Status:
COMPLETED
Comparison of Dysport Reconstitution at 1.5 mL and 2.5 mL for the Treatment of Moderate to Severe Glabellar Lines
Lead Sponsor:
Galderma R&D
Conditions:
Glabellar Lines
Wrinkles
Eligibility:
All Genders
18-64 years
Phase:
PHASE4
Brief 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 o...
Detailed Description
Five month, randomized, subject- and evaluator-blinded, multi-center, mult-visit study. Subjects treated with Dysport following the US on-label guidelines.
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
April 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT02718118
Start Date
April 1 2016
End Date
October 1 2016
Last Update
August 1 2022
Active Locations (3)
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1
AboutSkin Dermatology and DermSurgery
Greenwood Village, Colorado, United States
2
Skin Research Institute
Coral Gables, Florida, United States
3
Marina Peredo, MD, PC
Smithtown, New York, United States