Trial Outcomes & Findings for Safety and Efficacy of Treatment With Azzalure, Restylane/Emervel Filler and Restylane Skinbooster (NCT NCT02297503)
NCT ID: NCT02297503
Last Updated: 2022-08-26
Results Overview
To evaluate "Global facial aesthetic appearance" at 7 months compared to at 1 month, blinded evaluator review of photographs.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
61 participants
Primary outcome timeframe
7 months
Results posted on
2022-08-26
Participant Flow
Participant milestones
| Measure |
Azzalure Alone as Initial Treatment
Azzalure alone as single treatment at initial treatment followed by two combined treatments with Azzalure, HA filler and Skinboosters at Month 6 and Month 12.
|
Filler Alone as Initial Treatment
HA filler alone as single treatment at initial treatment followed by two combined treatments with Azzalure, HA filler and Skinboosters at Month 6 and Month 12.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
31
|
|
Overall Study
Initial Single Treatment
|
29
|
31
|
|
Overall Study
First Combined Treatment
|
28
|
28
|
|
Overall Study
Second Combined Treatment
|
28
|
28
|
|
Overall Study
COMPLETED
|
28
|
27
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
| Measure |
Azzalure Alone as Initial Treatment
Azzalure alone as single treatment at initial treatment followed by two combined treatments with Azzalure, HA filler and Skinboosters at Month 6 and Month 12.
|
Filler Alone as Initial Treatment
HA filler alone as single treatment at initial treatment followed by two combined treatments with Azzalure, HA filler and Skinboosters at Month 6 and Month 12.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Pregnancy
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Medical reason
|
0
|
1
|
Baseline Characteristics
Data on ethnicity only collected for the Swedish site.
Baseline characteristics by cohort
| Measure |
Azzalure Alone as Initial Treatment
n=29 Participants
Azzalulre alone as single treatment at initial treatment followed by two combined treatments with Azzalure, HA filler and Skinboosters at Month 6 and Month 12.
|
Filler Alone as Initial Treatment
n=31 Participants
Filler alone as single treatment at initial treatment followed by two combined treatments with Azzalure, HA filler and Skinboosters at Month 6 and Month 12.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.9 years
n=29 Participants
|
43.6 years
n=31 Participants
|
44.7 years
n=60 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=29 Participants
|
30 Participants
n=31 Participants
|
59 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=29 Participants
|
1 Participants
n=31 Participants
|
1 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
White
|
11 Participants
n=11 Participants • Data on ethnicity only collected for the Swedish site.
|
11 Participants
n=11 Participants • Data on ethnicity only collected for the Swedish site.
|
22 Participants
n=22 Participants • Data on ethnicity only collected for the Swedish site.
|
|
Smoking
Smoker
|
9 participants
n=29 Participants
|
10 participants
n=31 Participants
|
19 participants
n=60 Participants
|
|
Smoking
Non smoker
|
20 participants
n=29 Participants
|
21 participants
n=31 Participants
|
41 participants
n=60 Participants
|
PRIMARY outcome
Timeframe: 7 monthsTo evaluate "Global facial aesthetic appearance" at 7 months compared to at 1 month, blinded evaluator review of photographs.
Outcome measures
| Measure |
Azzalure Alone as Initial Treatment
n=27 Participants
Subjects receiving Azzalure as initial treatment
|
Filler Alone as Initial Treatment
n=27 Participants
Subjects receiving HA filler as initial treatment.
|
|---|---|---|
|
Number of Subjects With Improvement in Global Facial Aesthetic Appearance at 7 Months (Review of Photographs)
|
20 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: 1, 7 and 13 monthsPopulation: Incorrectly taken photographs for six participants were excluded from analysis. Additionally two participants excluded because they were assessed different by all three evaluators.
To evaluate "Global facial aesthetic appearance" at 1, 7 and 13 months, blinded evaluator review of photographs from the respective visits.
Outcome measures
| Measure |
Azzalure Alone as Initial Treatment
n=23 Participants
Subjects receiving Azzalure as initial treatment
|
Filler Alone as Initial Treatment
n=25 Participants
Subjects receiving HA filler as initial treatment.
|
|---|---|---|
|
Number of Subjects With Improvement in Global Facial Aesthetic Appearance at 1, 7 and 13 Months (Review of Photographs)
Superior Month 13
|
13 Participants
|
14 Participants
|
|
Number of Subjects With Improvement in Global Facial Aesthetic Appearance at 1, 7 and 13 Months (Review of Photographs)
Superior Month 1
|
5 Participants
|
0 Participants
|
|
Number of Subjects With Improvement in Global Facial Aesthetic Appearance at 1, 7 and 13 Months (Review of Photographs)
Superior Month 7
|
5 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Month 1, Month 7, and Month 13Population: Number of analyzed subjects decreased over time due to drop-out of study subjects. 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 is 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 scale grades are Very much improved, Much improved, Somewhat improved, No change, Worse. Improved subjects are those graded as Very much improved, Much improved, and Somewhat improved.
Outcome measures
| Measure |
Azzalure Alone as Initial Treatment
n=60 Participants
Subjects receiving Azzalure as initial treatment
|
Filler Alone as Initial Treatment
Subjects receiving HA filler as initial treatment.
|
|---|---|---|
|
Number of Participants Improved on the Global Aesthetic Improvement Scale (GAIS) as Assessed by Blinded Evaluator
Improved Month 1
|
35 participants
|
—
|
|
Number of Participants Improved on the Global Aesthetic Improvement Scale (GAIS) as Assessed by Blinded Evaluator
Improved Month 7
|
42 participants
|
—
|
|
Number of Participants Improved on the Global Aesthetic Improvement Scale (GAIS) as Assessed by Blinded Evaluator
Improved Month 13
|
47 participants
|
—
|
SECONDARY outcome
Timeframe: Month 7 and Month 13Subjects answered the question "How satisfied are you today with the appearance of your face?" with "Very/somewhat satisfied", "Neither/nor", or "Very/somewhat dissatisfied". Number of subjects satisfied are those that answered "Very/somewhat satisfied".
Outcome measures
| Measure |
Azzalure Alone as Initial Treatment
n=28 Participants
Subjects receiving Azzalure as initial treatment
|
Filler Alone as Initial Treatment
n=28 Participants
Subjects receiving HA filler as initial treatment.
|
|---|---|---|
|
Number of Subjects Satisfied With Overall Facial Appearance (Questionnaire)
Satisfied Month 7
|
23 participants
|
26 participants
|
|
Number of Subjects Satisfied With Overall Facial Appearance (Questionnaire)
Satisfied Month 13
|
24 participants
|
27 participants
|
SECONDARY outcome
Timeframe: Month 7 and Month 13The Investigator 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 is met for those subjects that the Investigator answered "Very/somewhat satisfied".
Outcome measures
| Measure |
Azzalure Alone as Initial Treatment
n=28 Participants
Subjects receiving Azzalure as initial treatment
|
Filler Alone as Initial Treatment
n=28 Participants
Subjects receiving HA filler as initial treatment.
|
|---|---|---|
|
Number of Subjects for Which the Investigator is Satisfied With Overall Facial Aesthetic Outcome
Satisfied Month 7
|
28 participants
|
28 participants
|
|
Number of Subjects for Which the Investigator is Satisfied With Overall Facial Aesthetic Outcome
Satisfied Month 13
|
28 participants
|
28 participants
|
SECONDARY outcome
Timeframe: Month 7 and Month 13The wrinkle severity of the glabellar lines at maximum frown was evaluated by the investigator at baseline before first treatment and at follow-up visits. Validated photonumeric grading scales were used where each severity grade is illustrated by a set of photographs. The investigator performed the assessment live or by using 2D photographs from the present visit, together with the respective photo guide: 0 No glabella lines, 1 Mild glabella lines, 2 Moderate glabella lines, 3 Severe glabella lines, 4 Very severe glabella lines. Improved criteria is thus fulfilled for subjects receiving a lower score compared to baseline.
Outcome measures
| Measure |
Azzalure Alone as Initial Treatment
n=28 Participants
Subjects receiving Azzalure as initial treatment
|
Filler Alone as Initial Treatment
n=28 Participants
Subjects receiving HA filler as initial treatment.
|
|---|---|---|
|
Number of Participants Who Had Improvement in Wrinkle Severity Score of Treated Glabellar Lines (Validated Photo Scales)
Improved Month 7
|
27 participants
|
28 participants
|
|
Number of Participants Who Had Improvement in Wrinkle Severity Score of Treated Glabellar Lines (Validated Photo Scales)
Improved Month 13
|
27 participants
|
28 participants
|
SECONDARY outcome
Timeframe: 1 and 7 months, and 1 and 13 monthsPopulation: Five participants excluded from analysis due to incorrectly taken photographs.
To evaluate First impression and perceived age of subjects by evaluation of photos. Change between timepoints are reported. A negative value indicates that the participant is assessed to be younger at the specified visit compared to the assessment made at 1 month after single treatment.
Outcome measures
| Measure |
Azzalure Alone as Initial Treatment
n=27 Participants
Subjects receiving Azzalure as initial treatment
|
Filler Alone as Initial Treatment
n=28 Participants
Subjects receiving HA filler as initial treatment.
|
|---|---|---|
|
Change in Perceived Age of Subjects
Difference Month 7/Month 1
|
-1.7 years
Standard Deviation 4.0
|
-1.9 years
Standard Deviation 2.9
|
|
Change in Perceived Age of Subjects
Differerence Month 13/Month 1
|
-1.9 years
Standard Deviation 4.7
|
-2.4 years
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: Initial single treatment (baseline), first combined treatment (Month 6), and second combined treatment (Month 12)Population: For the initial single treatment, only the "Filler alone as initial treatment" participants received filler. At the two combination treatments, all subjects received filler. Data from the "Filler alone as initial treatment" participants are presented for the single treatment while data for all subjects are presented for the combination treatments.
To evaluate the filler volume injected at initial single treatment and at following repeated combined treatment
Outcome measures
| Measure |
Azzalure Alone as Initial Treatment
n=31 Participants
Subjects receiving Azzalure as initial treatment
|
Filler Alone as Initial Treatment
n=56 Participants
Subjects receiving HA filler as initial treatment.
|
|---|---|---|
|
Injected Filler Volume
Single and first combined treatment
|
0.98 mL
Standard Deviation 0.06
|
1.92 mL
Standard Deviation 0.23
|
|
Injected Filler Volume
Second combined treatment
|
—
|
1.72 mL
Standard Deviation 0.50
|
SECONDARY outcome
Timeframe: 0-18 monthsPopulation: Safety population
To evaluate safety throughout the study period
Outcome measures
| Measure |
Azzalure Alone as Initial Treatment
n=29 Participants
Subjects receiving Azzalure as initial treatment
|
Filler Alone as Initial Treatment
n=31 Participants
Subjects receiving HA filler as initial treatment.
|
|---|---|---|
|
Adverse Event Reporting
|
36 Treatment related AEs
|
26 Treatment related AEs
|
Adverse Events
Group A (Azzalure): After Single Treatment
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Group B (Filler): After Single Treatment
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Group A: After 1st Combined Treatment
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Group B: After 1st Combined Treatment
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Group A: After 2nd Combined Treatment
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Group B: After 2nd Combined Treatment
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group A (Azzalure): After Single Treatment
n=29 participants at risk
Group A received Azzalure alone as initial single treatment, and thereafter two combined treatments. Events reported in this section occurred after the single treatment was given but before the 1st combined treatment was given.
|
Group B (Filler): After Single Treatment
n=31 participants at risk
Group B received filler alone as initial single treatment, and thereafter two combined treatments. Events reported in this section occurred after the single treatment was given but before the 1st combined treatment was given.
|
Group A: After 1st Combined Treatment
n=28 participants at risk
Group A received Azzalure alone as initial single treatment, and thereafter two combined treatments. Events reported in this section occurred after the 1st combined treatment was given.
|
Group B: After 1st Combined Treatment
n=28 participants at risk
Group B received filler alone as initial single treatment, and thereafter two combined treatments. Events reported in this section occurred after the 1st combined treatment was given.
|
Group A: After 2nd Combined Treatment
n=28 participants at risk
Group A received Azzalure alone as initial single treatment, and thereafter two combined treatments. Events reported in this section occurred after the 2nd combined treatment was given.
|
Group B: After 2nd Combined Treatment
n=28 participants at risk
Group B received filler alone as initial single treatment, and thereafter two combined treatments.Events reported in this section occurred after the 2nd combined treatment was given.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/29
|
3.2%
1/31 • Number of events 1
|
0.00%
0/28
|
0.00%
0/28
|
0.00%
0/28
|
0.00%
0/28
|
Other adverse events
| Measure |
Group A (Azzalure): After Single Treatment
n=29 participants at risk
Group A received Azzalure alone as initial single treatment, and thereafter two combined treatments. Events reported in this section occurred after the single treatment was given but before the 1st combined treatment was given.
|
Group B (Filler): After Single Treatment
n=31 participants at risk
Group B received filler alone as initial single treatment, and thereafter two combined treatments. Events reported in this section occurred after the single treatment was given but before the 1st combined treatment was given.
|
Group A: After 1st Combined Treatment
n=28 participants at risk
Group A received Azzalure alone as initial single treatment, and thereafter two combined treatments. Events reported in this section occurred after the 1st combined treatment was given.
|
Group B: After 1st Combined Treatment
n=28 participants at risk
Group B received filler alone as initial single treatment, and thereafter two combined treatments. Events reported in this section occurred after the 1st combined treatment was given.
|
Group A: After 2nd Combined Treatment
n=28 participants at risk
Group A received Azzalure alone as initial single treatment, and thereafter two combined treatments. Events reported in this section occurred after the 2nd combined treatment was given.
|
Group B: After 2nd Combined Treatment
n=28 participants at risk
Group B received filler alone as initial single treatment, and thereafter two combined treatments.Events reported in this section occurred after the 2nd combined treatment was given.
|
|---|---|---|---|---|---|---|
|
General disorders
Implant site bruising
|
0.00%
0/29
|
0.00%
0/31
|
25.0%
7/28 • Number of events 14
|
14.3%
4/28 • Number of events 8
|
17.9%
5/28 • Number of events 8
|
14.3%
4/28 • Number of events 6
|
|
General disorders
Implant site oedema
|
0.00%
0/29
|
0.00%
0/31
|
0.00%
0/28
|
10.7%
3/28 • Number of events 5
|
0.00%
0/28
|
0.00%
0/28
|
|
Nervous system disorders
VII nerve paralysis
|
0.00%
0/29
|
0.00%
0/31
|
0.00%
0/28
|
3.6%
1/28 • Number of events 2
|
0.00%
0/28
|
0.00%
0/28
|
|
General disorders
Haematoma
|
0.00%
0/29
|
3.2%
1/31 • Number of events 2
|
10.7%
3/28 • Number of events 5
|
3.6%
1/28 • Number of events 1
|
7.1%
2/28 • Number of events 2
|
0.00%
0/28
|
|
Infections and infestations
Bronchitis
|
0.00%
0/29
|
0.00%
0/31
|
0.00%
0/28
|
3.6%
1/28 • Number of events 1
|
3.6%
1/28 • Number of events 1
|
3.6%
1/28 • Number of events 1
|
|
General disorders
Inflammatory reaction
|
0.00%
0/29
|
0.00%
0/31
|
3.6%
1/28 • Number of events 2
|
0.00%
0/28
|
0.00%
0/28
|
0.00%
0/28
|
|
Nervous system disorders
Headache
|
0.00%
0/29
|
3.2%
1/31 • Number of events 1
|
0.00%
0/28
|
0.00%
0/28
|
0.00%
0/28
|
0.00%
0/28
|
|
Infections and infestations
Sinusitis
|
0.00%
0/29
|
3.2%
1/31 • Number of events 1
|
3.6%
1/28 • Number of events 1
|
0.00%
0/28
|
3.6%
1/28 • Number of events 1
|
3.6%
1/28 • Number of events 1
|
|
Infections and infestations
Influenza
|
3.4%
1/29 • Number of events 1
|
0.00%
0/31
|
0.00%
0/28
|
7.1%
2/28 • Number of events 2
|
0.00%
0/28
|
3.6%
1/28 • Number of events 1
|
|
General disorders
Swelling
|
0.00%
0/29
|
0.00%
0/31
|
7.1%
2/28 • Number of events 3
|
3.6%
1/28 • Number of events 1
|
0.00%
0/28
|
3.6%
1/28 • Number of events 1
|
|
General disorders
Lump
|
0.00%
0/29
|
0.00%
0/31
|
3.6%
1/28 • Number of events 1
|
0.00%
0/28
|
3.6%
1/28 • Number of events 1
|
0.00%
0/28
|
|
Renal and urinary disorders
Nephritic colic
|
0.00%
0/29
|
3.2%
1/31 • Number of events 1
|
0.00%
0/28
|
0.00%
0/28
|
0.00%
0/28
|
0.00%
0/28
|
|
Infections and infestations
Tooth infection
|
0.00%
0/29
|
0.00%
0/31
|
0.00%
0/28
|
0.00%
0/28
|
0.00%
0/28
|
3.6%
1/28 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
0.00%
0/29
|
0.00%
0/31
|
0.00%
0/28
|
3.6%
1/28 • Number of events 1
|
0.00%
0/28
|
0.00%
0/28
|
|
General disorders
Fatigue
|
0.00%
0/29
|
0.00%
0/31
|
3.6%
1/28 • Number of events 1
|
0.00%
0/28
|
0.00%
0/28
|
0.00%
0/28
|
|
Infections and infestations
Cystitis
|
0.00%
0/29
|
0.00%
0/31
|
3.6%
1/28 • Number of events 1
|
0.00%
0/28
|
0.00%
0/28
|
0.00%
0/28
|
|
Infections and infestations
Common cold
|
0.00%
0/29
|
0.00%
0/31
|
7.1%
2/28 • Number of events 2
|
7.1%
2/28 • Number of events 2
|
0.00%
0/28
|
0.00%
0/28
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place