CLINICAL STUDIES / UPPER FACIAL LINES

The original one
with simultaneous
treatment in
3 areas.1

For moderate to severe forehead lines, lateral canthal lines, and glabellar lines in adults.

Real BOTOX® Cosmetic patient.
Treated for the appearance of moderate to severe forehead lines, lateral canthal lines, and glabellar lines. Results may vary.

Predictable results with simultaneous treatment.1

Results in Forehead Line Trials

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 or moderate to severe forehead lines, lateral canthal lines, and glabellar lines simultaneously.1

Primary End Point at Day 301

Responder rate of subjects achieving ≥ 2-grade improvement from baseline: Composite investigator and patient assessment of forehead line severity at maximum eyebrow elevation using the 4-point facial wrinkle scale with photonumeric guide (FWS) at 
day 30 following the first treatment.1

StudyBOTOX® Cosmetic
(40 Units: 20U FHL + 20U GL)		BOTOX® Cosmetic
(64 Units: 20U FHL + 24U LCL + 20U GL)		PlaceboP Value
Study 161% (178/290)–0% (0/101)P < .0001
Study 246% (145/318)53% (166/313)1% (1/156)P < .0001

FHL = forehead lines; GL = glabellar lines; LCL = lateral canthal lines.

Secondary End Point1

Investigator-assessed achievement of none or mild forehead lines from baseline on FWS at maximum eyebrow elevation (treatment success) in Study 2.1

Results lasted up to 4 months in 3 areas1,2

Patient satisfaction with simultaneous treatment.1-3

90%

In Study 1 of the forehead lines trials, 90% of patients (n = 289) reported being "Very Satisfied" or "Mostly Satisfied" with BOTOX® Cosmetic when treated in 2 areas: moderate to severe forehead lines and glabellar lines, compared to 1% (n = 99) with placebo.1

82%

In Study 2 of the forehead lines trials, 82% of patients (n = 317) reported being “Very Satisfied” or “Mostly Satisfied” with BOTOX® Cosmetic when treated in 2 areas: moderate to severe forehead lines and glabellar lines, compared to 3% (n = 155) with placebo.1

88%

In Study 2 of the forehead lines trials, 88% of patients (n = 313) reported being “Very Satisfied” or “Mostly Satisfied” with BOTOX® Cosmetic when treated in 3 areas: moderate to severe forehead lines, lateral canthal lines, and glabellar lines, compared to 3% (n = 156) with placebo.2

Patients are satisfied when treated in all 3 areas

BOTOX® Cosmetic patients had satisfaction rates over time when treated in 3 areas compared to patients treated in 2 areas or with placebo.3,*

*Based on patients in Study 2 who reported being “Very Satisfied” or “Mostly Satisfied” with their treatment in the forehead line trials. In treatment cycle 1, patients were randomized to receive 64 Units of BOTOX® Cosmetic treatment, 40 Units of BOTOX® Cosmetic treatment, or placebo. Responder rates for satisfaction were taken at week 1, week 2, day 30, day 60, day 90, day 120, day 150, and day 180.3,*

Patients in the forehead line trials completed a Facial Line Satisfaction Questionnaire (FLSQ) at day 60 and were asked how satisfied they were with their BOTOX® Cosmetic treatment on a 5-point scale with the following responses: ”Very Satisfied,”
”Mostly Satisfied,” ”Neither Satisfied or Dissatisfied,” ”Mostly Dissatisfied,” and “Very Dissatisfied.”

Consistent, repeatable results with simultaneous treatment.1

The response rate for forehead lines was similar across all 
3 treatment cycles.1

A total of 165 and 197 patients received 3 cycles of BOTOX® Cosmetic over 1 year: 40 Units (20U FHL + 20U GL) and 64 Units (20U FHL + 24U LCL + 20U GL), respectively.1 Responders were defined as patients achieving ≥ 2-grade composite improvement from baseline on investigator and subject FWS ratings of forehead line severity at maximum eyebrow elevation.1

Patient Response With Repeat Treatment in 3 Areas1,2

In forehead line clinical trials, all patients were treated in 3 areas with 64 Units in cycles 2 and 3, and with subsequent treatment cycles, results did not return to baseline levels.1,2

Responders Achieving ≥ 2-Grade Composite Improvement From Baseline on Investigator and Subject FWS Ratings of Forehead Line Severity at Maximum Eyebrow Elevation (ITT Population)1,2

Adverse reactions seen in forehead lines studies1

ReactionsBOTOX® Cosmetic (n = 665)

Placebo (n = 315)

Headache9% (58/665)5% (17/315)
Eyelid ptosis2% (12/665)0% (1/315)
Brow ptosis2% (13/665)0% (0/315)
Skin tightness2% (10/665)0% (0/315)

There were no additional adverse drug reactions reported with the simultaneous treatment of moderate to severe forehead lines, lateral canthal lines, and glabellar lines.1

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Real BOTOX® Cosmetic patient.

Treated for the appearance of moderate to severe forehead lines, lateral canthal lines, and glabellar lines. Results may vary.

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BOTOX® Cosmetic IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING

BOTOX® Cosmetic (onabotulinumtoxinA) Important Information

Indications

BOTOX® Cosmetic (onabotulinumtoxinA) is indicated in adult patients for the temporary improvement in the appearance of:

- Moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity

- Moderate to severe lateral canthal lines associated with orbicularis oculi activity

- Moderate to severe forehead lines associated with frontalis activity

- Moderate to severe platysma bands associated with platysma muscle activity


BOTOX® Cosmetic IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING

WARNING: DISTANT SPREAD OF TOXIN EFFECT

Postmarketing reports indicate that the effects of BOTOX® Cosmetic and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity, but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have an underlying condition that would predispose them to these symptoms. In unapproved uses and approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and spasticity and at lower doses.

CONTRAINDICATIONS

BOTOX® Cosmetic is contraindicated in the presence of infection at the proposed injection site(s) and in individuals with known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation.

WARNINGS AND PRECAUTIONS
Lack of Equivalency Between Botulinum Toxin Products
The potency Units of BOTOX® Cosmetic are specific to the preparation and assay method utilized. BOTOX® Cosmetic is not equivalent to other preparations of botulinum toxin products, and therefore, Units of biological activity of BOTOX® Cosmetic cannot be compared to nor converted into Units of any other botulinum toxin products assessed with any other specific assay method.

Spread of Toxin Effect
Please refer to Boxed Warning for Distant Spread of Toxin Effect.

No definitive serious adverse event reports of distant spread of toxin effect associated with dermatologic use of BOTOX® Cosmetic at the labeled dose of 20 Units (for glabellar lines), 24 Units (for lateral canthal lines), 40 Units (for forehead lines with glabellar lines), 44 Units (for simultaneous treatment of lateral canthal lines and glabellar lines), and 64 Units (for simultaneous treatment of lateral canthal lines, glabellar lines, and forehead lines) have been reported. Patients or caregivers should be advised to seek immediate medical care if swallowing, speech, or respiratory disorders occur.

Serious Adverse Reactions With Unapproved Use

Serious adverse reactions, including excessive weakness, dysphagia, and aspiration pneumonia, with some adverse reactions associated with fatal outcomes, have been reported in patients who received BOTOX® injections for unapproved uses. In these cases, the adverse reactions were not necessarily related to distant spread of toxin, but may have resulted from the administration of BOTOX® to the site of injection and/or adjacent structures. In several of the cases, patients had preexisting dysphagia or other significant disabilities. There is insufficient information to identify factors associated with an increased risk for adverse reactions associated with the unapproved uses of BOTOX®. The safety and effectiveness of BOTOX® for unapproved uses have not been established.

Hypersensitivity Reactions

Serious and/or immediate hypersensitivity reactions have been reported. These reactions include anaphylaxis, serum sickness, urticaria, soft-tissue edema, and dyspnea. If such a reaction occurs, discontinue further injection of BOTOX® Cosmetic and immediately institute appropriate medical therapy. One fatal case of anaphylaxis has been reported in which lidocaine was used as the diluent and, consequently, the causal agent cannot be reliably determined.

Cardiovascular System

There have been reports following administration of BOTOX® of adverse events involving the cardiovascular system, including arrhythmia and myocardial infarction, some with fatal outcomes. Some of these patients had risk factors, including preexisting cardiovascular disease. Use caution when administering to patients with preexisting cardiovascular disease.

Increased Risk of Clinically Significant Effects With Preexisting Neuromuscular Disorders

Patients with neuromuscular disorders may be at increased risk of clinically significant effects, including generalized muscle weakness, diplopia, ptosis, dysphonia, dysarthria, severe dysphagia, and respiratory compromise from onabotulinumtoxinA (see Warnings and Precautions). Monitor individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis or neuromuscular junction disorders (eg, myasthenia gravis or Lambert-Eaton syndrome) when given botulinum toxin.

Dysphagia and Breathing Difficulties

Treatment with BOTOX® and other botulinum toxin products can result in swallowing or breathing difficulties. Patients with preexisting swallowing or breathing difficulties may be more susceptible to these complications. In most cases, this is a consequence of weakening of muscles in the area of injection that are involved in breathing or oropharyngeal muscles that control swallowing or breathing (see Boxed Warning). 

Preexisting Conditions at the Injection Site

Use caution when BOTOX® Cosmetic treatment is used in the presence of inflammation at the proposed injection site(s) or when excessive weakness or atrophy is present in the target muscle(s). 

Dry Eye in Patients Treated With BOTOX® Cosmetic

There have been reports of dry eye associated with BOTOX® Cosmetic injection in or near the orbicularis oculi muscle. If symptoms of dry eye (eg, eye irritation, photophobia, or visual changes) persist, consider referring patients to an ophthalmologist.

Human Albumin and Transmission of Viral Diseases

This product contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries a remote risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD). There is a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD), which would also be considered remote. No cases of transmission of viral diseases, CJD, or vCJD have ever been identified for licensed albumin or albumin contained in other licensed products.

ADVERSE REACTIONS

The most frequently reported adverse reactions following injection of BOTOX® Cosmetic for glabellar lines were eyelid ptosis (3%), facial pain (1%), facial paresis (1%), and muscular weakness (1%).


The most frequently reported adverse reaction following injection of BOTOX® Cosmetic for lateral canthal lines was eyelid edema (1%).


The most frequently reported adverse reactions following injection of BOTOX® Cosmetic for forehead lines with glabellar lines were headache (9%), brow ptosis (2%), and eyelid ptosis (2%).


The safety profile of BOTOX® Cosmetic treatment of platysma bands is consistent with the known safety profile of BOTOX® Cosmetic for other indications.



DRUG INTERACTIONS

Coadministration of BOTOX® Cosmetic and aminoglycosides or other agents interfering with neuromuscular transmission (eg, curare-like compounds) should only be performed with caution as the effect of the toxin may be potentiated. Use of anticholinergic drugs after administration of BOTOX® Cosmetic may potentiate systemic anticholinergic effects.


The effect of administering different botulinum neurotoxin products at the same time or within several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin.


Excessive weakness may also be exaggerated by administration of a muscle relaxant before or after administration of BOTOX® Cosmetic.


USE IN SPECIFIC POPULATIONS

There are no studies or adequate data from postmarketing surveillance on the developmental risk associated with use of BOTOX® Cosmetic in pregnant women. There are no data on the presence of BOTOX® Cosmetic in human or animal milk, the effects on the breastfed child, or the effects on milk production.


Please see BOTOX® Cosmetic full Prescribing Information, including Boxed Warning and Medication Guide.

BOTOX® Cosmetic (onabotulinumtoxinA) Important Information

Indications

BOTOX® Cosmetic (onabotulinumtoxinA) is indicated in adult patients for the temporary improvement in the appearance of:

- Moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity

- Moderate to severe lateral canthal lines associated with orbicularis oculi activity

- Moderate to severe forehead lines associated with frontalis activity

- Moderate to severe platysma bands associated with platysma muscle activity


BOTOX® Cosmetic IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING

WARNING: DISTANT SPREAD OF TOXIN EFFECT

Postmarketing reports indicate that the effects of BOTOX® Cosmetic and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity, but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have an underlying condition that would predispose them to these symptoms. In unapproved uses and approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and spasticity and at lower doses.

CONTRAINDICATIONS

BOTOX® Cosmetic is contraindicated in the presence of infection at the proposed injection site(s) and in individuals with known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation.

WARNINGS AND PRECAUTIONS
Lack of Equivalency Between Botulinum Toxin Products
The potency Units of BOTOX® Cosmetic are specific to the preparation and assay method utilized. BOTOX® Cosmetic is not equivalent to other preparations of botulinum toxin products, and therefore, Units of biological activity of BOTOX® Cosmetic cannot be compared to nor converted into Units of any other botulinum toxin products assessed with any other specific assay method.

Spread of Toxin Effect
Please refer to Boxed Warning for Distant Spread of Toxin Effect.

No definitive serious adverse event reports of distant spread of toxin effect associated with dermatologic use of BOTOX® Cosmetic at the labeled dose of 20 Units (for glabellar lines), 24 Units (for lateral canthal lines), 40 Units (for forehead lines with glabellar lines), 44 Units (for simultaneous treatment of lateral canthal lines and glabellar lines), and 64 Units (for simultaneous treatment of lateral canthal lines, glabellar lines, and forehead lines) have been reported. Patients or caregivers should be advised to seek immediate medical care if swallowing, speech, or respiratory disorders occur.

Serious Adverse Reactions With Unapproved Use

Serious adverse reactions, including excessive weakness, dysphagia, and aspiration pneumonia, with some adverse reactions associated with fatal outcomes, have been reported in patients who received BOTOX® injections for unapproved uses. In these cases, the adverse reactions were not necessarily related to distant spread of toxin, but may have resulted from the administration of BOTOX® to the site of injection and/or adjacent structures. In several of the cases, patients had preexisting dysphagia or other significant disabilities. There is insufficient information to identify factors associated with an increased risk for adverse reactions associated with the unapproved uses of BOTOX®. The safety and effectiveness of BOTOX® for unapproved uses have not been established.

Hypersensitivity Reactions

Serious and/or immediate hypersensitivity reactions have been reported. These reactions include anaphylaxis, serum sickness, urticaria, soft-tissue edema, and dyspnea. If such a reaction occurs, discontinue further injection of BOTOX® Cosmetic and immediately institute appropriate medical therapy. One fatal case of anaphylaxis has been reported in which lidocaine was used as the diluent and, consequently, the causal agent cannot be reliably determined.

Cardiovascular System

There have been reports following administration of BOTOX® of adverse events involving the cardiovascular system, including arrhythmia and myocardial infarction, some with fatal outcomes. Some of these patients had risk factors, including preexisting cardiovascular disease. Use caution when administering to patients with preexisting cardiovascular disease.

Increased Risk of Clinically Significant Effects With Preexisting Neuromuscular Disorders

Patients with neuromuscular disorders may be at increased risk of clinically significant effects, including generalized muscle weakness, diplopia, ptosis, dysphonia, dysarthria, severe dysphagia, and respiratory compromise from onabotulinumtoxinA (see Warnings and Precautions). Monitor individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis or neuromuscular junction disorders (eg, myasthenia gravis or Lambert-Eaton syndrome) when given botulinum toxin.

Dysphagia and Breathing Difficulties

Treatment with BOTOX® and other botulinum toxin products can result in swallowing or breathing difficulties. Patients with preexisting swallowing or breathing difficulties may be more susceptible to these complications. In most cases, this is a consequence of weakening of muscles in the area of injection that are involved in breathing or oropharyngeal muscles that control swallowing or breathing (see Boxed Warning). 

Preexisting Conditions at the Injection Site

Use caution when BOTOX® Cosmetic treatment is used in the presence of inflammation at the proposed injection site(s) or when excessive weakness or atrophy is present in the target muscle(s). 

Dry Eye in Patients Treated With BOTOX® Cosmetic

There have been reports of dry eye associated with BOTOX® Cosmetic injection in or near the orbicularis oculi muscle. If symptoms of dry eye (eg, eye irritation, photophobia, or visual changes) persist, consider referring patients to an ophthalmologist.

Human Albumin and Transmission of Viral Diseases

This product contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries a remote risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD). There is a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD), which would also be considered remote. No cases of transmission of viral diseases, CJD, or vCJD have ever been identified for licensed albumin or albumin contained in other licensed products.

ADVERSE REACTIONS

The most frequently reported adverse reactions following injection of BOTOX® Cosmetic for glabellar lines were eyelid ptosis (3%), facial pain (1%), facial paresis (1%), and muscular weakness (1%).


The most frequently reported adverse reaction following injection of BOTOX® Cosmetic for lateral canthal lines was eyelid edema (1%).


The most frequently reported adverse reactions following injection of BOTOX® Cosmetic for forehead lines with glabellar lines were headache (9%), brow ptosis (2%), and eyelid ptosis (2%).


The safety profile of BOTOX® Cosmetic treatment of platysma bands is consistent with the known safety profile of BOTOX® Cosmetic for other indications.



DRUG INTERACTIONS

Coadministration of BOTOX® Cosmetic and aminoglycosides or other agents interfering with neuromuscular transmission (eg, curare-like compounds) should only be performed with caution as the effect of the toxin may be potentiated. Use of anticholinergic drugs after administration of BOTOX® Cosmetic may potentiate systemic anticholinergic effects.


The effect of administering different botulinum neurotoxin products at the same time or within several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin.


Excessive weakness may also be exaggerated by administration of a muscle relaxant before or after administration of BOTOX® Cosmetic.


USE IN SPECIFIC POPULATIONS

There are no studies or adequate data from postmarketing surveillance on the developmental risk associated with use of BOTOX® Cosmetic in pregnant women. There are no data on the presence of BOTOX® Cosmetic in human or animal milk, the effects on the breastfed child, or the effects on milk production.


Please see BOTOX® Cosmetic full Prescribing Information, including Boxed Warning and Medication Guide.

References: 1. BOTOX® Cosmetic Prescribing Information, October 2024. 2. Data on file, Allergan, September 19, 2016; Clinical Study Report. 3. Data on file, Allergan, 2016; Clinical Study Report Satisfaction Table.

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