Glabellar Lines, Wrinkles
Conditions
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.
Interventions
DEVICEDysport reconstituted at 1.5 mL (0.05 mL/injection)
Subjects treated for moderate to severe (GLSS = 2 or 3) glabellar lines at maximum frown.
DEVICEDysport reconstituted at 2.5 mL (0.08 mL/injection)
Subjects treated for moderate to severe (GLSS = 2 or 3) glabellar lines at maximum frown.
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Composite Responders Who Achieve at Least a 1-point Reduction From Baseline in Glabellar Line Severity Score (GLSS) at Maximum Frown. | 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
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Responders, at Maximum Frown (Blinded Evaluator) | 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. |
| Proportion of Responders, at Maximum Frown (Treating Investigator) | 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. |
| Proportion of Combination Responders, at Maximum Frown (Blinded Evaluator and Subject) | 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. |
| Proportion of Responders, at Rest (Subject) | 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. |
| Proportion of Responders, at Rest (Blinded Evaluator) | 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. |
| Proportion of Responders, at Rest (Treating Investigator) | 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. |
| Proportion of Responders, at Maximum Frown (Subject) | 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. |
| Proportion of Subjects Who Achieved an Onset of Effect on the Appearance of the Subject's Glabellar Lines. | 7 days | Combination endpoint from both subject and blinded evaluator assessments. Assessments made on days 2, 3, 4, and 7. |
| Subject Satisfaction With the Treatment of Glabellar Lines - I am Satisfied With How I Look. | 120 days | Proportion of subjects who responded 'agree' or 'strongly agree' regarding change from baseline in subject satisfaction questionnaire on day 120. |
| Investigator Satisfaction With Treatment Outcome - Satisfied With the Study Product Results | 30 days | Proportion of treating investigators who responded 'agree' or 'strongly agree' to the individual satisfaction questions on Day 30. |
| Subject Psychological Well-being - Mean Change at Day 120 Compared to Baseline | 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. |
| Subject Age Appraisal Using the FACE-Q-Age Appraisal Visual Analog Scale (VAS) - Mean Change at Day 120 Compared to Baseline | 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. |
| Subject Appraisal of Lines Between the Eyebrows (FACE-Q) - Mean Change at Day 120 Compared to Baseline | 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. |
| Proportion of Combination Responders, at Rest (Blinded Evaluator and Subject) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 30 |
| 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.
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. | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | 1.5 mL Reconstitution | Total | 2.5 mL Reconstitution |
|---|---|---|---|
| Age, Continuous | 45.1 years STANDARD_DEVIATION 10.93 | 45.8 years STANDARD_DEVIATION 11.26 | 46.5 years STANDARD_DEVIATION 11.73 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 29 Participants | 58 Participants | 29 Participants |
| Region of Enrollment United States | 30 participants | 30 participants | 30 participants |
| Sex: Female, Male Female | 26 Participants | 52 Participants | 26 Participants |
| Sex: Female, Male Male | 4 Participants | 8 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 2 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
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.
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 1.5 mL Reconstitution | Proportion of Composite Responders Who Achieve at Least a 1-point Reduction From Baseline in Glabellar Line Severity Score (GLSS) at Maximum Frown. | 27 Participants |
| 2.5 mL Reconstitution | Proportion of Composite Responders Who Achieve at Least a 1-point Reduction From Baseline in Glabellar Line Severity Score (GLSS) at Maximum Frown. | 26 Participants |
Secondary
Investigator Satisfaction With Treatment Outcome - Satisfied With the Study Product Results
Proportion of treating investigators who responded 'agree' or 'strongly agree' to the individual satisfaction questions on Day 30.
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 1.5 mL Reconstitution | Investigator Satisfaction With Treatment Outcome - Satisfied With the Study Product Results | 29 Participants |
| 2.5 mL Reconstitution | Investigator Satisfaction With Treatment Outcome - Satisfied With the Study Product Results | 26 Participants |
Secondary
Proportion of Combination Responders, at Maximum Frown (Blinded Evaluator and Subject)
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.
Time frame: 120 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 1.5 mL Reconstitution | Proportion of Combination Responders, at Maximum Frown (Blinded Evaluator and Subject) | 13 Participants |
| 2.5 mL Reconstitution | Proportion of Combination Responders, at Maximum Frown (Blinded Evaluator and Subject) | 14 Participants |
Secondary
Proportion of Combination Responders, at Rest (Blinded Evaluator and Subject)
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.
Time frame: 120 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 1.5 mL Reconstitution | Proportion of Combination Responders, at Rest (Blinded Evaluator and Subject) | 9 Participants |
| 2.5 mL Reconstitution | Proportion of Combination Responders, at Rest (Blinded Evaluator and Subject) | 10 Participants |
Secondary
Proportion of Responders, at Maximum Frown (Blinded Evaluator)
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.
Time frame: 120 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 1.5 mL Reconstitution | Proportion of Responders, at Maximum Frown (Blinded Evaluator) | 21 Participants |
| 2.5 mL Reconstitution | Proportion of Responders, at Maximum Frown (Blinded Evaluator) | 20 Participants |
Secondary
Proportion of Responders, at Maximum Frown (Subject)
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.
Time frame: 120 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 1.5 mL Reconstitution | Proportion of Responders, at Maximum Frown (Subject) | 14 Participants |
| 2.5 mL Reconstitution | Proportion of Responders, at Maximum Frown (Subject) | 17 Participants |
Secondary
Proportion of Responders, at Maximum Frown (Treating Investigator)
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.
Time frame: 120 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 1.5 mL Reconstitution | Proportion of Responders, at Maximum Frown (Treating Investigator) | 19 Participants |
| 2.5 mL Reconstitution | Proportion of Responders, at Maximum Frown (Treating Investigator) | 16 Participants |
Secondary
Proportion of Responders, at Rest (Blinded Evaluator)
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.
Time frame: 120 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 1.5 mL Reconstitution | Proportion of Responders, at Rest (Blinded Evaluator) | 14 Participants |
| 2.5 mL Reconstitution | Proportion of Responders, at Rest (Blinded Evaluator) | 14 Participants |
Secondary
Proportion of Responders, at Rest (Subject)
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.
Time frame: 120 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 1.5 mL Reconstitution | Proportion of Responders, at Rest (Subject) | 20 Participants |
| 2.5 mL Reconstitution | Proportion of Responders, at Rest (Subject) | 18 Participants |
Secondary
Proportion of Responders, at Rest (Treating Investigator)
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.
Time frame: 120 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 1.5 mL Reconstitution | Proportion of Responders, at Rest (Treating Investigator) | 17 Participants |
| 2.5 mL Reconstitution | Proportion of Responders, at Rest (Treating Investigator) | 17 Participants |
Secondary
Proportion of Subjects Who Achieved an Onset of Effect on the Appearance of the Subject's Glabellar Lines.
Combination endpoint from both subject and blinded evaluator assessments. Assessments made on days 2, 3, 4, and 7.
Time frame: 7 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 1.5 mL Reconstitution | Proportion of Subjects Who Achieved an Onset of Effect on the Appearance of the Subject's Glabellar Lines. | 28 Participants |
| 2.5 mL Reconstitution | Proportion of Subjects Who Achieved an Onset of Effect on the Appearance of the Subject's Glabellar Lines. | 28 Participants |
Secondary
Subject Age Appraisal Using the FACE-Q-Age Appraisal Visual Analog Scale (VAS) - Mean Change at Day 120 Compared to Baseline
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.
Time frame: Baseline and Day 120
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1.5 mL Reconstitution | Subject Age Appraisal Using the FACE-Q-Age Appraisal Visual Analog Scale (VAS) - Mean Change at Day 120 Compared to Baseline | -3.0 years | Standard Deviation 7.59 |
| 2.5 mL Reconstitution | Subject Age Appraisal Using the FACE-Q-Age Appraisal Visual Analog Scale (VAS) - Mean Change at Day 120 Compared to Baseline | -4.6 years | Standard Deviation 5.94 |
Secondary
Subject Appraisal of Lines Between the Eyebrows (FACE-Q) - Mean Change at Day 120 Compared to Baseline
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.
Time frame: Baseline and Day 120
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1.5 mL Reconstitution | Subject Appraisal of Lines Between the Eyebrows (FACE-Q) - Mean Change at Day 120 Compared to Baseline | 33.9 score on a scale | Standard Deviation 33.14 |
| 2.5 mL Reconstitution | Subject Appraisal of Lines Between the Eyebrows (FACE-Q) - Mean Change at Day 120 Compared to Baseline | 30.4 score on a scale | Standard Deviation 24.7 |
Secondary
Subject Psychological Well-being - Mean Change at Day 120 Compared to Baseline
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.
Time frame: Baseline and Day 120
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1.5 mL Reconstitution | Subject Psychological Well-being - Mean Change at Day 120 Compared to Baseline | 28.6 score on a scale | Standard Deviation 32.93 |
| 2.5 mL Reconstitution | Subject Psychological Well-being - Mean Change at Day 120 Compared to Baseline | 20.3 score on a scale | Standard Deviation 31.02 |
Secondary
Subject Satisfaction With the Treatment of Glabellar Lines - I am Satisfied With How I Look.
Proportion of subjects who responded 'agree' or 'strongly agree' regarding change from baseline in subject satisfaction questionnaire on day 120.
Time frame: 120 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 1.5 mL Reconstitution | Subject Satisfaction With the Treatment of Glabellar Lines - I am Satisfied With How I Look. | 19 Participants |
| 2.5 mL Reconstitution | Subject Satisfaction With the Treatment of Glabellar Lines - I am Satisfied With How I Look. | 20 Participants |