Phase 4 N=45 Treatment

Patient Satisfaction With Treatment of BOTOX® Cosmetic for the Temporary Correction of Moderate to Severe Glabellar Lines

Skin Aging

Bottom Line

View on ClinicalTrials.gov: NCT00856414 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2011

Primary outcome: Primary: The First Visit Onset of Efficacy as Measured by Physician Assessment — 2.2 Number of Days

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: botulinum toxin Type A (Biological)
Age: Adult · 35+ yrs
Sex: Female
Sponsor: Allergan
Primary completion: Apr 2009

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	—

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)

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

View full record on ClinicalTrials.gov →

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.