Trial Outcomes & Findings for An Observational Retrospective Study to Evaluate Treatment Patterns of Botulinum Toxin Type A (NCT NCT01608659)

Results Overview

Average total dose per treatment period was defined as total treatment dose plus total touch-up dose plus total follow-up dose.

Recruitment status

COMPLETED

Target enrollment

110 participants

Primary outcome timeframe

24 Months

Results posted on

2019-04-17

Participant Flow

In this retrospective chart review study, subjects received botulinum toxin Type A (BOTOX®) in study-defined Treatment Periods 1 and 3, and botulinum toxin Type A (Xeomin®) in Treatment Period 2. Data were evaluated as available for each Treatment Period.

Participant milestones

Participant milestones
Measure	Botulinum Toxin Type A Previous treatment with botulinum toxin Type A for treatment of facial lines
Overall Study STARTED	110
Overall Study COMPLETED	94
Overall Study NOT COMPLETED	16

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

An Observational Retrospective Study to Evaluate Treatment Patterns of Botulinum Toxin Type A

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Botulinum Toxin Type A n=110 Participants Previous treatment with botulinum toxin Type A for treatment of facial lines
Age, Customized ≥30 and <40 years	5 Participants n=99 Participants
Age, Customized ≥40 and <50 years	31 Participants n=99 Participants
Age, Customized ≥50 and <60 years	33 Participants n=99 Participants
Age, Customized ≥60 years	35 Participants n=99 Participants
Age, Customized Missing	6 Participants n=99 Participants
Sex: Female, Male Female	110 Participants n=99 Participants
Sex: Female, Male Male	0 Participants n=99 Participants

PRIMARY outcome

Timeframe: 24 Months

Population: All subjects enrolled in the study who were evaluated for this data point. N equals the number of subjects evaluated in each treatment period.

Average total dose per treatment period was defined as total treatment dose plus total touch-up dose plus total follow-up dose.

Outcome measures

Outcome measures
Measure	Botulinum Toxin Type A n=34 Participants Previous treatment with botulinum toxin Type A for treatment of facial lines
Average Total Dose Per Treatment Period Treatment Period 1 (BOTOX®) N=34	49.2 Units Standard Deviation 12.77
Average Total Dose Per Treatment Period Treatment Period 2 (Xeomin®) N=34	48.1 Units Standard Deviation 15.18
Average Total Dose Per Treatment Period Treatment Period 3 (BOTOX®) N=16	45.8 Units Standard Deviation 4.68

SECONDARY outcome

Timeframe: 24 Months

Population: All subjects enrolled in the study who were evaluated for this data point. N equals the number of subjects evaluated in each treatment period.

Inter-injection interval duration of each treatment period. Duration is defined as the number of days of an injection cycle.

Outcome measures

Outcome measures
Measure	Botulinum Toxin Type A n=110 Participants Previous treatment with botulinum toxin Type A for treatment of facial lines
Inter-Injection Interval Duration of Each Treatment Period Treatment Period 1 (BOTOX®) N=110	180.3 Days Full Range 94.40 • Interval 58.0 to 623.0
Inter-Injection Interval Duration of Each Treatment Period Treatment Period 2 (Xeomin®) N=106	144.3 Days Full Range 113.55 • Interval 13.0 to 658.0
Inter-Injection Interval Duration of Each Treatment Period Treatment Period 3 (BOTOX®) N=76	176.9 Days Full Range 91.43 • Interval 98.0 to 639.0

SECONDARY outcome

Timeframe: 24 Months

Population: All subjects enrolled in the study who were evaluated for this data point. N equals the number of subjects evaluated in each treatment period.

Percent of subjects reporting satisfaction with treatment effects per chart notes.

Outcome measures

Outcome measures
Measure	Botulinum Toxin Type A n=80 Participants Previous treatment with botulinum toxin Type A for treatment of facial lines
Percent of Subjects Reporting Satisfaction With Treatment Effects Treatment Period 1 (BOTOX®) N=80	99.0 Percentage of Subjects Standard Deviation 6.68
Percent of Subjects Reporting Satisfaction With Treatment Effects Treatment Period 2 (Xeomin®) N=74	33.7 Percentage of Subjects Standard Deviation 39.29
Percent of Subjects Reporting Satisfaction With Treatment Effects Treatment Period 3 (BOTOX®) N=67	90.3 Percentage of Subjects Standard Deviation 17.56

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