Phase 4
Completed N=45
Patient Satisfaction With Treatment of BOTOX® Cosmetic for the Temporary Correction of Moderate to Severe Glabellar Lines
Source: ClinicalTrials.gov NCT00856414 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Dec 2011
Primary outcomePrimary: The First Visit Onset of Efficacy as Measured by Physician Assessment — 2.2 Number of Days
Summary
This study evaluates the patient satisfaction and onset of effect following treatment with botulinum toxin Type A in the treatment of glabellar rhytids (frown lines)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The First Visit Onset of Efficacy as Measured by Physician Assessment |
2.2 | — |
| PRIMARY The First Visit Onset of Efficacy as Measured by Subject Assessment |
1.84 | — |
| SECONDARY Average Subject Assessment Score in Improvement of Appearance of Frown Lines |
1.73; 2.64 | — |
| SECONDARY Change From Baseline in Patient Satisfaction as Measured by Facial Line Outcome (FLO) Questionnaire Score |
32.97; 38.55 | — |
| SECONDARY Percentage of Patients Reporting Self-Perception of Age (SPA) |
22.2; 40.0; 37.8; 42.2; 44.4; 13.3 | — |
Eligibility Criteria
Inclusion Criteria
- Female subjects of any race, 35-55 years of age
- Moderate to severe glabellar wrinkles (lines between the eyebrows)
Exclusion Criteria
- Previous botulinum toxin therapy
- Subjects who are pregnant, breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control
- Subjects planning a facial cosmetic procedure or visible scars
- Previous cosmetic surgery to the upper face
- Medical condition that may increase their risk of exposure to botulinum toxin including diagnosed Myasthenia Gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis, or any other disease that might interfere with neuromuscular function
- History of facial nerve palsy
- Allergy or sensitivity to any component of the study medication
Data sourced from ClinicalTrials.gov (NCT00856414). 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.