Trial Outcomes & Findings for Comparison of Dysport Reconstitution at 1.5 mL and 2.5 mL for the Treatment of Moderate to Severe Glabellar Lines (NCT NCT02718118)

NCT ID: NCT02718118

Last Updated: 2022-08-01

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 60 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2022-08-01

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	30	30
Overall Study COMPLETED	28	29
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	1.5 mL Reconstitution n=30 Participants 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.	2.5 mL Reconstitution n=30 Participants 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.	Total n=60 Participants Total of all reporting groups
Age, Continuous	45.1 years STANDARD_DEVIATION 10.93 • n=5 Participants	46.5 years STANDARD_DEVIATION 11.73 • n=7 Participants	45.8 years STANDARD_DEVIATION 11.26 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	26 Participants n=7 Participants	52 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	29 Participants n=5 Participants	29 Participants n=7 Participants	58 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants	30 participants n=7 Participants	30 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	1.5 mL Reconstitution n=30 Participants 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.	2.5 mL Reconstitution n=30 Participants 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.
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	26 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	1.5 mL Reconstitution n=30 Participants 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.	2.5 mL Reconstitution n=30 Participants 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.
Proportion of Responders, at Maximum Frown (Subject)	14 Participants	17 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	1.5 mL Reconstitution n=30 Participants 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.	2.5 mL Reconstitution n=30 Participants 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.
Proportion of Responders, at Maximum Frown (Blinded Evaluator)	21 Participants	20 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	1.5 mL Reconstitution n=30 Participants 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.	2.5 mL Reconstitution n=30 Participants 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.
Proportion of Responders, at Maximum Frown (Treating Investigator)	19 Participants	16 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	1.5 mL Reconstitution n=30 Participants 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.	2.5 mL Reconstitution n=30 Participants 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.
Proportion of Combination Responders, at Maximum Frown (Blinded Evaluator and Subject)	13 Participants	14 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	1.5 mL Reconstitution n=30 Participants 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.	2.5 mL Reconstitution n=30 Participants 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.
Proportion of Responders, at Rest (Subject)	20 Participants	18 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	1.5 mL Reconstitution n=30 Participants 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.	2.5 mL Reconstitution n=30 Participants 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.
Proportion of Responders, at Rest (Blinded Evaluator)	14 Participants	14 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	1.5 mL Reconstitution n=30 Participants 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.	2.5 mL Reconstitution n=30 Participants 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.
Proportion of Responders, at Rest (Treating Investigator)	17 Participants	17 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	1.5 mL Reconstitution n=30 Participants 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.	2.5 mL Reconstitution n=30 Participants 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.
Proportion of Combination Responders, at Rest (Blinded Evaluator and Subject)	9 Participants	10 Participants

SECONDARY outcome

Timeframe: 7 days

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

Outcome measures

Measure	1.5 mL Reconstitution n=30 Participants 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.	2.5 mL Reconstitution n=30 Participants 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.
Proportion of Subjects Who Achieved an Onset of Effect on the Appearance of the Subject's Glabellar Lines.	28 Participants	28 Participants

SECONDARY outcome

Timeframe: 120 days

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

Outcome measures

Measure	1.5 mL Reconstitution n=30 Participants 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.	2.5 mL Reconstitution n=30 Participants 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.
Subject Satisfaction With the Treatment of Glabellar Lines - I am Satisfied With How I Look.	19 Participants	20 Participants

SECONDARY outcome

Timeframe: 30 days

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

Outcome measures

Measure	1.5 mL Reconstitution n=30 Participants 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.	2.5 mL Reconstitution n=30 Participants 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.
Investigator Satisfaction With Treatment Outcome - Satisfied With the Study Product Results	29 Participants	26 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	1.5 mL Reconstitution n=30 Participants 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.	2.5 mL Reconstitution n=30 Participants 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.
Subject Psychological Well-being - Mean Change at Day 120 Compared to Baseline	28.6 score on a scale Standard Deviation 32.93	20.3 score on a scale Standard Deviation 31.02

SECONDARY outcome

Timeframe: 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".

Outcome measures

Measure	1.5 mL Reconstitution n=30 Participants 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.	2.5 mL Reconstitution n=30 Participants 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.
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	-4.6 years Standard Deviation 5.94

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	1.5 mL Reconstitution n=30 Participants 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.	2.5 mL Reconstitution n=30 Participants 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.
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	30.4 score on a scale Standard Deviation 24.70

Adverse Events

1.5 mL Reconstitution

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

2.5 mL Reconstitution

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	1.5 mL Reconstitution n=30 participants at risk 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.	2.5 mL Reconstitution n=30 participants at risk 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.
Nervous system disorders Headache	6.7% 2/30 • Number of events 2 • 120 days	0.00% 0/30 • 120 days

Additional Information

Jay Mashburn

Galderma Laboratories

Email: jay.mashburn@galderma.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place