Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Forehead and Frown Lines

Study Overview
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Brief Summary
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This study evaluated the safety and efficacy of botulinum toxin Type A compared to placebo for the treatment of forehead lines (facial rhytides) when also administered to frown lines (glabellar rhytides).

Official Title
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A Multi-Centre, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Single Treatment Cycle Study of BOTOX® Cosmetic (Botulinum Toxin Type A) Purified Neurotoxin Complex in Subjects With Forehead and Glabellar Rhytides

Conditions
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Facial Rhytides, Glabellar Frown Lines

Intervention / Treatment
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* Biological: botulinum toxin Type A
* Drug: Normal Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Moderate to severe forehead lines Exclusion Criteria: Current or previous botulinum toxin treatment of any serotype within one year Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis Prior facial cosmetic surgery (e.g. prior periorbital surgery, facial lift, brow lift, eyelid lift or eyebrow surgery) Facial laser or light treatment, microdermabrasion, or superficial peels within 3 months Oral retinoid therapy within one year

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

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 (40 Units)<br>Botulinum toxin Type A 40 Units (total dose) injected into bilateral forehead and frown line areas on Day 1. | Biological: botulinum toxin Type A<br>* Botulinum toxin Type A (total dose 30 Units or 40 Units) injected into bilateral forehead and frown line areas on Day 1.<br>* Other names: BOTOX® Cosmetic;|
| Active Comparator: botulinum toxin Type A (30 Units)<br>Botulinum toxin Type A 30 Units (total dose) injected into bilateral forehead and frown line areas on Day 1. | Biological: botulinum toxin Type A<br>* Botulinum toxin Type A (total dose 30 Units or 40 Units) injected into bilateral forehead and frown line areas on Day 1.<br>* Other names: BOTOX® Cosmetic;|
| Placebo Comparator: placebo (Normal saline)<br>Placebo (Normal saline) injected into bilateral forehead and frown line areas on Day 1. | Drug: Normal Saline<br>* Normal Saline (placebo) injected into bilateral forehead and frown line areas on Day 1.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving a Score of None or Mild by Investigator-Assessed Facial Wrinkle Scale With Photonumeric Guide (FWS) in Forehead Lines at Maximum Eyebrow Elevation | The Investigator assessed the severity of the patient's forehead lines at maximum eyebrow elevation using the 4-point FWS: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a score of none or mild at Day 30. | Day 30 | 
| Percentage of Participants Achieving a Score of None or Mild by Subject-Assessed Facial Wrinkle Scale With Photonumeric Guide (FWS) in Forehead Lines at Maximum Eyebrow Elevation | The patient assessed the severity of their forehead lines at maximum eyebrow elevation using the 4-point FWS: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a score of none or mild at Day 30. | Day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving Satisfied or Very Satisfied by Subject Assessment of Satisfaction of Appearance of Forehead Lines | Participants rated their overall satisfaction with the appearance of the forehead line area using a 5-point scale: 1=very unsatisfied, 2=unsatisfied, 3=neutral, 4=satisfied or 5=very satisfied. The percentage of participants with a rating of satisfied or very satisfied at Day 30. | Day 30 | 
| Percentage of Participants With a ≥1 Grade Improvement From Baseline by Investigator-Assessed FWS in Forehead Lines at Rest | The Investigator assessed the severity of the patient's forehead lines at rest using the 4-point FWS: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a ≥1 grade improvement from baseline. | Baseline, Day 30 | 
| Percentage of Participants With a ≥1 Grade Improvement From Baseline by Subject-Assessed FWS in Forehead Lines at Rest | Participants assessed the severity of their forehead lines at rest using the 4-point FWS: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a ≥1 grade improvement from baseline. | Baseline, Day 30 |