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

Study Overview
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Brief Summary
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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)

Conditions
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Skin Aging

Intervention / Treatment
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* Biological: botulinum toxin Type A


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>botulinum toxin Type A 20U | Biological: botulinum toxin Type A<br>* 20U, up to two injections administered intramuscularly into the glabella (2 in each side of the corrugators and 1 in the procerus)<br>* Other names: BOTOX®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The First Visit Onset of Efficacy as Measured by Physician Assessment | 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. | 14 Days | 
| The First Visit Onset of Efficacy as Measured by Subject Assessment | 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. | 14 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Subject Assessment Score in Improvement of Appearance of Frown Lines | 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. | 14 Days | 
| Change From Baseline in Patient Satisfaction as Measured by Facial Line Outcome (FLO) Questionnaire Score | 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. | Baseline, Day 14 | 
| Percentage of Patients Reporting Self-Perception of Age (SPA) | 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. | Baseline, Day 14 |