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Clinical trial

LONG RUN: LONGitudinal Evaluation and Real-world Evidence of Uniquely Purified incobotulinumtoxinA (Xeomin) in Treatment Naïve Participants

ID
Name
M602011076
Description
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.
Trial arms
Trial start
2023-02-10
Estimated PCD
2023-05-18
Trial end
2023-05-18
Status
Terminated
Treatment
IncobotulinumtoxinA
IncobotulinumtoxinA injections for aesthetic indications.
Arms:
Facial treatment with incobotulinumtoxinA in treatment naïve participants
Other names:
XEOMIN®, BOCOUTURE®
Size
11
Primary endpoint
Assessment of FACE-Q Patient-Perceived Age Visual Analogue Scale mean change
Up to 3 years
Eligibility criteria
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.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_ONLY', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 11, 'type': 'ACTUAL'}}
Updated at
2023-06-07

1 organization

1 product

1 indication

Product
IncobotulinumtoxinA
Indication
Glabellar Frown Lines
Organization
Merz North America