Comparison of Dysport Reconstitution at 1.5 mL and 2.5 mL for the Treatment of Moderate to Severe Glabellar Lines
| Status: | Completed |
|---|---|
| Conditions: | Cosmetic |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 18 - 64 |
| Updated: | 10/25/2018 |
| Start Date: | April 2016 |
| End Date: | October 2016 |
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.
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.
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.
Five month, randomized, subject- and evaluator-blinded, multi-center, mult-visit study.
Subjects treated with Dysport following the US on-label guidelines.
Subjects treated with Dysport following the US on-label guidelines.
Key Inclusion Criteria:
1. Botulinum toxin naïve subject (facial area)
2. 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:
1. Have known allergies or sensitivities to Dysport®, any of its excipients, or cow's
milk protein
2. Have rhytids of the glabellar region that cannot be smoothed out by manually spreading
the skin apart
3. 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
4. Have clinical or subclinical neuromuscular junctional disorders (eg, myasthenia
gravis, Lambert Eaton syndrome, or amyotrophic lateral sclerosis) or a history of
dysphagia or aspiration
5. Are women who are pregnant or breast-feeding or who intend to get pregnant within the
duration of the study
6. 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
7. Have had any previous insertion of any permanent or semi-permanent material,
hyaluronic acid, or collagen fillers in the glabellar region
8. 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
We found this trial at
3
sites
Smithtown, New York
Principal Investigator: Marina Peredo, MD
Phone: 631-863-3223
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Coral Gables, Florida 33146
Principal Investigator: Joely Kaufman-Janette, MD
Phone: 305-444-5770
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Greenwood Village, Colorado
Principal Investigator: Joel Cohen, MD
Phone: 303-756-7546
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