Comparison of Dysport Reconstitution at 1.5 mL and 2.5 mL for the Treatment of Moderate to Severe Glabellar Lines

Study Overview
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Brief Summary
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This study is designed to evaluate the safety, efficacy, and subject and investigator satisfaction of 2 different injection volumes of Dysport in the glabellar lines. To determine the proportion of composite responders (based on blinded evaluator and subject assessments) who achieve at least a 1-point reduction from baseline in glabellar line severity score (GLSS) at maximum frown line on Day 30. To assess the GLSS, at maximum frown and at rest, by live assessment at all visits. To evaluate the onset of effect on appearance of glabellar lines starting at the Day 2 visit (subject and blinded evaluator). To assess the subject's satisfaction with the treatment. To evaluate investigator satisfaction of treatment outcome. To evaluate subject psychological well-being. To evaluate subject age appraisal. To evaluate all adverse events during the course of the study.

Detailed Description
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Five month, randomized, subject- and evaluator-blinded, multi-center, mult-visit study. Subjects treated with Dysport following the US on-label guidelines.

Official Title
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A Prospective, Randomized, Multi-Center, Subject- and Evaluator-Blinded, Parallel Comparison of Dysport®, When Reconstituted at 1.5 mL and 2.5 mL, for the Treatment of Moderate to Severe Glabellar Lines.

Conditions
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Glabellar Lines, Wrinkles

Intervention / Treatment
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* Device: Dysport reconstituted at 1.5 mL (0.05 mL/injection)
* Device: Dysport reconstituted at 2.5 mL (0.08 mL/injection)


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Botulinum toxin naïve subject (facial area) Moderate to severe (GLSS = 2 or 3) glabellar lines at maximum frown and mild to severe (GLSS = 1, 2, or 3) glabellar lines at rest using the validated 4-point Photographic Scale, as assessed by the treating investigator and the blinded evaluator. Key Exclusion Criteria: Have known allergies or sensitivities to Dysport®, any of its excipients, or cow's milk protein Have rhytids of the glabellar region that cannot be smoothed out by manually spreading the skin apart Have a history or have signs and symptoms of eyelid or brow ptosis or signs of compensatory frontalis muscle activity, as judged by the investigator Have clinical or subclinical neuromuscular junctional disorders (eg, myasthenia gravis, Lambert Eaton syndrome, or amyotrophic lateral sclerosis) or a history of dysphagia or aspiration Are women who are pregnant or breast-feeding or who intend to get pregnant within the duration of the study Have an active inflammation or infection in the areas to be treated or had any prior surgery, tattoos, piercings, or scarring in the facial area that, in the opinion of the investigator, may interfere with the results Have had any previous insertion of any permanent or semi-permanent material, hyaluronic acid, or collagen fillers in the glabellar region Have any chronic or acute medical condition that, may pose a risk to the safety of the subject, or may interfere with the assessment of safety or efficacy in this study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1.5 mL Reconstitution<br>Subjects treated with Dysport reconstituted at 1.5 mL (0.05 mL/injection) following the US on-label guidelines, with each subject receiving a single treatment session (50 units [U]) at the Day 1 visit. | Device: Dysport reconstituted at 1.5 mL (0.05 mL/injection)<br>* Subjects treated for moderate to severe (GLSS = 2 or 3) glabellar lines at maximum frown.<br>|
| Experimental: 2.5 mL Reconstitution<br>Subjects treated with Dysport reconstituted at 2.5 mL (0.08 mL/injection) following the US on-label guidelines, with each subject receiving a single treatment session (50 units [U]) at the Day 1 visit. | Device: Dysport reconstituted at 2.5 mL (0.08 mL/injection)<br>* Subjects treated for moderate to severe (GLSS = 2 or 3) glabellar lines at maximum frown.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Composite Responders Who Achieve at Least a 1-point Reduction From Baseline in Glabellar Line Severity Score (GLSS) at Maximum Frown. | Proportion of composite responders who achieve at least a 1-point reduction from baseline in glabellar line severity score (GLSS) based on subject and blinded-evaluator assessment of glabellar line severity at maximum frown on Day 30. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Responders, at Maximum Frown (Subject) | Proportion of responders, at maximum frown, with GLSS at least 1-point reduction from baseline on days 2, 3, 4, 7, 14, 30, 90 and 120 based on assessments by subject using a static 4-point categorical (subject) scale. | 120 days | 
| Proportion of Responders, at Maximum Frown (Blinded Evaluator) | Proportion of responders, at maximum frown, with GLSS at least 1-point reduction from baseline on days 2, 3, 4, 7, 14, 30, 90 and 120 based on assessments by blinded evaluator using a validated 4-point photographic scale. | 120 days | 
| Proportion of Responders, at Maximum Frown (Treating Investigator) | Proportion of responders, at maximum frown, with GLSS at least 1-point reduction from baseline on days 2, 3, 4, 7, 14, 30, 90 and 120 based on assessments by treating investigator using a validated 4-point photographic scale. | 120 days | 
| Proportion of Combination Responders, at Maximum Frown (Blinded Evaluator and Subject) | Proportion of combination responders, at maximum frown, with GLSS at least 1-point reduction from baseline on days 2, 3, 4, 7, 14, 30, 90 and 120 based on assessments made by blinded evaluator and subject. | 120 days | 
| Proportion of Responders, at Rest (Subject) | Proportion of responders, at rest, with GLSS at least 1-point reduction from baseline on days 2, 3, 4, 7, 14, 30, 90 and 120 based on assessments made by subject using a static 4-point categorical (subject) scale. | 120 days | 
| Proportion of Responders, at Rest (Blinded Evaluator) | Proportion of responders, at rest, with GLSS at least 1-point reduction from baseline on days 2, 3, 4, 7, 14, 30, 90 and 120 based on assessments made by blinded evaluator using a validated 4-point photographic scale. | 120 days | 
| Proportion of Responders, at Rest (Treating Investigator) | Proportion of combination responders, at rest, with GLSS at least 1-point reduction from baseline on days 2, 3, 4, 7, 14, 30, 90 and 120 based on assessments made by treating investigator using a validated 4-point photographic scale. | 120 days | 
| Proportion of Combination Responders, at Rest (Blinded Evaluator and Subject) | Proportion of combination responders, at rest, with GLSS at least 1-point reduction from baseline on days 2, 3, 4, 7, 14, 30, 90 and 120 based on assessments made by blinded evaluator and subject. | 120 days | 
| Proportion of Subjects Who Achieved an Onset of Effect on the Appearance of the Subject's Glabellar Lines. | Combination endpoint from both subject and blinded evaluator assessments. Assessments made on days 2, 3, 4, and 7. | 7 days | 
| Subject Satisfaction With the Treatment of Glabellar Lines - I am Satisfied With How I Look. | Proportion of subjects who responded 'agree' or 'strongly agree' regarding change from baseline in subject satisfaction questionnaire on day 120. | 120 days | 
| Investigator Satisfaction With Treatment Outcome - Satisfied With the Study Product Results | Proportion of treating investigators who responded 'agree' or 'strongly agree' to the individual satisfaction questions on Day 30. | 30 days | 
| Subject Psychological Well-being - Mean Change at Day 120 Compared to Baseline | Mean change from baseline on day 120 using the Psychological Well-Being (FACE-Q).Total score for entire questionnaire is transformed to a Rasch score, scale of 0-100. Increase in score = increased well-being. | Baseline and Day 120 | 
| Subject Age Appraisal Using the FACE-Q-Age Appraisal Visual Analog Scale (VAS) - Mean Change at Day 120 Compared to Baseline | Mean change from baseline on day 120 using the FACE-Q Age Appraisal VAS. 0 years represents current age subjects rated their appearance as older or younger than current age; + years represents older than current age; - years represents younger than current age. | Baseline and Day 120 | 
| Subject Appraisal of Lines Between the Eyebrows (FACE-Q) - Mean Change at Day 120 Compared to Baseline | Mean change from baseline on day 120 using the Subject Appraisal Lines Between the Eyebrows (FACE-Q).Total score for entire questionnaire is transformed to a Rasch score, scale of 0-100. Increase in score = less bothered by glabellar lines. | Baseline and Day 120 |