Overview

This trial is active, not recruiting.

Conditions glabellar lines, wrinkles
Treatments dysport reconstituted at 1.5 ml (0.05 ml/injection), dysport reconstituted at 2.5 ml (0.08 ml/injection)
Phase phase 4
Sponsor Galderma Laboratories, L.P.
Start date April 2016
End date October 2016
Trial size 60 participants
Trial identifier NCT02718118, GLI.04.SPR.US10348

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Subjects will be 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.
dysport reconstituted at 1.5 ml (0.05 ml/injection)
Subjects will be treated for moderate to severe (GLSS = 2 or 3) glabellar lines at maximum frown.
(Experimental)
Subjects will be 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.
dysport reconstituted at 2.5 ml (0.08 ml/injection)
Subjects will be treated for moderate to severe (GLSS = 2 or 3) glabellar lines at maximum frown.

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.
time frame: 30 days

Secondary Outcomes

Measure
Proportion of responders, at maximum frown (Subject)
time frame: 120 days
Proportion of responders, at maximum frown (Blinded Evaluator)
time frame: 120 days
Proportion of responders, at maximum frown (Treating Investigator)
time frame: 120 days
Proportion of combination responders, at maximum frown (Blinded Evaluator and Subject)
time frame: 120 days
Proportion of responders, at rest (Subject)
time frame: 120 days
Proportion of responders, at rest (Blinded Evaluator)
time frame: 120 days
Proportion of responders, at rest (Treating Investigator)
time frame: 120 days
Proportion of combination responders, at rest (Blinded Evaluator and Subject)
time frame: 120 days
Proportion of subjects who achieve an onset of effect on the appearance of the subject's glabellar lines.
time frame: 7 days
Subject satisfaction with the treatment of glabellar lines.
time frame: 120 days
Investigator satisfaction with treatment outcome.
time frame: 30 days
Subject psychological well-being
time frame: 120 days
Subject age appraisal using the FACE-Q-Age Appraisal Visual Analog Scale (VAS).
time frame: 120 days
Incidence rate of subjects with any adverse events.
time frame: 120 days

Eligibility Criteria

Male or female participants from 18 years up to 64 years old.

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

Additional Information

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.
Description Five month, randomized, subject- and evaluator-blinded, multi-center, mult-visit study. Subjects treated with Dysport following the US on-label guidelines.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Galderma Laboratories, L.P..