Phase 4
Completed N=40
Patient Satisfaction Study of BOTOX® Cosmetic in the Treatment of Moderate to Severe Frown Lines
Glabellar Frown Lines
Source: ClinicalTrials.gov NCT01391312 ↗
Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Sep 2012
Primary outcomePrimary: Percentage of Participants With Improvement in Subject Global Assessment of Change at Day 30 — 94.7; 0.00 Percentage of participants
Summary
This was a pilot study to observe patient satisfaction with BOTOX® Cosmetic treatment in glabellar rhytides (frown lines) using a new treatment satisfaction measure.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Improvement in Subject Global Assessment of Change at Day 30 |
94.7; 0.00 | — |
| SECONDARY Percentage of Facial Wrinkle Scale Responders at Maximum Attempted Muscle Contraction at Day 30 |
100; 10 | — |
| SECONDARY Percentage of Facial Wrinkle Scale Responders at Maximum Attempted Muscle Contraction at Day 60 |
77.8; 5.3 | — |
Eligibility Criteria
Inclusion Criteria
- Moderate to severe glabellar wrinkles (frown lines)
Exclusion Criteria
- Previous treatment with botulinum toxin therapy of any serotype
- Facial non-ablative resurfacing laser or light treatment, microdermabrasion, or superficial peels within 3 months
- Any facial cosmetic procedure with medium depth to deep facial chemical peels (e.g., trichloroacetic acid and phenol), mid-facial or periorbital laser skin resurfacing or permanent make-up within 6 months
- Mid-facial or periorbital treatment with non-permanent soft tissue fillers
- Subjects planning a facial cosmetic procedure or visible scars
- Previous cosmetic surgery to the upper face(e.g., prior periorbital surgery, facial lift, brow lift, eyelid lift or eyebrow surgery)
- Diagnoses of Myasthenia Gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis
- History of facial nerve palsy
- A planned extended absence during the study
Data sourced from ClinicalTrials.gov (NCT01391312). 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.