Phase 4 N=40 Randomized Triple-blind Treatment

Patient Satisfaction Study of BOTOX® Cosmetic in the Treatment of Moderate to Severe Frown Lines

Glabellar Frown Lines

Bottom Line

View on ClinicalTrials.gov: NCT01391312 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2012

Primary outcome: Primary: Percentage of Participants With Improvement in Subject Global Assessment of Change at Day 30 — 94.7; 0.00 Percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: botulinum toxin Type A (Biological); normal saline (placebo) (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Allergan
Primary completion: Oct 2011

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	—

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.

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

View full record on ClinicalTrials.gov →

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.