FOR HEALTHCARE PROFESSIONALS

Dysport® (abobotulinumtoxinA) for injection is an acetylcholine release inhibitor and neuromuscular blocking agent indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with procerus and corrugator muscle activity in adult patients less than 65 years of age.

Lily, 35, Actual Dysport User.
Individual results may vary.

Dysport Clinical Study Results

Meaningful efficacy that’s rapid and enduring

More than half of subjects saw improvement in as little as 2-3 days after treatment1-3* and results may last up to 5 months.2-4† In clinical trials, overall treatment success required at least a 2-grade improvement from baseline by both investigator and subject assessments.

Fast-Acting

Line Fast Acting
Over half of users see improvment 2‐3 days after Dysport® injection for
                                         frown lines between the brows

Over half of users see improvement 2-3 days after treatment.1-3*

Long-Lasting

Line Long Lasting
Long‐lasting: Dysport® injection results (smoother frown lines between
                                         the brows) may last up to 5 months

Results may last up to
5 months.2-4†

*A secondary endpoint based on Kaplan-Meier estimates of cumulative rate of time to onset of response. The median time to onset of response was 3 days in GL-1 (Dysport 55/105 [52%], Placebo 3/53 [6%] and GL-2 (Dysport 36/71 [51%], Placebo 9/71 [13%]), and 2 days in GL-3 (Dysport 110/200 [55%], Placebo 4/100 [4%]).

GL-1 and GL-3 evaluated subjects for at least 150 days following treatment. Based on a ≥1-Grade glabellar line severity scale (GLSS) improvement from baseline utilizing data from two double-blinded, randomized, placebo-controlled pivotal studies (GL-1, GL-3) in a post-hoc analysis.

  • Success was defined as post-treatment glabellar line severity of none or mild for the combined investigator and subject assessments (composite assessment) on Day 30 with at least a 2-grade improvement.4 The following scale was used to assess efficacy at maximum frown: 0 none, 1 mild, 2 moderate, 3 severe.
  • A subject had to improve from a score of 3 (severe) to a score of 1 or 0 (mild or none), or a score of 2 (moderate) to a score of 0 (none) in order to meet the requirements for overall treatment success.

Three double-blind, randomized, placebo-controlled clinical studies evaluated the efficacy of Dysport® for use in the temporary improvement of the appearance of moderate to severe glabellar lines. These 3 studies enrolled healthy adults (ages 19–75) with glabellar lines of at least moderate severity at maximum frown. Subjects were excluded if they had marked ptosis, deep dermal scarring, or a substantial inability to lessen glabellar lines, even by physically spreading them apart. The subjects in these studies received either Dysport or placebo. The total dose was 50 units delivered in equally divided aliquots to specified injection sites.

Additional endpoints for each of the studies were post-treatment glabellar line severity of none or mild with at least a 1-grade improvement from baseline for separate investigator and subject assessments at Day 30.

  • Studies GL-1 and GL-3 were 6- and 5-month (respectively) single-dose studies comparing Dysport to placebo
  • GL-2 was a study of Dysport vs placebo in subjects who had received up to 4 treatments of Dysport over the course of the study

Pivotal study demonstrated improvement after treatment2

The GL-1 study was a 6-month, single-dose, double-blind, multicenter, randomized, placebo-controlled study (N=158) to assess the safety and efficacy of 50 Units of Dysport vs placebo in subjects with moderate to severe glabellar lines at maximum frown.2 55 percent (58/105 Dysport subjects vs 0/53 treated with placebo) met the primary endpoint.

Investigator and
                 subject assessed responder rates (GLSS Score of 0 or 1) in glabellar lines severity at maximum frown

Long-lasting 5-month clinical effect2-4

GL‐1 and GL‐3 evaluated subjects for at least 150 days following treatment.
                 Based on a ≥1‐Grade GLSS improvement from baseline utilizing data from two double‐blinded, randomized, placebo‐controlled pivotal studies (GL‐1, GL‐3) in a post‐hoc analysis

GL-1 and GL-3 evaluated subjects for at least 150 days following treatment. Based on a ≥1-Grade GLSS improvement from baseline utilizing data from two double-blinded, randomized, placebo-controlled pivotal studies (GL-1, GL-3) in a post-hoc analysis.

User§ satisfaction that lasts

98%

of users§ wanted to use Dysport again after only 2 treatments.5‖

95%

of both toxin naïve and non-toxin-naïve users§ were satisfied with 2 treatments per year, 6 months apart.5‖

97%

of users§ thought their results looked natural 6 months after treatment.5‖

MORE THAN
95%

of users§ felt confident, attractive, and happy 1 month after treatment.5‖¶

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  • §Users = clinical trial subjects.
  • Subject-reported at 12 months (N=120) after two treatments six months apart in a phase IV, multicenter, prospective study.
  • 3 out of 10 FACE-Q questions about psychological function are shown.

The DREAM study was a multicenter, open-label, interventional study to evaluate subject satisfaction after two treatments with 50 Units of Dysport every six months (twice yearly) in the glabella in subjects with moderate to severe glabellar lines at maximum frown. In this study, 120 subjects were enrolled ages 18-65 (mean 43.8 years), 90% female, and 33% were toxin-naïve. Subjects had a baseline GLSS score of moderate (2) or severe (3) as assessed by investigator and subject at maximum frown and had no botulinum toxin treatment in the face within 9 months prior. The primary objective of the study was patient satisfaction, assessed by directly questioning subjects and giving them the option of responding with "highly satisfied," "satisfied," "dissatisfied," or "highly dissatisfied” at 12 months. Secondary objectives included patient satisfaction as assessed by subject satisfaction questionnaire and the FACE-Q scales measuring subject's psychological function and appraisal of lines between the eyebrows; efficacy and onset of effect both assessed by subject self-assessment (SSA) and investigator live-assessment (ILA) using a 4-point GLSS scale and safety.5

Most common side effects

As with any botulinum toxin type A treatment, the most common side effects are nose and throat irritation, headache, injection site pain, injection site skin reaction, upper respiratory tract infection, eyelid swelling, eyelid drooping, sinus inflammation and nausea. See below for complete Important Safety Information.

Before + After

Actual patients. Results unretouched.

Identifying Authentic Dysport®

The best way to protect your patients from counterfeit Dysport is to verify that you’re ordering authentic Dysport from an authorized distributor. Be sure to check the packaging of your product to make sure it’s authentic.

There are more anti-counterfeiting measures on the packaging that aren’t listed here. Ask your distributor for more information.


Administering & Reconstitution

Dosing for moderate to severe glabellar lines

Watch to learn more about administering and reconstituting Dysport.

Download the Dysport Reconstitution Guide

Looking for information on injecting Dysport?

Visit GAINHCP.com to register and learn more about injection techniques and training.

Find a specialist for frown line between the brows treatment with Dysport®

Find a Specialist Feature

The Find a Specialist feature on DysportUSA.com makes it easy for website visitors to locate and contact you regarding aesthetic treatment. All you have to do to remain listed on the Dysport Find a Specialist feature is place an order for Dysport a minimum of every six months.

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Have Questions? Contact Galderma.

If you would like to place an order for Dysport or have any related product questions, please call 1-844-GALDERM (1-844-425-3376) to speak with a sales representative or email customer service at ContactUs@GaldermaSupport.com.

For any medical inquiries, including reporting adverse medical reactions to a Galderma product, please call 1-866-735-4137 or email customer service at ContactUs@GaldermaSupport.com.

References
  1. Data on file. MA-Y-97-52120-085 (GL-2) Clinical Study Report. Fort Worth, TX: Galderma Laboratories, L.P., 2007.
  2. Data on file. GL-Y-97-52120-719 (GL-1) Clinical Study Report. Fort Worth, TX: Galderma Laboratories, L.P., 2007.
  3. Data on file. GL-Y-97-52120-718 (GL-3) Clinical Study Report. Fort Worth, TX: Galderma Laboratories, L.P., 2007.
  4. Data on file. MA-35497. Post Hoc Analysis. Fort Worth, TX: Galderma Laboratories, L.P., 2017.
  5. Data on file. 43USD1802 Clinical Study Report. Fort Worth, TX: Galderma Laboratories, L.P., 2020.

Dysport® (abobotulinumtoxinA) for Injection is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with procerus and corrugator muscle activity in adults < 65 years of age.

IMPORTANT SAFETY INFORMATION DISTANT SPREAD OF TOXIN EFFECT

Postmarketing reports indicate that the effects of Dysport 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, blurred vision, 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 underlying conditions that would predispose them to these symptoms. In unapproved uses and in approved indications, cases of spread of effect have been reported at doses comparable to or lower than the maximum recommended total dose.

Contraindications

Warnings and Precautions

Adverse Reaction

Drug Interactions

Use in Specific Populations

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see Dysport Full Prescribing Information, including Medication Guide at DysportUSA.com.

MEDICATION GUIDE

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