Primary efficacy end point: Composite investigator and subject
assessment of forehead lines severity at maximum eyebrow
elevation at Day 30–responder rates (% and number of subjects
achieving ≥2-grade improvement on FWS from baseline)1
Study | BOTOX® Cosmetic 40 units(20 Units forehead lines and 20 Units glabellar lines) | BOTOX® Cosmetic 64 units(20 Units forehead lines, 20 Units glabellar lines, and 24 units lateral canthal lines) |
Placebo | P Value |
---|---|---|---|---|
Study 1 | 61% (178/290) | - | 0% (0/101) | P<0.0001 |
Study 2 | 46% (145/318) | 53% (166/313) | 1% (1/156) | P<0.0001 |
Secondary efficacy end point: Investigator-assessed achievement
of none or mild from baseline on FWS at maximum eyebrow elevation
(treatment success)1
Study 1
Study 2
Similar results for
forehead lines1
- Response rate for forehead lines across multiple treatment cycles is similar. A total of 165 and 197 patients received 3 cycles of BOTOX® Cosmetic over 1 year, 40 Units (20 Units for forehead lines with 20 Units for glabellar lines) and 64 Units (20 Units for forehead lines, 20 Units for glabellar lines, and 24 Units for lateral canthal lines), respectively.1
BOTOX® Cosmetic provides patient satisfaction1
Using the Facial Line Satisfaction Questionnaire, 90% of subjects in Study 1 and 82% in Study 2 reported being
“Mostly Satisfied” or “Very Satisfied” with BOTOX® Cosmetic 40 Units (20 Units FHL with 20 Units GL)
treatment
compared to subjects treated with placebo (1% in Study 1 and 3% in Study 2) at Day 60
Facial Lines Satisfaction Questionnaire Response Frequency at Day 60
(Percentage of Subjects)
STUDY 1 | STUDY 2 | |||
---|---|---|---|---|
Responses | BOTOX Cosmetic (20 Units FHL with 20 Units GL) N=289 |
Placebo N=99 |
BOTOX Cosmetic (20 Units FHL with 20 Units GL) N=317 |
Placebo N=155 |
“Very satisfied” | 57% | 1% | 35% | 0% |
“Mostly satisfied” | 33% | 0% | 47% | 3% |
“Neither dissatisfied or satisfied” | 4% | 22% | 9% | 23% |
“Mostly dissatisfied” | 4% | 21% | 7% | 20% |
“Very dissatisfied” | 2% | 56% | 2% | 54% |
STUDY 1 | ||
---|---|---|
Responses | BOTOX Cosmetic (20 Units FHL with 20 Units GL) N=289 |
Placebo N=99 |
“Very satisfied” | 57% | 1% |
“Mostly satisfied” | 33% | 0% |
“Neither dissatisfied or satisfied” | 4% | 22% |
“Mostly dissatisfied” | 4% | 21% |
“Very dissatisfied” | 2% | 56% |
STUDY | ||
---|---|---|
Responses | BOTOX Cosmetic (20 Units FHL with 20 Units GL) N=317 |
Placebo N=155 |
“Very satisfied” | 35% | 0% |
“Mostly satisfied” | 47% | 3% |
“Neither dissatisfied or satisfied” | 9% | 23% |
“Mostly dissatisfied” | 7% | 20% |
“Very dissatisfied” | 2% | 54% |
Adverse reactions seen in
clinical studies1,2
- There were no additional adverse drug reactions reported with the simultaneous treatment of forehead lines, glabellar lines, and lateral canthal lines.1
Adverse reactions from BOTOX® Cosmetic forehead lines clinical studies1
Reactions | BOTOX® Cosmetic | Placebo |
---|---|---|
Headache | 9% (58/665) | 5% (17/315) |
Eyelid ptosis | 2% (12/665) | 0% (0/315) |
Brow ptosis | 2% (13/665) | 0% (0/315) |
Skin tightness | 2% (10/665) | 0% (0/315) |
References:
1. BOTOX® Cosmetic Prescribing Information, October 2017. 2. Data on file, Allergan; Clinical Study Report GMA-BTXC-12-001; March 11, 2014. 3. Data on file, Allergan; Clinical Study Report 191622-142; September 15, 2016. 4. Data on file, Allergan; Clinical Study Report 191622-143; September 19, 2016.