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

Phase 4

Completed

Brief 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)

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
1	botulinum toxin Type A	botulinum toxin Type A 20U

Primary Outcome Measures

Name	Time	Method
The First Visit Onset of Efficacy as Measured by Subject Assessment	14 Days	The first visit onset of efficacy as measured by subject assessment. Onset is determined by a yes/no answer to the question "Since being injected, have you noticed any effect on the appearance of your frown lines (lines between the eyebrows)?" at days 2, 3, 4, 7, and 14.
The First Visit Onset of Efficacy as Measured by Physician Assessment	14 Days	The first visit onset of efficacy as measured by physician assessment. Onset is determined by a yes/no answer to the question "Since injecting the patient, have you noticed any effect on the appearance of the patient's frown lines (lines between the eyebrows)?" at days 2, 3, 4, 7, and 14.

Secondary Outcome Measures

Name	Time	Method
Average Subject Assessment Score in Improvement of Appearance of Frown Lines	14 Days	Average subject assessment score in improvement of appearance of frown lines (lines between the eyebrows) as measured by a 7-point scale (1=very much improved and 7=very much worse)on a daily basis. The average scores over the 1st diary week (1-7 days) and the 2nd diary week (8-14 days) are presented.
Percentage of Patients Reporting Self-Perception of Age (SPA)	Baseline, Day 14	Percentage of patients reporting their SPA. SPA is measured by a questionnaire. Patients were asked to compare their facial appearance to their current age. Response options were "Looking younger", "Looking current age", and "Looking older". Results for each response are presented for Baseline and Day 14.
Change From Baseline in Patient Satisfaction as Measured by Facial Line Outcome (FLO) Questionnaire Score	Baseline, Day 14	Change from baseline in patient satisfaction as measured by FLO questionnaire comprised of 11 items that assess subject's perceptions about specific aspects of their facial lines for the previous 7 days. Each question is scored on a 11-point scale (0=not at all, 5=somewhat, 10=very much) and the sums are converted to the total FLO score. The minimum total FLO score is 0 (worst) and the maximum total FLO score is 100 (best). The total FLO score was calculated at baseline and Day 14. A positive number change from baseline indicates an improvement.