Phase 4
Completed N=224
Safety and Efficacy of Two Types of Botulinum Toxin Type A For the Treatment of Glabellar Lines
Glabellar Lines
Source: ClinicalTrials.gov NCT01271452 ↗
Enrolled (actual)
224
Serious AEs
0.0%
Results posted
Jan 2012
Primary outcomePrimary: Number of Subjects With a Treatment Response at Day 28 Based on the Injector's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the Facial Wrinkle Scale (FWS) — 108; 106 Number of Subjects
Summary
This study will evaluate the safety and efficacy of two different types of botulinum toxin type A for the treatment of glabellar frown lines.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With a Treatment Response at Day 28 Based on the Injector's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the Facial Wrinkle Scale (FWS) |
108; 106 | — |
| SECONDARY Number of Subjects With a Treatment Response at Day 84 Based on the Injector's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the FWS |
90; 80 | — |
| SECONDARY Number of Subjects With a Treatment Response at Day 98 Based on the Injector's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the FWS |
76; 70 | — |
| SECONDARY Number of Subjects With a Treatment Response at Day 112 Based on the Injector's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the FWS |
61; 56 | — |
| SECONDARY Number of Subjects With a Treatment Response at Day 28 Based on the Subject's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the FWS |
108; 102 | — |
| SECONDARY Number of Subjects With a Treatment Response at Day 84 Based on the Subject's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the FWS |
84; 78 | — |
| SECONDARY Number of Subjects With a Treatment Response at Day 98 Based on the Subject's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the FWS |
73; 68 | — |
| SECONDARY Number of Subjects With a Treatment Response at Day 112 Based on the Subject's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the FWS |
61; 54 | — |
Eligibility Criteria
Inclusion Criteria
- Moderate to severe glabellar frown lines
Exclusion Criteria
- Diagnosis of myasthenia gravis or Eaton Lambert syndrome
- Aesthetic treatment with botulinum toxin within 6 months or planned treatment with botulinum toxin for any reason during the study
- Prior filler treatments, surgeries, insertion procedures in/to the glabellar region
- Facial cosmetic procedures in the glabellar area within 6 months
- Bleeding disorders or use of anticoagulants within 10 days
- History of facial nerve palsy
Data sourced from ClinicalTrials.gov (NCT01271452). 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.