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

Galderma

Status and phase: Completed; Phase 4

Conditions: Wrinkles; Glabellar Lines

Treatments: Device: Dysport reconstituted at 2.5 mL (0.08 mL/injection); Device: Dysport reconstituted at 1.5 mL (0.05 mL/injection)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02718118

GLI.04.SPR.US10348

Details and patient eligibility

About

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.

Full description

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

Enrollment: 60 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

1.5 mL Reconstitution

Experimental group

Description:

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.

Treatment:

Device: Dysport reconstituted at 1.5 mL (0.05 mL/injection)

2.5 mL Reconstitution

Experimental group

Description:

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.

Treatment:

Device: Dysport reconstituted at 2.5 mL (0.08 mL/injection)