Trial Outcomes & Findings for BOTOX® in the Treatment of Crow's Feet Lines in China (NCT NCT02195687)

Results Overview

The Investigator assessed the severity of the subject's CFLs at maximum smile using the 4-point FWS-A where 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a score of none or mild at Day 30 is reported.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

417 participants

Primary outcome timeframe

Day 30

Results posted on

2016-03-14

Participant Flow

The participant flow reflects the Safety Population, which includes all randomized subjects who received at least 1 study drug injection.

Participant milestones

Participant milestones
Measure	Botulinum Toxin Type A 24U botulinum toxin Type A (BOTOX®) total dose injected into bilateral Crow's Feet Line areas on Day 1.	Placebo Placebo (Normal Saline) injected into bilateral Crow's Feet Line areas on Day 1.
Overall Study STARTED	316	101
Overall Study COMPLETED	311	99
Overall Study NOT COMPLETED	5	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Botulinum Toxin Type A 24U botulinum toxin Type A (BOTOX®) total dose injected into bilateral Crow's Feet Line areas on Day 1.	Placebo Placebo (Normal Saline) injected into bilateral Crow's Feet Line areas on Day 1.
Overall Study Personal Reasons	1	1
Overall Study Lost to Follow-up	4	1

Baseline Characteristics

BOTOX® in the Treatment of Crow's Feet Lines in China

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Botulinum Toxin Type A n=316 Participants 24U botulinum toxin Type A (BOTOX®) total dose injected into bilateral Crow's Feet Line areas on Day 1.	Placebo n=101 Participants Placebo (Normal Saline) injected into bilateral Crow's Feet Line areas on Day 1.	Total n=417 Participants Total of all reporting groups
Age, Continuous	46.3 Years STANDARD_DEVIATION 9.64 • n=5 Participants	46.6 Years STANDARD_DEVIATION 9.39 • n=7 Participants	46.4 Years STANDARD_DEVIATION 9.57 • n=5 Participants
Sex: Female, Male Female	273 Participants n=5 Participants	87 Participants n=7 Participants	360 Participants n=5 Participants
Sex: Female, Male Male	43 Participants n=5 Participants	14 Participants n=7 Participants	57 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 30

Population: Modified Intent-to-Treat: all randomized subjects who received at least 1 injection of study drug

The Investigator assessed the severity of the subject's CFLs at maximum smile using the 4-point FWS-A where 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a score of none or mild at Day 30 is reported.

Outcome measures

Outcome measures
Measure	Botulinum Toxin Type A n=316 Participants 24U botulinum toxin Type A (BOTOX®) total dose injected into bilateral Crow's Feet Line areas on Day 1.	Placebo n=101 Participants Placebo (Normal Saline) injected into bilateral Crow's Feet Line areas on Day 1.
Percentage of Subjects Achieving None or Mild on the Investigator's Assessment of the Severity of Crow's Feet Lines (CFL) at Maximum Smile Using the Facial Wrinkle Scale-Asian (FWS-A)	63.9 Percentage of Subjects	5.0 Percentage of Subjects

SECONDARY outcome

Timeframe: Day 30

Population: Modified Intent-to-Treat: all randomized subjects who received at least 1 injection of study drug

The Investigator assessed the severity of the subject's CFLs at rest using the 4-point Facial Wrinkle Scale where 0=none, 1=mild, 2=moderate or 3=severe among subjects rated as at least mild at baseline by the Investigator. The percentages of subjects with at least a 1-grade improvement are noted.

Outcome measures

Outcome measures
Measure	Botulinum Toxin Type A n=316 Participants 24U botulinum toxin Type A (BOTOX®) total dose injected into bilateral Crow's Feet Line areas on Day 1.	Placebo n=101 Participants Placebo (Normal Saline) injected into bilateral Crow's Feet Line areas on Day 1.
Percentage of Subjects With a ≥ 1-grade Improvement on the Investigator's Assessment of CFL Severity at Rest Using the 4-point FWS-A	60.1 Percentage of Subjects	5.4 Percentage of Subjects

SECONDARY outcome

Timeframe: Day 30

Population: Modified Intent-to-Treat: all randomized subjects who received at least 1 injection of study drug

The Investigator assessed the severity of the subject's CFLs at maximum smile using the 4-point Facial Wrinkle Scale where 0=none, 1=mild, 2=moderate or 3=severe. The percentages of subjects with at least a 1-grade improvement are noted.

Outcome measures

Outcome measures
Measure	Botulinum Toxin Type A n=316 Participants 24U botulinum toxin Type A (BOTOX®) total dose injected into bilateral Crow's Feet Line areas on Day 1.	Placebo n=101 Participants Placebo (Normal Saline) injected into bilateral Crow's Feet Line areas on Day 1.
Percentage of Subjects With a ≥ 1-grade Improvement on the Investigator's Assessment of CFL Severity at Maximum Smile on the 4-point FWS-A	85.1 Percentage of Subjects	12.9 Percentage of Subjects

SECONDARY outcome

Timeframe: Day 30

Population: Modified Intent-to-Treat: all randomized subjects who received at least 1 injection of study drug

Subjects assessed their global change in appearance using the 7-point SGA-CFL scale where 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse. The percentage of subjects reporting very much improved or much improved are noted.

Outcome measures

Outcome measures
Measure	Botulinum Toxin Type A n=316 Participants 24U botulinum toxin Type A (BOTOX®) total dose injected into bilateral Crow's Feet Line areas on Day 1.	Placebo n=101 Participants Placebo (Normal Saline) injected into bilateral Crow's Feet Line areas on Day 1.
Percentage of Subjects Reporting Their Global Change in Appearance as Very Much Improved or Much Improved Using the 7-point Subject's Global Assessment of Change in CFL (SGA-CFL)	54.4 Percentage of Subjects	3.0 Percentage of Subjects

SECONDARY outcome

Timeframe: Baseline, Day 30

Population: Modified Intent-to-Treat: all randomized subjects who received at least 1 injection of study drug and rated themselves as looking their current age or older at baseline

Subjects assessed their age-related appearance according to the following on the SPA questionnaire: look my current age, look younger, and look older when compared to their baseline assessment. The percentages of subjects who reported looking younger amongst subjects who rated themselves as looking their current age or older at baseline are noted.

Outcome measures

Outcome measures
Measure	Botulinum Toxin Type A n=297 Participants 24U botulinum toxin Type A (BOTOX®) total dose injected into bilateral Crow's Feet Line areas on Day 1.	Placebo n=95 Participants Placebo (Normal Saline) injected into bilateral Crow's Feet Line areas on Day 1.
Percentage of Subjects Assessing Their Age-related Facial Appearance as Looking Younger on the Self-Perception of Age (SPA) Questionnaire	53.9 Percentage of Subjects	14.7 Percentage of Subjects

SECONDARY outcome

Timeframe: Day 30

Population: Modified Intent-to-Treat: all randomized subjects who received at least 1 injection of study drug

The subject assessed the severity of their CFLs at maximum smile using the 4-point FWS-A where 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a score of none or mild at Day 30 is reported.

Outcome measures

Outcome measures
Measure	Botulinum Toxin Type A n=316 Participants 24U botulinum toxin Type A (BOTOX®) total dose injected into bilateral Crow's Feet Line areas on Day 1.	Placebo n=101 Participants Placebo (Normal Saline) injected into bilateral Crow's Feet Line areas on Day 1.
Percentage of Subjects Achieving None or Mild on the Subject's Assessment of the Severity of Crow's Feet Lines (CFL) at Maximum Smile Using the Facial Wrinkle Scale-Asian (FWS-A)	60.8 Percentage of Subjects	5.9 Percentage of Subjects

Adverse Events

Botulinum Toxin Type A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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

Therapeutic Area Head,

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