Percentage of Subjects
Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Investigator Assessed Facial Wrinkle Scale of Glabellar Rhytides at Maximum Contraction Day 120	81.5 Percentage of Subjects

SECONDARY outcome

Timeframe: Day 1, Day 14, Day 30, Day 90, Day 120

Population: Intent-to-Treat: all eligible subjects enrolled in the study who received study treatment (BOTOX®) at Day 1 and had data at the noted time point

The subject assessed the severity of his/her glabellar rhytides at maximum contraction using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a ≥ 1-grade improvement from Day 1 is reported.

Outcome measures

Outcome measures
Measure	Botulinum Toxin Type A n=173 Participants 20 units botulinum toxin Type A (total dose) injected into frown lines on Day 1.
Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Subject Assessed Facial Wrinkle Scale of Glabellar Rhytides at Maximum Contraction Day 14	90.1 Percentage of Subjects
Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Subject Assessed Facial Wrinkle Scale of Glabellar Rhytides at Maximum Contraction Day 30	93.1 Percentage of Subjects
Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Subject Assessed Facial Wrinkle Scale of Glabellar Rhytides at Maximum Contraction Day 90	81.5 Percentage of Subjects
Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Subject Assessed Facial Wrinkle Scale of Glabellar Rhytides at Maximum Contraction Day 120	72.3 Percentage of Subjects

SECONDARY outcome

Timeframe: Day 1, Day 14, Day 30, Day 90, Day 120

Population: Intent-to-Treat: all eligible subjects enrolled in the study who received study treatment (BOTOX®) at Day 1

The Investigator assessed the severity of the subject's glabellar rhytides at rest using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a ≥ 1-grade improvement from Day 1 is reported.

Outcome measures

Outcome measures
Measure	Botulinum Toxin Type A n=173 Participants 20 units botulinum toxin Type A (total dose) injected into frown lines on Day 1.
Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Investigator Assessed Facial Wrinkle Scale of Glabellar Rhytides at Rest Day 14	62.7 Percentage of Subjects
Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Investigator Assessed Facial Wrinkle Scale of Glabellar Rhytides at Rest Day 30	65.7 Percentage of Subjects
Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Investigator Assessed Facial Wrinkle Scale of Glabellar Rhytides at Rest Day 90	65.7 Percentage of Subjects
Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Investigator Assessed Facial Wrinkle Scale of Glabellar Rhytides at Rest Day 120	62.7 Percentage of Subjects

SECONDARY outcome

Timeframe: Day 1, Day 14, Day 30, Day 90, Day 120

Population: Intent-to-Treat: all eligible subjects enrolled in the study who received study treatment (BOTOX®) at Day 1

The Subject assessed the severity of his/her glabellar rhytides at rest using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a ≥ 1-grade improvement from Day 1 is reported.

Outcome measures

Outcome measures
Measure	Botulinum Toxin Type A n=173 Participants 20 units botulinum toxin Type A (total dose) injected into frown lines on Day 1.
Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Subject Assessed Facial Wrinkle Scale of Glabellar Rhytides at Rest Day 14	59.9 Percentage of Subjects
Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Subject Assessed Facial Wrinkle Scale of Glabellar Rhytides at Rest Day 30	58.4 Percentage of Subjects
Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Subject Assessed Facial Wrinkle Scale of Glabellar Rhytides at Rest Day 90	50.9 Percentage of Subjects
Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Subject Assessed Facial Wrinkle Scale of Glabellar Rhytides at Rest Day 120	49.1 Percentage of Subjects

Adverse Events

Botulinum Toxin Type A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Vice President Medical Affairs,

Allergan, Inc

Phone: 714-246-4500

Email: [email protected]

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