- *Includes therapeutic and aesthetic uses.
- †Subject’s satisfaction and self-perception reported 3 weeks after treatment (n=531).
- ‡Design: Multicenter, prospective, non-interventional observational study conducted in France, Germany, Spain, and the United Kingdom (n=533). Subjects were eligible if the investigator had decided to prescribe Dysport according to the labeling. Subjects completed questionnaires at 3 weeks and 4 months after treatment.
- §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 GLSS improvement from baseline utilizing data from two double-blinded, randomized, placebo-controlled pivotal studies (GL-1, GL-3) in a post-hoc analysis.
- ¶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.
References
- Data on file. GL-Y-97-52120-085 (GL-2) Clinical Study Report. Fort Worth, TX: Galderma Laboratories, L.P., 2007.
- Data on file. GL-Y-97-52120-719 (GL-1) Clinical Study Report. Fort Worth, TX: Galderma Laboratories, L.P., 2007.
- Data on file. GL-Y-97-52120-718 (GL-3) Clinical Study Report. Fort Worth, TX: Galderma Laboratories, L.P., 2007.
- Data on file. MA-35497. Post Hoc Analysis. Fort Worth, TX: Galderma Laboratories, L.P., 2017.
- Data on file. Ipsen World-Wide Marketing Authorisation Status. Fort Worth, TX: Galderma Laboratories, L.P., February 2017.
- Medicines and Healthcare products Regulatory Agency (MHRA). Botulinum Toxin Type A Powder For Solution For Injection (Clostridium botulinum toxin type A – Haemagglutinin complex). Accessed December 6, 2019.
- Molina B, Grangier Y, Mole B, et al. Patient satisfaction after the treatment of glabellar lines with Botulinum toxin type A (Speywood Unit): a multi-centre European observational study. J Eur Acad Dermatol Venereol. 2015;29(7):1382-1388.
- Data on file. 43USD1802 Clinical Study Report. Fort Worth, TX: Galderma Laboratories, L.P., 2020.
DO NOT TAKE DYSPORT IF YOU:
- Are allergic to Dysport or any of the ingredients in Dysport. See the end of the Dysport Medication Guide for a list of ingredients in Dysport
- Are allergic to cow’s milk protein
- Had an allergic reaction to any other botulinum toxin product, such as Myobloc® (rimabotulinumtoxinB), Botox® (onabotulinumtoxinA) or Xeomin® (incobotulinumtoxinA)
- Have a skin infection at the planned injection site
DYSPORT MAY NOT BE RIGHT FOR YOU IF:
- You have had surgical changes to your face
- You have very weak muscles in the treatment area
- Your face looks very different from side to side
- The injection site is inflamed
- You have droopy eyelids or sagging eyelid folds
- You have deep facial scars
- You have thick, oily skin
- Your wrinkles can’t be smoothed by spreading them apart
The only way to know for sure if Dysport is right for you is to speak with your healthcare provider. Don’t have one? Find a specialist near you who administers Dysport.
See below for Dysport Important Safety Information, including Boxed Warning, and Medication Guide.