Clinical trial NCT02718118: Comparison of Dysport Reconstitution at 1.5 mL and 2.5 mL for the Treatment of Moderate to Severe Glabellar Lines
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glabellar Lines
Wrinkles
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2016-03-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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: 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

Primary outcomes:
measure: Proportion of Composite Responders Who Achieve at Least a 1-point Reduction From Baseline in Glabellar Line Severity Score (GLSS) at Maximum Frown.
timeFrame: 30 days
Secondary outcomes:
measure: Proportion of Responders, at Maximum Frown (Subject)
timeFrame: 120 days
measure: Proportion of Responders, at Maximum Frown (Blinded Evaluator)
timeFrame: 120 days
measure: Proportion of Responders, at Maximum Frown (Treating Investigator)
timeFrame: 120 days
measure: Proportion of Combination Responders, at Maximum Frown (Blinded Evaluator and Subject)
timeFrame: 120 days
measure: Proportion of Responders, at Rest (Subject)
timeFrame: 120 days
measure: Proportion of Responders, at Rest (Blinded Evaluator)
timeFrame: 120 days
measure: Proportion of Responders, at Rest (Treating Investigator)
timeFrame: 120 days
measure: Proportion of Combination Responders, at Rest (Blinded Evaluator and Subject)
timeFrame: 120 days
measure: Proportion of Subjects Who Achieved an Onset of Effect on the Appearance of the Subject's Glabellar Lines.
timeFrame: 7 days
measure: Subject Satisfaction With the Treatment of Glabellar Lines - I am Satisfied With How I Look.
timeFrame: 120 days
measure: Investigator Satisfaction With Treatment Outcome - Satisfied With the Study Product Results
timeFrame: 30 days
measure: Subject Psychological Well-being - Mean Change at Day 120 Compared to Baseline
timeFrame: Baseline and Day 120
measure: Subject Age Appraisal Using the FACE-Q-Age Appraisal Visual Analog Scale (VAS) - Mean Change at Day 120 Compared to Baseline
timeFrame: Baseline and Day 120
measure: Subject Appraisal of Lines Between the Eyebrows (FACE-Q) - Mean Change at Day 120 Compared to Baseline
timeFrame: Baseline and Day 120
Other outcomes:
Locations:
city: Greenwood Village
country: United States
facility: AboutSkin Dermatology and DermSurgery
state: Colorado
city: Coral Gables
country: United States
facility: Skin Research Institute
state: Florida
city: Smithtown
country: United States
facility: Marina Peredo, MD, PC
state: New York
Study officials:
affiliation: Galderma Laboratories, LP
name: Jay Mashburn, PhD
role: STUDY_DIRECTOR
References: