Trial Outcomes & Findings for Safety and Efficacy of Two Types of Botulinum Toxin Type A For the Treatment of Glabellar Lines (NCT NCT01271452)

NCT ID: NCT01271452

Last Updated: 2019-01-29

Results Overview

Number of subjects with a treatment response at Day 28 based on the injector's assessment of the severity of glabellar lines at maximum contraction using the FWS. The FWS measures wrinkles on a scale from 0=none (best) to 3=severe (worst). Treatment response was defined as a 1 point or greater reduction from Day 0 in the FWS score at maximum contraction.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

224 participants

Primary outcome timeframe

Day 28

Results posted on

2019-01-29

Participant Flow

Participant milestones

Participant milestones
Measure	Vistabel® botulinum toxin type A (Vistabel®)	Bocouture® botulinum toxin type A (Bocouture®)
Overall Study STARTED	112	112
Overall Study COMPLETED	105	104
Overall Study NOT COMPLETED	7	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy of Two Types of Botulinum Toxin Type A For the Treatment of Glabellar Lines

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vistabel® n=112 Participants botulinum toxin type A (Vistabel®)	Bocouture® n=112 Participants botulinum toxin type A (Bocouture®)	Total n=224 Participants Total of all reporting groups
Age, Continuous	45.0 years STANDARD_DEVIATION 10.80 • n=5 Participants	45.4 years STANDARD_DEVIATION 9.82 • n=7 Participants	45.2 years STANDARD_DEVIATION 10.30 • n=5 Participants
Sex: Female, Male Female	98 Participants n=5 Participants	102 Participants n=7 Participants	200 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	10 Participants n=7 Participants	24 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 28

Population: Intent-to-treat (ITT): all randomized subjects.

Number of subjects with a treatment response at Day 28 based on the injector's assessment of the severity of glabellar lines at maximum contraction using the FWS. The FWS measures wrinkles on a scale from 0=none (best) to 3=severe (worst). Treatment response was defined as a 1 point or greater reduction from Day 0 in the FWS score at maximum contraction.

Outcome measures

Outcome measures
Measure	Vistabel® n=112 Participants botulinum toxin type A (Vistabel®)	Bocouture® n=112 Participants botulinum toxin type A (Bocouture®)
Number of Subjects With a Treatment Response at Day 28 Based on the Injector's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the Facial Wrinkle Scale (FWS)	108 Number of Subjects	106 Number of Subjects

SECONDARY outcome

Timeframe: Day 84

Population: ITT: all randomized subjects.

Number of subjects with a treatment response at Day 84 based on the injector's assessment of the severity of glabellar lines at maximum contraction using the FWS. The FWS measures wrinkles on a scale from 0=none (best) to 3=severe (worst). Treatment response was defined as a 1 point or greater reduction from Day 0 in the FWS score at maximum contraction.

Outcome measures

Outcome measures
Measure	Vistabel® n=112 Participants botulinum toxin type A (Vistabel®)	Bocouture® n=112 Participants botulinum toxin type A (Bocouture®)
Number of Subjects With a Treatment Response at Day 84 Based on the Injector's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the FWS	90 Number of Subjects	80 Number of Subjects

SECONDARY outcome

Timeframe: Day 98

Population: ITT: all randomized subjects.

Number of subjects with a treatment response at Day 98 based on the injector's assessment of the severity of glabellar lines at maximum contraction using the FWS. The FWS measures wrinkles on a scale from 0=none (best) to 3=severe (worst). Treatment response was defined as a 1 point or greater reduction from Day 0 in the FWS score at maximum contraction.

Outcome measures

Outcome measures
Measure	Vistabel® n=112 Participants botulinum toxin type A (Vistabel®)	Bocouture® n=112 Participants botulinum toxin type A (Bocouture®)
Number of Subjects With a Treatment Response at Day 98 Based on the Injector's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the FWS	76 Number of Subjects	70 Number of Subjects

SECONDARY outcome

Timeframe: Day 112

Population: ITT: all randomized subjects.

Number of subjects with a treatment response at Day 112 based on the injector's assessment of the severity of glabellar lines at maximum contraction using the FWS. The FWS measures wrinkles on a scale from 0=none (best) to 3=severe (worst). Treatment response was defined as a 1 point or greater reduction from Day 0 in the FWS score at maximum contraction.

Outcome measures

Outcome measures
Measure	Vistabel® n=112 Participants botulinum toxin type A (Vistabel®)	Bocouture® n=112 Participants botulinum toxin type A (Bocouture®)
Number of Subjects With a Treatment Response at Day 112 Based on the Injector's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the FWS	61 Number of Subjects	56 Number of Subjects

SECONDARY outcome

Timeframe: Day 28

Population: ITT: all randomized subjects.

Number of subjects with a treatment response at Day 28 based on the subject's assessment of the severity of glabellar lines at maximum contraction using the FWS. The FWS measures wrinkles on a scale from 0=none (best) to 3=severe (worst). Treatment response was defined as a 1 point or greater reduction from Day 0 in the FWS score at maximum contraction.

Outcome measures

Outcome measures
Measure	Vistabel® n=112 Participants botulinum toxin type A (Vistabel®)	Bocouture® n=112 Participants botulinum toxin type A (Bocouture®)
Number of Subjects With a Treatment Response at Day 28 Based on the Subject's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the FWS	108 Number of Subjects	102 Number of Subjects

SECONDARY outcome

Timeframe: Day 84

Population: ITT: all randomized subjects.

Number of subjects with a treatment response at Day 84 based on the subject's assessment of the severity of glabellar lines at maximum contraction using the FWS. The FWS measures wrinkles on a scale from 0=none (best) to 3=severe (worst). Treatment response was defined as a 1 point or greater reduction from Day 0 in the FWS score at maximum contraction.

Outcome measures

Outcome measures
Measure	Vistabel® n=112 Participants botulinum toxin type A (Vistabel®)	Bocouture® n=112 Participants botulinum toxin type A (Bocouture®)
Number of Subjects With a Treatment Response at Day 84 Based on the Subject's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the FWS	84 Number of Subjects	78 Number of Subjects

SECONDARY outcome

Timeframe: Day 98

Population: ITT: all randomized subjects.

Number of subjects with a treatment response at Day 98 based on the subject's assessment of the severity of glabellar lines at maximum contraction using the FWS. The FWS measures wrinkles on a scale from 0=none (best) to 3=severe (worst). Treatment response was defined as a 1 point or greater reduction from Day 0 in the FWS score at maximum contraction.

Outcome measures

Outcome measures
Measure	Vistabel® n=112 Participants botulinum toxin type A (Vistabel®)	Bocouture® n=112 Participants botulinum toxin type A (Bocouture®)
Number of Subjects With a Treatment Response at Day 98 Based on the Subject's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the FWS	73 Number of Subjects	68 Number of Subjects

SECONDARY outcome

Timeframe: Day 112

Population: ITT: all randomized subjects.

Number of subjects with a treatment response at Day 112 based on the subject's assessment of the severity of glabellar lines at maximum contraction using the FWS. The FWS measures wrinkles on a scale from 0=none (best) to 3=severe (worst). Treatment response was defined as a 1 point or greater reduction from Day 0 in the FWS score at maximum contraction.

Outcome measures

Outcome measures
Measure	Vistabel® n=112 Participants botulinum toxin type A (Vistabel®)	Bocouture® n=112 Participants botulinum toxin type A (Bocouture®)
Number of Subjects With a Treatment Response at Day 112 Based on the Subject's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the FWS	61 Number of Subjects	54 Number of Subjects

Adverse Events

Vistabel®

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Bocouture®

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Vistabel® n=112 participants at risk botulinum toxin type A (Vistabel®)	Bocouture® n=111 participants at risk botulinum toxin type A (Bocouture®)
Infections and infestations Nasopharyngitis	5.4% 6/112 The Safety Population was used to analyze serious adverse events and adverse events and consisted of all randomised subjects who received at least one administration of study treatment (to at least one injection site). One subject in the Bocouture® treatment group was not included in the Safety Population.	1.8% 2/111 The Safety Population was used to analyze serious adverse events and adverse events and consisted of all randomised subjects who received at least one administration of study treatment (to at least one injection site). One subject in the Bocouture® treatment group was not included in the Safety Population.

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 at least 30 days from the time submitted to the sponsor for review. The sponsor can require changes to the communication and can extend the embargo
Publication restrictions are in place

Restriction type: OTHER