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

Study Overview
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Brief Summary
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This was a pilot study to observe patient satisfaction with BOTOX® Cosmetic treatment in glabellar rhytides (frown lines) using a new treatment satisfaction measure.

Official Title
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A Pilot Study of BOTOX® Cosmetic in the Treatment of Moderate to Severe Glabellar Lines - Establishing Patient Satisfaction

Conditions
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Glabellar Frown Lines

Intervention / Treatment
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* Biological: botulinum toxin Type A
* Drug: normal saline (placebo)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: botulinum toxin Type A<br>Botulinum toxin Type A 20U (total dose) injected into the glabellar region on Day 0. | Biological: botulinum toxin Type A<br>* botulinum toxin Type A 20U (total dose) injected into the glabellar region on Day 0.<br>* Other names: BOTOX® Cosmetic, Vistabel®, Vistabax®;|
| Placebo Comparator: placebo (Normal Saline)<br>Normal Saline (placebo) injected into the glabellar region on Day 0. | Drug: normal saline (placebo)<br>* Normal saline (placebo) injected into the glabellar region on Day 0.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Improvement in Subject Global Assessment of Change at Day 30 | Subjects assessed the improvement of their glabellar lines (area between the eyebrows) by answering the question: Compared to before receiving the study treatment, How do you currently feel about the appearance of your glabellar lines? on a 7-point scale where 0=Very much improved, 1=Much improved, 2=Minimally improved, 3=No change, 4=Minimally worse, 5=Much worse, 6=Very much worse. Improvement was defined as responses: 0=Very much improved, 1=Much improved and 2=Minimally improved. | Day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Facial Wrinkle Scale Responders at Maximum Attempted Muscle Contraction at Day 30 | The Investigator rated the subject's severity of glabellar lines (between the eyebrows) at maximum attempted muscle contraction using the 4-point Facial Wrinkle scale where 0=None (Best), 1=Mild, 2=Moderate, 3=Severe (Worse) at day 30. Responders were defined as participants with a score of 0=None or 1=Mild. | Day 30 | 
| Percentage of Facial Wrinkle Scale Responders at Maximum Attempted Muscle Contraction at Day 60 | The Investigator rated the subject's severity of glabellar lines (between the eyebrows) at maximum attempted muscle contraction using the 4-point Facial Wrinkle scale where 0=None (Best), 1=Mild, 2=Moderate, 3=Severe (Worse) at day 60. Responders were defined as participants with a score of 0=None or 1=Mild. | Day 60 |