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

NCT02718118 | Completed Phase 4 Results

• 1 other identifier: GLI.04.SPR.US10348
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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. 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. 2.To assess the GLSS, at maximum frown and at rest, by live assessment at all visits.
3. 3.To evaluate the onset of effect on appearance of glabellar lines starting at the Day 2 visit (subject and blinded evaluator).
4. 4.To assess the subject's satisfaction with the treatment.
5. 5.To evaluate investigator satisfaction of treatment outcome.
6. 6.To evaluate subject psychological well-being.
7. 7.To evaluate subject age appraisal.
8. 8.To evaluate all adverse events during the course of the study.

Conditions

Glabellar Lines; Wrinkles

Outcome Measures

Primary Outcomes (1)

• Proportion of Composite Responders Who Achieve at Least a 1-point Reduction From Baseline in Glabellar Line Severity Score (GLSS) at Maximum Frown.

  Proportion of composite responders who achieve at least a 1-point reduction from baseline in glabellar line severity score (GLSS) based on subject and blinded-evaluator assessment of glabellar line severity at maximum frown on Day 30.

  30 days

Secondary Outcomes (14)

• Proportion of Responders, at Maximum Frown (Subject)

  120 days

• Proportion of Responders, at Maximum Frown (Blinded Evaluator)

  120 days

• Proportion of Responders, at Maximum Frown (Treating Investigator)

  120 days

• Proportion of Combination Responders, at Maximum Frown (Blinded Evaluator and Subject)

  120 days

• Proportion of Responders, at Rest (Subject)

  120 days

Study Arms (2)

1.5 mL Reconstitution

EXPERIMENTAL

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.

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

2.5 mL Reconstitution

EXPERIMENTAL

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.

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

Interventions

Dysport reconstituted at 1.5 mL (0.05 mL/injection) DEVICE

Subjects treated for moderate to severe (GLSS = 2 or 3) glabellar lines at maximum frown.

1.5 mL Reconstitution

Dysport reconstituted at 2.5 mL (0.08 mL/injection) DEVICE

Subjects treated for moderate to severe (GLSS = 2 or 3) glabellar lines at maximum frown.

2.5 mL Reconstitution

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (3)

AboutSkin Dermatology and DermSurgery

Greenwood Village, Colorado, United States

Location

Skin Research Institute

Coral Gables, Florida, United States

Location

Marina Peredo, MD, PC

Smithtown, New York, United States

Location

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Results Point of Contact

• Title: Jay Mashburn
• Organization: Galderma Laboratories

jay.mashburn@galderma.com

Study Officials

• Jay Mashburn, PhD

  Galderma Laboratories, LP

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2016
• First Posted: March 24, 2016
• Study Start: April 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: August 1, 2022
• Results First Posted: September 25, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)