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the only one FDA approved for simultaneous treatment in 3 areas2,4-6
BOTOX® Cosmetic (onabotulinumtoxinA) has clinical data
reported in 528 aesthetic publications—that’s more than any other product of its kind.8
You can see our pivotal studies below.
PRIMARY EFFICACY END POINT: Composite investigator and subject assessment of forehead line severity at maximum eyebrow elevation at day 30-responder rates (% and number of subjects achieving a ≥ 2-grade improvement on Facial Wrinkle Scale [FWS] from baseline)2
Study | BOTOX® Cosmetic (40 Units: 20U FHL + 20U GL) | BOTOX® Cosmetic (64 Units: 20U FHL + 20U GL + 24U LCL) | Placebo | P-Value |
---|---|---|---|---|
Study 1 | 61% (178/290) | - | 0% (0/101) | P < 0.0001 |
Study 2 | 46% (145/318) | 53% (166/318) | 1% (1/156) | P < 0.0001 |
FHL = forehead lines; GL = glabellar lines; LCL = lateral canthal lines.
SECONDARY EFFICACY END POINT: Investigator-assessed achievement of none or mild from baseline on FWS at maximum eyebrow elevation (treatment success)2
Study 1
Study 2
FHL = forehead lines; GL = glabellar lines; LCL = lateral canthal lines.
Two pivotal, multicenter, randomized, double-blind, placebo-controlled studies with 1178 patients (921 received BOTOX® Cosmetic) treated for moderate to severe forehead lines and glabellar lines simultaneously or moderate to severe forehead lines, glabellar lines, and lateral canthal lines simultaneously. The primary end point was investigator and patient assessment of forehead line severity at maximum eyebrow elevation using the 4-point FWS with Photonumeric Guide at day 30 following the first treatment.2
SIMILAR RESULTS FOR FOREHEAD LINES2
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.2
BOTOX® COSMETIC PROVIDES PATIENT SATISFACTION2
of subjects in Study 1 reported being "Very Satisfied" or "Mostly Satisfied" with BOTOX® Cosmetic compared to 1% with placebo at day 602
of subjects in Study 2 reported being "Very Satisfied" or "Mostly Satisfied" with BOTOX® Cosmetic compared to 3% with placebo at day 602
FACIAL LINES SATISFACTION QUESTIONNAIRE RESPONSE FREQUENCY AT DAY 60 (% OF SUBJECTS)2 | ||||
Study1 | Study2 | |||
Responses | BOTOX® Cosmetic (20U FHL + 20U GL; N = 289) | Placebo (N = 99) | BOTOX® Cosmetic (20U FHL + 20U GL; N = 317) | Placebo (N = 155) |
"Very Satisfied" | 57%90% | 1% | 35%82% | 0% |
"Mostly Satisfied" | 33% | 0% | 47% | 3% |
"Neither Dissatisfied | 4% | 22% | 9% | 23% |
"Mostly Dissatisfied" | 4% | 21% | 7% | 20% |
"Very Dissatitsfied" | 2% | 56% | 2% | 54% |
FHL = forehead lines; GL = glabellar lines.
ADVERSE REACTIONS FROM BOTOX® COSMETIC FOREHEAD LINES CLINICAL STUDIES2
Reactions | BOTOX® Cosmetic (N = 665) | PLACEBO (N = 315) |
---|---|---|
Headache | 9% (58/665) | 5% (17/315) |
Eyelid ptosis | 2% (12/665) | 0% (1/315) |
Brow ptosis | 2% (13/665) | 0% (0/315) |
Skin tightness | 2% (10/665) | 0% (0/315) |
There were no additional adverse drug reactions reported with the simultaneous treatment of forehead lines, lateral canthal lines, and glabellar lines.2
Forehead lines studies: Study 1 assessed BOTOX® Cosmetic treatment of forehead lines with glabellar lines; Study 2 assessed simultaneous treatment of forehead lines, lateral canthal lines, and glabellar lines.2
PRIMARY EFFICACY END POINT: Composite investigator and subject assessment of lateral canthal line severity at maximum smile at day 30-responder rates (% and number of subjects achieving a ≥ 2-grade improvement on Facial Wrinkle Scale [FWS] from baseline)2
Study | BOTOX® Cosmetic (24 Units LCL) | BOTOX® Cosmetic (44 Units: 24U LCL + 20U GL) | Placebo |
---|---|---|---|
Study 1 | 26.1% (58/222) | - | 1.3% (3/223) |
Study 2 | 20.3% (62/306) | 21.3% (65/305) | 0% (0/306) |
LCL = lateral canthal lines; GL = glabellar lines.
SECONDARY EFFICACY END POINT: Investigator-assessed achievement of none or mild from baseline on FWS in Study 1 (treatment success)2
Study 1
Two pivotal, multicenter, randomized, double-blind, placebo-controlled studies with 1362 patients (833 received BOTOX® Cosmetic) treated for moderate to severe lateral canthal lines or simultaneously with glabellar linesâ with 305 also injected for their moderate to severe glabellar lines. The primary end point was investigator and patient assessment of lateral canthal line severity at maximum smile using the 4-point FWS with Photonumeric Guide at day 30 following the first treatment.2
ADVERSE REACTION FROM BOTOX® COSMETIC LATERAL CANTHAL LINES CLINICAL STUDIES2
Event | BOTOX® Cosmetic (N = 526) | Placebo (N = 530) |
---|---|---|
Eyelid edema | 1% (5/526) | 0% (0/530) |
Lateral canthal lines studies: Study 1 assessed BOTOX® Cosmetic treatment of LCL alone; Study 2 assessed simultaneous treatment of lateral canthal lines and glabellar lines.2
CO-PRIMARY EFFICACY END POINTS: Investigator’s rating of glabellar line severity at maximum frown (responder: severity grade of none or mild) and subject’s global assessment of change in appearance of glabellar lines (responder: grade of at least a + 2 [moderate improvement]), both at day 30 vs baseline2
2 DAYS
(48 HOURS)
QUICK
RESPONSE2
Patients may begin to see results within 24 to 48 hours after injection in glabellar lines2
DAY
7
REAL RESULTS AS EARLY AS DAY 72
Investigator: 74% (299/405)
vs 6% (8/132) for placebo2
Subject: 82% (334/405)
vs 9% (12/132) for placebo2
DAY
30
SIGNIFICANT RESPONSE AT DAY 302
Investigator: 80% (325/405)
vs 3% (4/132) for placebo2
Subject: 89% (362/405)
vs 7% (9/132) for placebo2
MONTH
4
LONG-LASTING
RESULTS2
Investigator: 25% (102/403)
vs 2% (2/128) for placebo2
Subject: 39% (157/403)
vs 1% (1/128) for placebo2
Two pivotal, multicenter, randomized, double-blind, placebo-controlled studies with 537 patients (405 received BOTOX® Cosmetic) treated for moderate to severe glabellar lines. The co-primary end points were the investigator's rating of glabellar line severity at maximum frown and the subject's global assessment of change in appearance of glabellar lines, both at day 30 post injection.2
BOTOX® COSMETIC PROVIDES PATIENT SATISFACTION9
of subjects in a clinical study were ″Satisfied″ with their glabellar line results compared to 0% placebo (P < 0.001)9
FACIAL LINES SATISFACTION QUESTIONNAIRE: FOLLOW-UP VERSION (LCL AND GL) AT DAY 60 (% of subjects) | ||
---|---|---|
Responses | BOTOX® Cosmetic (44 Units: 24U LCL + 20U GL; N = 60) | Placebo (N = 57) |
"Satisfied" | 82% | 0% |
"Not Satisfied" | 18% | 100% |
LCL = lateral canthal lines; GL = glabellar lines.
A multicenter, randomized, double-blind, placebo-controlled, parallel-group, 120-day study of satisfaction with BOTOX® Cosmetic treatment in subjects with moderate or severe glabellar lines and lateral canthal lines. Primary end point was the between-group difference in the proportion of responders on the Facial Wrinkle Scale (per-protocol patient population). Response was defined as subjects answering “Mostly satisfied” or “Very satisfied” on item #5 of the Facial Line Satisfaction Questionnaire (FLSQ) at day 60 (glabellar lines only, follow-up version).9
ADVERSE REACTIONS FROM BOTOX® COSMETIC GLABELLAR LINES CLINICAL STUDIES2
Event | BOTOX® Cosmetic (N = 405) | Placebo (N = 130) |
---|---|---|
Eyelid ptosis | 3% (13/405) | 0% (0/130) |
Facial pain | 1% (6/405) | 0% (0/130) |
Facial paresis | 1% (5/405) | 0% (0/130) |
Muscular weakness | 1% (6/405) | 0% (0/130) |
Glabellar lines studies: Two phase 3 trials of identical design assessed treatment of glabellar lines alone.2
There’s nothing else like BOTOX® Cosmetic (onabotulinumtoxinA); it’s impossible to exactly replicate. This is because critical quality attributes define the complex fingerprint of a biologic such as BOTOX®.2,10 Just as no two fingerprints are the same, no two neurotoxins are the same.10,11
BOTOX® Cosmetic is the result of a unique and proprietary manufacturing process, where Allergan Aesthetics owns the entire development, production, and distribution system from start to finish.2,12-14
Our unique manufacturing process means you can’t convert units from BOTOX® Cosmetic. There’s no dose ratio between neurotoxin products.2
100 Units
50 Units
50-Unit sample
REFERENCES: 1. BOTOX® Prescribing Information, February 2021. 2. BOTOX® CosmeticPrescribing Information, July 2020. 3. Data on file, Allergan, FDA Product Approval Information. 4. Dysport® Prescribing Information, July 2020. 5. Xeomin® Prescribing Information, August 2020. 6. Jeuveau® Prescribing Information, January 2020. 7. Data on file, Allergan, February 21, 2019, Total Number of Vials Produced at Westport. 8. Data on file, Allergan, November 2018, Botulinum Toxin Peer-Reviewed Publications. 9. Data on file, Allergan; March 11, 2014; Clinical Study Report GMA-BTXC-12-001. 10. US Food and Drug Administration. Frequently asked questions about therapeutic biological products. US Food and Drug Administration website. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm113522.htm. Updated July 7, 2015. Accessed May 1, 2022. 11. Vulto AG, Jaquez OA. The process defines the product: what really matters in biosimilar design and production? Rheumatology (Oxford). 2017;56(suppl 4):iv14-iv29. 12. Data on file, Allergan, October 29, 2020; Westport Manufacturing Process. 13. Brin MF, James C, Maltman J. Botulinum toxin type A products are not interchangeable: a review of the evidence. Biologics. 2014;8:227-241. 14. Samizadeh S, De Boulle K. Botulinum neurotoxin formulations: overcoming the confusion. Investig Dermatol. 2018;11:273-287.