Glabellar Frown Lines and Canthal Lines and/or Horizontal Forehead Lines in the Upper Face
Conditions
Brief summary
This study is to collect long-term real-world evidence data from clinics in several countries in order to obtain an improved understanding of the safety and effectiveness of incobotulinumtoxinA in botulinum neurotoxin type A (BoNT-A) treatment naïve participants.
Interventions
IncobotulinumtoxinA injections for aesthetic indications.
Sponsors
Merz North America, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older. * Planning treatment with incobotulinumtoxinA.
Exclusion criteria
* Any contraindication to treatment with incobotulinumtoxinA or any other neurotoxins. * Currently pregnant, breastfeeding, or intending to become pregnant during study participation. * Known hypersensitivity to incobotulinumtoxinA or any of its formulation ingredients. * Any infection and/or inflammation at the planned injection points. * Previous treatment with any botulinum toxin products for any aesthetic or therapeutic indications.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of FACE-Q Patient-Perceived Age Visual Analogue Scale mean change | Up to 3 years | Explore the effectiveness of the incobotulinumtoxinA injections in treatment naïve participants for facial cosmetic procedures during up to 3 years continuous treatment exposure, as measured by assessment of FACE-Q Patient-Perceived Age Visual Analogue Scale mean change from first treatment visit to the 4-to-6 weeks timepoint. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of FACE-Q Satisfaction with Decision Scale mean change | Up to 3 years | Explore the effectiveness of the incobotulinumtoxinA injections in treatment naïve participants for facial cosmetic procedures during up to 3 years continuous treatment exposure, as measured by assessment of FACE-Q Satisfaction with Decision Scale mean change from first treatment visit to the 4-to-6 weeks timepoint. |
Countries
United States
Outcome results
None listed