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Completed

NCT Number: NCT02718118

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

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.

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Key information

Conditions

Glabellar Lines Wrinkles

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

AboutSkin Dermatology and DermSurgery, Greenwood Village, Colorado, United States

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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.

Key Exclusion Criteria:

  • 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

Treatment and study plan

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.

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.

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.

    Time frame: 30 days

    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.

Secondary outcomes

  1. Proportion of Responders, at Maximum Frown (Subject)

    Time frame: 120 days

    Proportion of responders, at maximum frown, with GLSS at least 1-point reduction from baseline on days 2, 3, 4, 7, 14, 30, 90 and 120 based on assessments by subject using a static 4-point categorical (subject) scale.

  2. Proportion of Responders, at Maximum Frown (Blinded Evaluator)

    Time frame: 120 days

    Proportion of responders, at maximum frown, with GLSS at least 1-point reduction from baseline on days 2, 3, 4, 7, 14, 30, 90 and 120 based on assessments by blinded evaluator using a validated 4-point photographic scale.

  3. Proportion of Responders, at Maximum Frown (Treating Investigator)

    Time frame: 120 days

    Proportion of responders, at maximum frown, with GLSS at least 1-point reduction from baseline on days 2, 3, 4, 7, 14, 30, 90 and 120 based on assessments by treating investigator using a validated 4-point photographic scale.

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

    Time frame: 120 days

    Proportion of combination responders, at maximum frown, with GLSS at least 1-point reduction from baseline on days 2, 3, 4, 7, 14, 30, 90 and 120 based on assessments made by blinded evaluator and subject.

  5. Proportion of Responders, at Rest (Subject)

    Time frame: 120 days

    Proportion of responders, at rest, with GLSS at least 1-point reduction from baseline on days 2, 3, 4, 7, 14, 30, 90 and 120 based on assessments made by subject using a static 4-point categorical (subject) scale.

  6. Proportion of Responders, at Rest (Blinded Evaluator)

    Time frame: 120 days

    Proportion of responders, at rest, with GLSS at least 1-point reduction from baseline on days 2, 3, 4, 7, 14, 30, 90 and 120 based on assessments made by blinded evaluator using a validated 4-point photographic scale.

  7. Proportion of Responders, at Rest (Treating Investigator)

    Time frame: 120 days

    Proportion of combination responders, at rest, with GLSS at least 1-point reduction from baseline on days 2, 3, 4, 7, 14, 30, 90 and 120 based on assessments made by treating investigator using a validated 4-point photographic scale.

  8. Proportion of Combination Responders, at Rest (Blinded Evaluator and Subject)

    Time frame: 120 days

    Proportion of combination responders, at rest, with GLSS at least 1-point reduction from baseline on days 2, 3, 4, 7, 14, 30, 90 and 120 based on assessments made by blinded evaluator and subject.

  9. Proportion of Subjects Who Achieved an Onset of Effect on the Appearance of the Subject's Glabellar Lines.

    Time frame: 7 days

    Combination endpoint from both subject and blinded evaluator assessments. Assessments made on days 2, 3, 4, and 7.

  10. Subject Satisfaction With the Treatment of Glabellar Lines - I am Satisfied With How I Look.

    Time frame: 120 days

    Proportion of subjects who responded 'agree' or 'strongly agree' regarding change from baseline in subject satisfaction questionnaire on day 120.

  11. Investigator Satisfaction With Treatment Outcome - Satisfied With the Study Product Results

    Time frame: 30 days

    Proportion of treating investigators who responded 'agree' or 'strongly agree' to the individual satisfaction questions on Day 30.

  12. Subject Psychological Well-being - Mean Change at Day 120 Compared to Baseline

    Time frame: Baseline and Day 120

    Mean change from baseline on day 120 using the Psychological Well-Being (FACE-Q).Total score for entire questionnaire is transformed to a Rasch score, scale of 0-100.

    Increase in score = increased well-being.

  13. Subject Age Appraisal Using the FACE-Q-Age Appraisal Visual Analog Scale (VAS) - Mean Change at Day 120 Compared to Baseline

    Time frame: Baseline and Day 120

    Mean change from baseline on day 120 using the FACE-Q Age Appraisal VAS. "0" years represents "current age subjects rated their appearance as older or younger than current age"; "+" years represents "older than current age"; "-" years represents "younger than current age".

  14. Subject Appraisal of Lines Between the Eyebrows (FACE-Q) - Mean Change at Day 120 Compared to Baseline

    Time frame: Baseline and Day 120

    Mean change from baseline on day 120 using the Subject Appraisal Lines Between the Eyebrows (FACE-Q).Total score for entire questionnaire is transformed to a Rasch score, scale of 0-100. Increase in score = less bothered by glabellar lines.

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study 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.

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Mar 24, 2016
Registry last updated
Aug 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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