ACKNOWLEDGEMENTS Study funded and editorial/poster support provided Galderma Laboratories, L.P.

TWO ON-LABEL INJECTION VOLUMES OF ABOBOTULINUMTOXINA (ABO) PRODUCE SIMILAR SAFETY AND EFFICACY RESULTS WHEN USED TO TREAT MODERATE TO SEVERE GLABELLAR LINES
Joely Kaufman, MD1; Joel Cohen, MD2; Marina Peredo, MD3; Brandie Jonas, MS4; Alessandra Nogueira, MD4; Jay H. Mashburn, PhD4

1Skin Associates of South Florida, Skin Research Institute, Coral Gables, FL; 2Director of AboutSkin Dermatology and DermSurgery, Greenwood Village and Lone Tree, CO, Associate Clinical Professor, Department of Dermatology, University of Colorado; Assistant Clinical Professor, Department of Dermatology, University of California Irvine; 3Marina I. Peredo, MD, Smithtown, NY; 4Galderma Laboratories, L.P., Fort Worth, TX

DYS.P-MA10348-06

INTRODUCTION
• Two injection volumes (0.05 mL and 0.08 mL) of Dysport® (abobotulinumtoxinA [ABO];

manufactured by Ipsen Biopharm Ltd, Wrexham, UK), reconstituted in either 1.5 mL or 2.5 mL
of sterile preservative-free 0.9% sodium chloride for injection USP, respectively, are approved
for the treatment of glabellar lines (GLs)1

• Even though both injection volumes are approved for reconstitution in the US label, many injectors
tend to believe that with the higher dilution volumes of neurotoxins, the greater risk of toxin
spread or other unwanted safety issues2

• This study aimed to show both injection volumes result in similar efficacy and safety profiles

REFERENCES
1. Dysport®. Prescribing Information. Fort Worth, TX: Galderma Laboratories, L.P., 2016.
2. Trindade De Almeida AR, Secco LC, Carruthers A. Handling botulinum toxins: an updated literature review. Dermatol Surg. 2011 Nov;37(11):1553-1565.
3. Honeck P, Weiss C, Sterry S, Gladys study group, et al. Reproducibility of a four-point clinical severity score for glabellar frown lines. Br J Dermatol. 2003;149:306-310.

SUMMARY
■ The study results demonstrated that treatment of moderate-to-severe GLs with either on-label injection volume

resulted in almost identical efficacy and safety profiles, rapid onset of effect, and provided a high degree of
clinician and subject satisfaction.

■ Responder rates for each treatment group were generally similar among all evaluations with the exception of
≥ 1-point composite responders at maximum frown at Day 2 (~ 24 hours post-treatment) where ABO 2.5 mL
treatment group (Group B) had a statistically significant larger number of responders compared to ABO 1.5 mL
treatment group (Group A; P = .0377).

■ High levels of subject satisfaction with appearance and natural looking outcome were maintained through
Day 120.

■ Both treatments provided a natural looking aesthetic outcome and were found to be safe and well tolerated. The
results of this study demonstrated that the higher injection volume produced similar effects for improvement of
GL severity and did not result in increased safety concerns compared to the lower volume.

SUBJECTS and METHODS

Subject Selection and Methods 

• This 120 day, multi-center, randomized, subject- and evaluator-blinded study enrolled subjects
with moderate Glabellar Line Severity Scores (GLSS=2) to severe (GLSS=3) who were naïve
to botulinum toxin treatment in the facial area

• Subjects were randomized (by age, gender, blinded evaluator GLSS) to receive either 0.05 mL/
injection (Group A) or 0.08 mL/injection (Group B). Subjects received 1 treatment which consisted
of 5 injections in the glabellar area. Each subject received a total of 50 U (10 U/injection site) of
ABO.

Primary Efficacy Endpoint
• The proportion of composite responders (defined as subjects who achieved at least a 1-point

reduction from baseline in the GLSS at maximum frown, based on the combined blinded evaluator
and subject assessments), at 30 days post-treatment using a validated 4-point photographic
scale3 for evaluators and a static 4-point categorical scale for subjects

Secondary Endpoints
• Subject and blinded evaluator assessment for Onset of Effect (OOE) at all time points
• The proportion of ≥1-point and ≥ 2-point composite responders at each study visit,

by evaluating the GLSS change from baseline (subject, blinded evaluator, and treating
investigator assessments)

• Treating investigator satisfaction at day 30 using 5-point Likert scale
• Subject satisfaction with appearance and naturalness of results using a subject questionnaire

and 5-point Likert scale (1=strongly disagree; 5=strongly agree) at 30 and 120 days post-
treatment

• Evaluation of treatment emergent adverse events (TEAEs) reported during the study

RESULTS

Demographics
• Sixty subjects (24-64 years old; mean age of 45.8 years) were enrolled. Subjects were primarily

female (86.7%) and Caucasian (96.7%) with moderate (25%) and severe (75%) GLLS scores at
maximum frown (baseline).

Glabellar Line Severity Scores

• 46.7% of subjects achieved at least a 1-point reduction in GLSS (based on combined subject and
blinded evaluator assessments) within 48 hours using either injection volume, this increased to
88.3% overall by 30 days post-treatment (Figure 1, representative photographs)

• At 48 hours post-treatment, 46.7% of subjects in both treatment groups were composite responders
with an increase to 70.0% (Group A) and 76.7% (Group B) by 72 hours post-treatment (Figure 2a).
The only statistically significant difference between treatments was noted at 24 hours post-treatment,
where 26.7% of subjects in Group B were considered composite responders compared to only 6.7%
in Group A (P=.0377; Figure 2a)

• At 30 day post-treatment, 90.0% of subjects in Group A and 86.7% of subjects in Group B were
considered composite responders (Figure 2a)

• For Group A composite responders at day 30, 70.0% achieved at least a 2-point reduction from
baseline in GLSS. For Group B composite responders at day 30, 63.3% achieved at least a 2-point
reduction from baseline in GLSS (Figure 2b).

Onset of Effect

• As early as 24 hours post-treatment, OOE was reported for 30.0% of subjects (based on combined
subject and blinded evaluator assessments) with no significant difference between treatment
groups. Within 48 hours, 73.3% of subjects had reported OOE.

• Within 24 hours post-treatment, 26.7% of subjects in Group A and 33.3% of subjects in Group B
experienced OOE (based on subject and blinded evaluator assessments); this increased to 76.7%
and 70.0% within 48 hours post-treatment, respectively (Figure 3).

Treating Investigator Satisfaction

• Investigators reported high satisfaction for both treatments
Subject Satisfaction

• At 30 days post-treatment, the majority of subjects (80.0% Group A, 83.3% Group B) agreed or
strongly agreed they were satisfied with how they looked compared to baseline (16.7% Group A,
16.7% Group B) and most subjects remained in agreement at day 120 (63.3% Group A, 66.7%
Group B; Figure 4a)

• At 30 days post-treatment, the majority of subjects (90.0% Group A, 93.3% Group B) agreed
or strongly agreed that treatment provided a natural looking appearance compared to baseline
(40.0% Group A, 36.7% Group B) and most subjects remained in agreement at day 120 (80.0%
Group A, 80.0% Group B; Figure 4b)

Safety

• A total of 13 treatment emergent adverse events (TEAEs) were reported in 6 subjects (3 subjects
from each treatment group); 9 TEAEs reported in 3 subjects were assessed as related to treatment
(2 subjects in Group A, 1 subject in Group B; Table 1)

• No SAEs were reported and both treatments were well-tolerated

26.7

33.3

76.7

70.0

90.0

83.3
93.3 96.7

0

20

40

60

80

100

24 hrs 48 hrs 72 hrs 7 days 9 days

Time, post-treatment

Pe
rce

nt
 o

f S
ub

je
cts

Group A (n=30)
Group B (n=30)

96.793.3

Figure 3. Proportion of Subjects Who Achieved Onset of Effect (OOE), Based on Combined 
Subject and Blinded Evaluator Assessments (n = 60) – mITT Population

1.5 mL = 0.05 mL/injection, n=30; 2.5 mL = 0.08 mL/injection, n=30; mITT = modified intent to treat

6.7

46.7

70.0

86.7
93.3 90.0

56.7

43.326.7

46.7

76.7
83.3

90.0 86.7

66.7

46.7

0

20

40

60

80

100

24 hrs 48 hrs

*

72 hrs 6 days 2 weeks 4 weeks 3 months 4 months

Group A (n = 30) Group B (n = 30)

Time, post-treatment

%
 o

f S
ub

je
cts

10

30

40

60

0

20

50

70

80

90

100
I am satisfied with how I look

Pe
rce

nt
 o

f S
ub

je
cts

, A
gr

ee
/S

tro
ng

ly 
Ag

re
e

Baseline Day 30 Day 120

66.7
63.3

83.3
80.0

16.7 16.7

Group A (n=30)
Group B (n=30)

10.0
3.3

46.7

46.7
63.3 63.3

3.3
16.7

0.0

16.7

6.7

63.3
70.0

13.3

26.7

0

20

40

60

80

100

24 hrs 48 hrs 72 hrs 6 days 2 weeks 4 weeks 3 months 4 months

Group A (n = 30) Group B (n = 30)

Time, post-treatment
10

30

40

60

0

20

50

70

80

90

100
My face looks natural

Pe
rce

nt
 o

f S
ub

je
cts

, A
gr

ee
/S

tro
ng

ly 
Ag

re
e

Baseline Day 30 Day 120

80.080.0

93.3
90.0

40.0
36.7

Group A (n=30)
Group B (n=30)

Figure 4. Subject Satisfaction at Days 30 and 120, Relative to Baseline (n=60) – mITT 
Population

2a) Proportion of composite responders with at least a 1-point reduction from baseline in GLSS, maximum frown (n = 60);  
mITT Population

4a) Subject Satisfaction, Satisfaction with Overall Look

2b) Proportion of composite responders with at least a 2-point reduction from baseline in GLSS, maximum frown (n = 60);  
mITT Population

Group A (1.5 mL) – 0.05 mL/injection; Group B (2.5 mL) – 0.08 mL/injection; *P=.0377, Group A compared to Group B; Composite 
Responders = based on combined subject and blinded evaluator assessments; mITT = modified intent to treat

Group A (1.5 mL) – 0.05 mL/injection; Group B (2.5 mL) – 0.08 mL/injection; Composite Responders = based on combined subject and 
blinded evaluator assessments; mITT = modified intent to treat

Group A (1.5 mL) – 0.05 mL/injection; Group B (2.5 mL) – 0.08 mL/injection; mITT = modified intent to treat

Group A (1.5 mL) – 0.05 mL/injection; Group B (2.5 mL) – 0.08 mL/injection; mITT = modified intent to treat

Table 1. Summary of Treatment-Emergent Adverse Events (TEAEs)

Group A
(n=30)

Group B
(n=30)

Number of Subjects with ≥ 1 TEAE, n (%) 3 (10) 3 (10)
Number of Subjects with Related TEAE, n (%)* 2 (6.7) 1 (3.3)

Vision blurred 1 (3.3) 0 (0)
Injection site pain 1 (3.3) 0 (0)

Injection site swelling 1 (3.3) 0 (0)
Headache 2 (6.7) 0 (0)
Migraine 1 (3.3) 0 (0)
Dry skin 1 (3.3) 0 (0)

Skin hyperpgimentation 0 (0) 1 (3.3)
Number of Subjects with Not Related TEAE, n (%) 1 (3.3) 2 (6.7)

Seasonal allergies 1 (3.3) 0 (0)
Bronchitis 0 (0) 1 (3.3)

Nasopharyngitis 0 (0) 1 (3.3)
Dermatitis contact 1 (3.3) 0 (0)

Safety Population = 60 subjects. Group A (1.5 mL) – 0.05 mL/injection; Group B (2.5 mL) – 0.08 mL/
injection. Counts reflect the number of subjects experiencing TEAEs, not the number of TEAEs.

*One subject had multiple events: headache, migraine, injection site pain, and injection site swelling

43b) Subject Satisfaction, Natural Looking Appearance

Baseline Max Frown
GLSS = 3

Day 30 Max Frown
GLSS = 0

Figure 1. Representative Photographs - Subject 138-003

Figure 2. Proportion of Composite Responders

Treated with 1.5 mL Reconstitution


	FC17PosterGaldermaKaufmanTwoOnLabelVolumes.pdf