Phase 4
Completed N=60
Comparison of Dysport Reconstitution at 1.5 mL and 2.5 mL for the Treatment of Moderate to Severe Glabellar Lines
Glabellar Lines · Wrinkles
Source: ClinicalTrials.gov NCT02718118 ↗
Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Sep 2018
Primary outcomePrimary: Proportion of Composite Responders Who Achieve at Least a 1-point Reduction From Baseline in Glabellar Line Severity Score (GLSS) at Maximum Frown. — 27; 26 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
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.
1. 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.
2. To assess the GLSS, at maximum frown and at rest, by live assessment at all visits.
3. To evaluate the onset of effect on appearance of glabellar lines starting at the Day 2 visit (subject and blinded evaluator).
4. To assess the subject's satisfaction with the treatment.
5. To evaluate investigator satisfaction of treatment outcome.
6. To evaluate subject psychological well-being.
7. To evaluate subject age appraisal.
8. To evaluate all adverse events during the course of the study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Composite Responders Who Achieve at Least a 1-point Reduction From Baseline in Glabellar Line Severity Score (GLSS) at Maximum Frown. |
27; 26 | — |
| SECONDARY Proportion of Responders, at Maximum Frown (Subject) |
14; 17 | — |
| SECONDARY Proportion of Responders, at Maximum Frown (Blinded Evaluator) |
21; 20 | — |
| SECONDARY Proportion of Responders, at Maximum Frown (Treating Investigator) |
19; 16 | — |
| SECONDARY Proportion of Combination Responders, at Maximum Frown (Blinded Evaluator and Subject) |
13; 14 | — |
| SECONDARY Proportion of Responders, at Rest (Subject) |
20; 18 | — |
| SECONDARY Proportion of Responders, at Rest (Blinded Evaluator) |
14; 14 | — |
| SECONDARY Proportion of Responders, at Rest (Treating Investigator) |
17; 17 | — |
| SECONDARY Proportion of Combination Responders, at Rest (Blinded Evaluator and Subject) |
9; 10 | — |
| SECONDARY Proportion of Subjects Who Achieved an Onset of Effect on the Appearance of the Subject's Glabellar Lines. |
28; 28 | — |
| SECONDARY Subject Satisfaction With the Treatment of Glabellar Lines - I am Satisfied With How I Look. |
19; 20 | — |
| SECONDARY Investigator Satisfaction With Treatment Outcome - Satisfied With the Study Product Results |
29; 26 | — |
| SECONDARY Subject Psychological Well-being - Mean Change at Day 120 Compared to Baseline |
28.6; 20.3 | — |
| SECONDARY Subject Age Appraisal Using the FACE-Q-Age Appraisal Visual Analog Scale (VAS) - Mean Change at Day 120 Compared to Baseline |
-3.0; -4.6 | — |
| SECONDARY Subject Appraisal of Lines Between the Eyebrows (FACE-Q) - Mean Change at Day 120 Compared to Baseline |
33.9; 30.4 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02718118). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.