Trial Outcomes & Findings for Safety and Efficacy of Azzalure/Dysport, Restylane/Emervel Filler and Restylane Skinbooster Treatment (NCT NCT02297516)
NCT ID: NCT02297516
Last Updated: 2022-10-14
Results Overview
Percentage of subjects showing superior global facial aesthetic appearance at month 7 compared to month 1. Assessment of global facial aesthetic appearance was based on blinded evaluations of subject's youthful appearance (e.g. lack of facial volume loss, lack of static wrinkles and fine lines, good skin quality, and satisfactory result after aesthetic treatment). The blinded evaluators retrospectively reviewed photographs from visit for each subject and answered the following question: "At which set of photographs does the subject show superior global facial aesthetic appearance?".
COMPLETED
PHASE4
65 participants
7 months
2022-10-14
Participant Flow
Participant milestones
| Measure |
Azzalure/Dysport as Single Treatment
Azzalure/Dysport as single treatment at initial treatment
Azzalure or Dysport: Upper facial lines
Restylane or Emervel filler: Facial tissue augmentation
Restylane Skinbooster: Facial skin rejuvenation
|
Filler as Single Treatment
Filler as single treatment at initial treatment
Azzalure or Dysport: Upper facial lines
Restylane or Emervel filler: Facial tissue augmentation
Restylane Skinbooster: Facial skin rejuvenation
|
|---|---|---|
|
Single Treatment Phase (6 Months)
STARTED
|
32
|
33
|
|
Single Treatment Phase (6 Months)
COMPLETED
|
31
|
31
|
|
Single Treatment Phase (6 Months)
NOT COMPLETED
|
1
|
2
|
|
Combination Treatment Phase (up to 18 m)
STARTED
|
31
|
31
|
|
Combination Treatment Phase (up to 18 m)
COMPLETED
|
31
|
30
|
|
Combination Treatment Phase (up to 18 m)
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Azzalure/Dysport as Single Treatment
Azzalure/Dysport as single treatment at initial treatment
Azzalure or Dysport: Upper facial lines
Restylane or Emervel filler: Facial tissue augmentation
Restylane Skinbooster: Facial skin rejuvenation
|
Filler as Single Treatment
Filler as single treatment at initial treatment
Azzalure or Dysport: Upper facial lines
Restylane or Emervel filler: Facial tissue augmentation
Restylane Skinbooster: Facial skin rejuvenation
|
|---|---|---|
|
Single Treatment Phase (6 Months)
Medical reason
|
1
|
0
|
|
Single Treatment Phase (6 Months)
Protocol Violation
|
0
|
2
|
|
Combination Treatment Phase (up to 18 m)
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Safety and Efficacy of Azzalure/Dysport, Restylane/Emervel Filler and Restylane Skinbooster Treatment
Baseline characteristics by cohort
| Measure |
Azzalure/Dysport as Single Treatment
n=32 Participants
Azzalure/Dysport as single treatment at initial treatment
Azzalure or Dysport: Upper facial lines
Restylane or Emervel filler: Facial tissue augmentation
Restylane Skinbooster: Facial skin rejuvenation
|
Filler as Single Treatment
n=33 Participants
Filler as single treatment at initial treatment
Azzalure or Dysport: Upper facial lines
Restylane or Emervel filler: Facial tissue augmentation
Restylane Skinbooster: Facial skin rejuvenation
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.9 years
n=5 Participants
|
44.8 years
n=7 Participants
|
44.4 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
32 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
8 participants
n=5 Participants
|
9 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Region of Enrollment
France
|
16 participants
n=5 Participants
|
16 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Smoking
|
13 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 7 monthsPopulation: One subject in Group A was excluded from the analysis due to the wrong photographs being used in the evaluation.
Percentage of subjects showing superior global facial aesthetic appearance at month 7 compared to month 1. Assessment of global facial aesthetic appearance was based on blinded evaluations of subject's youthful appearance (e.g. lack of facial volume loss, lack of static wrinkles and fine lines, good skin quality, and satisfactory result after aesthetic treatment). The blinded evaluators retrospectively reviewed photographs from visit for each subject and answered the following question: "At which set of photographs does the subject show superior global facial aesthetic appearance?".
Outcome measures
| Measure |
Azzalure/Dysport as Single Treatment
n=30 Participants
Azzalure/Dysport as single treatment at initial treatment
Azzalure or Dysport: Upper facial lines
Restylane or Emervel filler: Facial tissue augmentation
Restylane Skinbooster: Facial skin rejuvenation
|
Filler as Single Treatment
n=31 Participants
Filler as single treatment at initial treatment
Azzalure or Dysport: Upper facial lines
Restylane or Emervel filler: Facial tissue augmentation
Restylane Skinbooster: Facial skin rejuvenation
|
|---|---|---|
|
Percentage of Subjects With Improvement in Global Facial Aesthetic Appearance
|
66.7 percentage of subjects
|
93.5 percentage of subjects
|
SECONDARY outcome
Timeframe: 1, 7 and 13 monthsPopulation: Six subjects that were assessed differently by all three evaluators were excluded from the analysis. In addition, one subject was excluded from the analysis due to wrong photographs at Month 1.
Subjects showing superior "Global facial aesthetic appearance" at 1, 7 and 13 months. Assessment of global facial aesthetic appearance was based on blinded evaluations of subject's youthful appearance (e.g. lack of facial volume loss, lack of static wrinkles and fine lines, good skin quality, and satisfactory result after aesthetic treatment). The blinded evaluators retrospectively reviewed photographs from visit for each subject and answered the following question: "At which set of photographs does the subject show superior global facial aesthetic appearance?".
Outcome measures
| Measure |
Azzalure/Dysport as Single Treatment
n=25 Participants
Azzalure/Dysport as single treatment at initial treatment
Azzalure or Dysport: Upper facial lines
Restylane or Emervel filler: Facial tissue augmentation
Restylane Skinbooster: Facial skin rejuvenation
|
Filler as Single Treatment
n=28 Participants
Filler as single treatment at initial treatment
Azzalure or Dysport: Upper facial lines
Restylane or Emervel filler: Facial tissue augmentation
Restylane Skinbooster: Facial skin rejuvenation
|
|---|---|---|
|
Percentage of Subjects With Improvement in Global Facial Aesthetic Appearance
Month 7
|
36.0 percentage of subjects
|
35.7 percentage of subjects
|
|
Percentage of Subjects With Improvement in Global Facial Aesthetic Appearance
Month 1
|
4.0 percentage of subjects
|
3.6 percentage of subjects
|
|
Percentage of Subjects With Improvement in Global Facial Aesthetic Appearance
Month 13
|
60.0 percentage of subjects
|
60.7 percentage of subjects
|
SECONDARY outcome
Timeframe: 1, 7, and 13 monthsPopulation: Number of analyzed subjects varied over time due to drop-outs from study. Data not presented "Per Arm", since statistical analysis was only performed on both groups combined after the combination treatments (since the groups receive the exact same treatment during the combination treatment).
The 5-graded GAIS was used to assess the facial aesthetic improvement from Baseline by responding to the question: "How would you describe the subject's global facial aesthetic appearance compared to the photographs taken before treatment at Baseline?". The following rating was used: Very much improved, Much improved, Somewhat improved, No change, or Worse. Criteria for improvement met for those subjects that were assessed as Very much improved, Much improved, or Somewhat improved. GAIS score was assessed by three blinded evaluators at Months 1, 7, and 13 (1 month after single treatment, 1 month after first combined treatment, and 1 month after second combined treatment). The blinded evaluators performed the evaluations retrospectively using 2D-photographs from each follow-up visit and from Baseline (Visit 1).
Outcome measures
| Measure |
Azzalure/Dysport as Single Treatment
n=63 Participants
Azzalure/Dysport as single treatment at initial treatment
Azzalure or Dysport: Upper facial lines
Restylane or Emervel filler: Facial tissue augmentation
Restylane Skinbooster: Facial skin rejuvenation
|
Filler as Single Treatment
Filler as single treatment at initial treatment
Azzalure or Dysport: Upper facial lines
Restylane or Emervel filler: Facial tissue augmentation
Restylane Skinbooster: Facial skin rejuvenation
|
|---|---|---|
|
Number of Subjects Improved on the Global Aesthetic Improvement Scale (GAIS) as Assessed by Blinded Evaluator
Month 1
|
65.1 % participants
Interval 52.0 to 76.7
|
—
|
|
Number of Subjects Improved on the Global Aesthetic Improvement Scale (GAIS) as Assessed by Blinded Evaluator
Month 7
|
90.3 % participants
Interval 80.1 to 96.4
|
—
|
|
Number of Subjects Improved on the Global Aesthetic Improvement Scale (GAIS) as Assessed by Blinded Evaluator
Month 13
|
88.3 % participants
Interval 77.4 to 95.2
|
—
|
SECONDARY outcome
Timeframe: 7 and 13 monthsPopulation: Number of analyzed subjects varied over time due to drop-outs from study.
The subjects were asked to answer the question "How satisfied are you today with the appearance of your face?" with "Very/somewhat satisfied", "Neither/nor", or "Very/somewhat dissatisfied". Satisfied criteria is fulfilled for those subjects that answered ""Very/somewhat satisfied".
Outcome measures
| Measure |
Azzalure/Dysport as Single Treatment
n=31 Participants
Azzalure/Dysport as single treatment at initial treatment
Azzalure or Dysport: Upper facial lines
Restylane or Emervel filler: Facial tissue augmentation
Restylane Skinbooster: Facial skin rejuvenation
|
Filler as Single Treatment
n=31 Participants
Filler as single treatment at initial treatment
Azzalure or Dysport: Upper facial lines
Restylane or Emervel filler: Facial tissue augmentation
Restylane Skinbooster: Facial skin rejuvenation
|
|---|---|---|
|
Number of Participants Satisfied With Facial Appearance
Month 7
|
31 Participants
|
29 Participants
|
|
Number of Participants Satisfied With Facial Appearance
Month 13
|
30 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: 7 and 13 monthsPopulation: Number of analyzed subjects varied over time due to drop-out of study subjects.
The Investigators answered the question "How satisfied are you with the overall facial aesthetic outcome for the subject?" with "Very/somewhat satisfied", "Neither/nor", or "Very/somewhat dissatisfied". Satisfied criteria met for those subjects that the Investigator answered "Very/somewhat satisfied".
Outcome measures
| Measure |
Azzalure/Dysport as Single Treatment
n=31 Participants
Azzalure/Dysport as single treatment at initial treatment
Azzalure or Dysport: Upper facial lines
Restylane or Emervel filler: Facial tissue augmentation
Restylane Skinbooster: Facial skin rejuvenation
|
Filler as Single Treatment
n=31 Participants
Filler as single treatment at initial treatment
Azzalure or Dysport: Upper facial lines
Restylane or Emervel filler: Facial tissue augmentation
Restylane Skinbooster: Facial skin rejuvenation
|
|---|---|---|
|
Number of Participants for Which the Investigator is Satisfied With the Outcome
Month 7
|
31 Participants
|
31 Participants
|
|
Number of Participants for Which the Investigator is Satisfied With the Outcome
Month 13
|
30 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: 7 and 13 monthsPopulation: Number of analyzed subjects was reduced over time due to drop-out of study subjects.
The wrinkle severity of the Azzalure/Dysport treated glabellar lines at maximum frown was evaluated by the Investigator. A validated 5-graded photonumeric grading scale was used, where each severity grade was illustrated by a set of photographs. 0 = No glabella lines 1. = Mild glabella lines 2. = Moderate glabella lines 3. = Severe glabella lines 4. = Very severe glabella lines Improvement means going from higher score to lower score.
Outcome measures
| Measure |
Azzalure/Dysport as Single Treatment
n=31 Participants
Azzalure/Dysport as single treatment at initial treatment
Azzalure or Dysport: Upper facial lines
Restylane or Emervel filler: Facial tissue augmentation
Restylane Skinbooster: Facial skin rejuvenation
|
Filler as Single Treatment
n=31 Participants
Filler as single treatment at initial treatment
Azzalure or Dysport: Upper facial lines
Restylane or Emervel filler: Facial tissue augmentation
Restylane Skinbooster: Facial skin rejuvenation
|
|---|---|---|
|
Percentage of Subjects Improved in Wrinkle Severity Score
Month 7
|
100 percentage of participants
Interval 88.8 to 100.0
|
100 percentage of participants
Interval 88.8 to 100.0
|
|
Percentage of Subjects Improved in Wrinkle Severity Score
Month 13
|
100 percentage of participants
Interval 88.4 to 100.0
|
100 percentage of participants
Interval 88.1 to 100.0
|
SECONDARY outcome
Timeframe: BaselineEvaluation of Azzalure/Dysport (Group A)/Filler (Group B) volume injected at initial single treatment (baseline).
Outcome measures
| Measure |
Azzalure/Dysport as Single Treatment
n=32 Participants
Azzalure/Dysport as single treatment at initial treatment
Azzalure or Dysport: Upper facial lines
Restylane or Emervel filler: Facial tissue augmentation
Restylane Skinbooster: Facial skin rejuvenation
|
Filler as Single Treatment
n=33 Participants
Filler as single treatment at initial treatment
Azzalure or Dysport: Upper facial lines
Restylane or Emervel filler: Facial tissue augmentation
Restylane Skinbooster: Facial skin rejuvenation
|
|---|---|---|
|
Injected Volume of Study Products at Initial Single Treatment
|
118.8 Speywood Units/mL
Standard Deviation 13
|
0.99 Speywood Units/mL
Standard Deviation 0.03
|
Adverse Events
After Single Treatment - Azzalure/Dysport
After Single Treatment - Filler
After 1st Combination Treatment - All Subjects
After 2nd Combination Treatment - All Subjects
Serious adverse events
| Measure |
After Single Treatment - Azzalure/Dysport
n=32 participants at risk
Subjects receiving Azzalure/Dysport as the initial single treatment.
|
After Single Treatment - Filler
n=33 participants at risk
Subjects receiving Filler as the initial single treatment.
|
After 1st Combination Treatment - All Subjects
n=62 participants at risk
Both treatment groups combined, since they received the same treatment during the combination treatment phase.
|
After 2nd Combination Treatment - All Subjects
n=61 participants at risk
Both treatment groups combined, since they received the same treatment during the combination treatment phase.
|
|---|---|---|---|---|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/32 • 18 months
The Arms/Groups are combined for the combination treatment phase, since all subjects received the same treatment during that time.
|
3.0%
1/33 • Number of events 1 • 18 months
The Arms/Groups are combined for the combination treatment phase, since all subjects received the same treatment during that time.
|
0.00%
0/62 • 18 months
The Arms/Groups are combined for the combination treatment phase, since all subjects received the same treatment during that time.
|
0.00%
0/61 • 18 months
The Arms/Groups are combined for the combination treatment phase, since all subjects received the same treatment during that time.
|
Other adverse events
| Measure |
After Single Treatment - Azzalure/Dysport
n=32 participants at risk
Subjects receiving Azzalure/Dysport as the initial single treatment.
|
After Single Treatment - Filler
n=33 participants at risk
Subjects receiving Filler as the initial single treatment.
|
After 1st Combination Treatment - All Subjects
n=62 participants at risk
Both treatment groups combined, since they received the same treatment during the combination treatment phase.
|
After 2nd Combination Treatment - All Subjects
n=61 participants at risk
Both treatment groups combined, since they received the same treatment during the combination treatment phase.
|
|---|---|---|---|---|
|
Nervous system disorders
Headache
|
9.4%
3/32 • Number of events 3 • 18 months
The Arms/Groups are combined for the combination treatment phase, since all subjects received the same treatment during that time.
|
3.0%
1/33 • Number of events 1 • 18 months
The Arms/Groups are combined for the combination treatment phase, since all subjects received the same treatment during that time.
|
6.5%
4/62 • Number of events 4 • 18 months
The Arms/Groups are combined for the combination treatment phase, since all subjects received the same treatment during that time.
|
0.00%
0/61 • 18 months
The Arms/Groups are combined for the combination treatment phase, since all subjects received the same treatment during that time.
|
|
General disorders
Implant site bruising
|
0.00%
0/32 • 18 months
The Arms/Groups are combined for the combination treatment phase, since all subjects received the same treatment during that time.
|
9.1%
3/33 • Number of events 4 • 18 months
The Arms/Groups are combined for the combination treatment phase, since all subjects received the same treatment during that time.
|
24.2%
15/62 • Number of events 25 • 18 months
The Arms/Groups are combined for the combination treatment phase, since all subjects received the same treatment during that time.
|
23.0%
14/61 • Number of events 31 • 18 months
The Arms/Groups are combined for the combination treatment phase, since all subjects received the same treatment during that time.
|
|
General disorders
Implant site swelling
|
0.00%
0/32 • 18 months
The Arms/Groups are combined for the combination treatment phase, since all subjects received the same treatment during that time.
|
0.00%
0/33 • 18 months
The Arms/Groups are combined for the combination treatment phase, since all subjects received the same treatment during that time.
|
4.8%
3/62 • Number of events 5 • 18 months
The Arms/Groups are combined for the combination treatment phase, since all subjects received the same treatment during that time.
|
1.6%
1/61 • Number of events 1 • 18 months
The Arms/Groups are combined for the combination treatment phase, since all subjects received the same treatment during that time.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.2%
2/32 • Number of events 2 • 18 months
The Arms/Groups are combined for the combination treatment phase, since all subjects received the same treatment during that time.
|
0.00%
0/33 • 18 months
The Arms/Groups are combined for the combination treatment phase, since all subjects received the same treatment during that time.
|
0.00%
0/62 • 18 months
The Arms/Groups are combined for the combination treatment phase, since all subjects received the same treatment during that time.
|
0.00%
0/61 • 18 months
The Arms/Groups are combined for the combination treatment phase, since all subjects received the same treatment during that time.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place