Phase 4
Completed N=250
The Treatment of Glabellar Frown Lines
Glabellar Frown Lines
Source: ClinicalTrials.gov NCT02096081 ↗
Enrolled (actual)
250
Serious AEs
0.8%
Results posted
Mar 2017
Primary outcomePrimary: Efficacy, Measured as the Percentage of Participants Who Responded to Treatment — 95.7; 99.2 percentage of participants
◆ Published Evidence
Established
48citations · ~4 / year
A Randomized, Double-Blind Trial to Investigate the Equivalence of IncobotulinumtoxinA and OnabotulinumtoxinA for Glabellar Frown Lines.
Summary
The purpose of this study is to show that two FDA-approved botulinum toxin drugs called Xeomin® and Botox® can reduce the severity of vertical lines (wrinkles) that appear between the eyebrows (glabellar frown lines).
Linked Publications
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A Randomized, Double-Blind Trial to Investigate the Equivalence of IncobotulinumtoxinA and OnabotulinumtoxinA for Glabellar Frown Lines.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy, Measured as the Percentage of Participants Who Responded to Treatment |
95.7; 99.2 | — |
| SECONDARY Response at Maximum Frown Rated by Independent Rater |
62.1; 67.2 | — |
| SECONDARY Response at Maximum Frown Rated by Treating Physician |
58.6; 60.5 | — |
| SECONDARY Subject Satisfaction |
107; 104; 8; 11; 1; 4 | — |
| SECONDARY Subject Perception of Treatment Onset |
3.0; 3.0 | — |
| SECONDARY Subject Perception of Treatment Peak Effect |
108; 113; 7; 4; 1; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Outpatient females 18 to 50 years of age
- Moderate to severe glabellar frown lines
Exclusion Criteria
- Glabellar Frown Lines at rest rating 3 on the 4-point Facial Wrinkle Scale
- Previous treatment with botulinum toxin
- Previous treatment with biodegradable fillers in glabellar area within last 12 months
- Any severe or uncontrolled systemic disease, malignant tumor, or medical history of HIV infection
- Known hypersensitivity to incobotulinumtoxinA or onabotulinumtoxinA or to any of their excipients
- Intake of any of the forbidden concomitant medication or other agents that might interfere with neuromuscular function or might interfere with the action of botulinum toxin type within 14 days prior to injection
Data sourced from ClinicalTrials.gov (NCT02096081) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.