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

NCT ID: NCT02718118

Last Updated: 2022-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2016-10-31

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.

Conditions

Glabellar Lines; Wrinkles

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1.5 mL Reconstitution

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.

Group Type: EXPERIMENTAL

Dysport reconstituted at 1.5 mL (0.05 mL/injection)

Intervention Type: DEVICE

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

2.5 mL Reconstitution

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.

Group Type: EXPERIMENTAL

Dysport reconstituted at 2.5 mL (0.08 mL/injection)

Intervention Type: DEVICE

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

Interventions

Dysport reconstituted at 1.5 mL (0.05 mL/injection)

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

Intervention Type: DEVICE

Dysport reconstituted at 2.5 mL (0.08 mL/injection)

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

Intervention Type: DEVICE

Eligibility Criteria

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.

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Galderma R&D

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jay Mashburn, PhD

Role: STUDY_DIRECTOR

Galderma Laboratories, LP

Locations

AboutSkin Dermatology and DermSurgery

Greenwood Village, Colorado, United States

Skin Research Institute

Coral Gables, Florida, United States

Marina Peredo, MD, PC

Smithtown, New York, United States

Countries

United States

Other Identifiers

GLI.04.SPR.US10348

Identifier Type: -

Identifier Source: org_study_id