Trial Outcomes & Findings for TEOSYAL® RHA Global Action, TEOSYAL® RHA Deep Lines, and Juvéderm® Ultra XC for the Correction of Nasolabial Folds (NCT NCT02195427)
NCT ID: NCT02195427
Last Updated: 2018-04-25
Results Overview
TEOSYAL® RHA GA = TEOSYAL® RHA Global Action TEOSYAL® RHA DL = TEOSYAL® RHA Deep Lines WSRS (Wrinkle Severity Rating Scale) is a validated 5-point scale assessing wrinkle severity with 1 being 'absent' and 5 being 'extreme' BLE = Blinded Live Evaluator
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
148 participants
Primary outcome timeframe
Baseline and 24 weeks after last treatment
Results posted on
2018-04-25
Participant Flow
A total of 148 subjects were randomized to RHA Global Action (GA)/Juvederm (J) (n=74), RHA Deep Lines (DL)/Juvederm (J) (n=74). 26 subjects were randomized to an untreated group (recruited only to avoid Blinded Live Evaluator to be biased so, not presented)
One subject randomized to the RHA GA/J withdrew consent prior to receiving initial treatment reducing the population for this cohort to n=73.
Participant milestones
| Measure |
TEOSYAL RHA Global Action/Juvederm Ultra XC
Split-face injection of TEOSYAL® RHA Global Action into one NLF and Juvederm® Ultra XC into the contralateral NLF. Up to 3.0 mL injected per NLF (mid-dermis to deep-dermis). Touch-up treatment provided at 2 weeks (up to 3.0 mL per NLF).
TEOSYAL® RHA Global Action: A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus equi bacteria, formulated to a concentration of 23 mg/mL and 0.3% w/w lidocaine in a physiologic buffer. It is supplied in individual treatment syringes with 30G1/2" disposable sterile needles.
|
TEOSYAL RHA Deep Lines/Juvederm Ultra XC
Split-face injection of TEOSYAL® RHA Deep Lines into one NLF and Juvederm® Ultra XC into the contralateral NLF. Up to 3.0 mL injected per NLF (mid-dermis to deep-dermis). Touch-up treatment provided at 2 weeks (up to 3.0 mL per NLF).
TEOSYAL® RHA Deep Lines: A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus equi bacteria, formulated to a concentration of 23 mg/mL and 0.3% w/w lidocaine in a physiologic buffer. It is supplied in individual treatment syringes with 27G1/2" disposable sterile needles.
|
|---|---|---|
|
Overall Study
STARTED
|
73
|
74
|
|
Overall Study
N Patients at W24 (Primary Outcome)
|
67
|
62
|
|
Overall Study
N Patients at W36
|
65
|
59
|
|
Overall Study
N Patients at W52
|
63
|
56
|
|
Overall Study
COMPLETED
|
47
|
47
|
|
Overall Study
NOT COMPLETED
|
26
|
27
|
Reasons for withdrawal
| Measure |
TEOSYAL RHA Global Action/Juvederm Ultra XC
Split-face injection of TEOSYAL® RHA Global Action into one NLF and Juvederm® Ultra XC into the contralateral NLF. Up to 3.0 mL injected per NLF (mid-dermis to deep-dermis). Touch-up treatment provided at 2 weeks (up to 3.0 mL per NLF).
TEOSYAL® RHA Global Action: A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus equi bacteria, formulated to a concentration of 23 mg/mL and 0.3% w/w lidocaine in a physiologic buffer. It is supplied in individual treatment syringes with 30G1/2" disposable sterile needles.
|
TEOSYAL RHA Deep Lines/Juvederm Ultra XC
Split-face injection of TEOSYAL® RHA Deep Lines into one NLF and Juvederm® Ultra XC into the contralateral NLF. Up to 3.0 mL injected per NLF (mid-dermis to deep-dermis). Touch-up treatment provided at 2 weeks (up to 3.0 mL per NLF).
TEOSYAL® RHA Deep Lines: A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus equi bacteria, formulated to a concentration of 23 mg/mL and 0.3% w/w lidocaine in a physiologic buffer. It is supplied in individual treatment syringes with 27G1/2" disposable sterile needles.
|
|---|---|---|
|
Overall Study
Did not consent to study extension
|
13
|
9
|
|
Overall Study
Withdrawal by Subject
|
4
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Protocol Violation
|
7
|
14
|
|
Overall Study
Conditional re-treatment at W52
|
2
|
1
|
Baseline Characteristics
TEOSYAL® RHA Global Action, TEOSYAL® RHA Deep Lines, and Juvéderm® Ultra XC for the Correction of Nasolabial Folds
Baseline characteristics by cohort
| Measure |
TEOSYAL RHA Global Action/Juvederm Ultra XC
n=73 Participants
Split-face injection of TEOSYAL® RHA Global Action into one NLF and Juvederm® Ultra XC into the contralateral NLF. Up to 3.0 mL injected per NLF (mid-dermis to deep-dermis). Touch-up treatment provided at 2 weeks (up to 3.0 mL per NLF).
|
TEOSYAL RHA Deep Lines/Juvederm Ultra XC
n=74 Participants
Split-face injection of TEOSYAL® RHA Deep Lines into one NLF and Juvederm® Ultra XC into the contralateral NLF. Up to 3.0 mL injected per NLF (mid-dermis to deep-dermis). Touch-up treatment provided at 2 weeks (up to 3.0 mL per NLF).
|
Total
n=147 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.5 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
55.7 years
STANDARD_DEVIATION 9.4 • n=7 Participants
|
55.6 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
130 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
17 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
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 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
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
59 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 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
|
73 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
147 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
Types I to III
|
45 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
Types IV to VI
|
28 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 24 weeks after last treatmentTEOSYAL® RHA GA = TEOSYAL® RHA Global Action TEOSYAL® RHA DL = TEOSYAL® RHA Deep Lines WSRS (Wrinkle Severity Rating Scale) is a validated 5-point scale assessing wrinkle severity with 1 being 'absent' and 5 being 'extreme' BLE = Blinded Live Evaluator
Outcome measures
| Measure |
TEOSYAL® RHA Global Action
n=67 Participants
Injection of TEOSYAL® RHA Global Action into one NLF
|
Juvéderm® Ultra XC (RHA GA)
n=67 Participants
Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Global Action
|
TEOSYAL® RHA Deep Lines
n=62 Participants
Injection of TEOSYAL® RHA Deep Lines into one NLF
|
Juvéderm® Ultra XC (RHA DL)
n=62 Participants
Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Deep Lines
|
|---|---|---|---|---|
|
Non-inferiority of the Delta of TEOSYAL® RHA GA and TEOSYAL® RHA DL Versus Juvéderm® Ultra XC for the Correction of Moderate to Severe NLFs Based on the Wrinkle Severity Rating Scale (WSRS) Score Assessed by the Blinded Live Evaluator (BLE).
|
-1.16 units on a scale
Interval -1.36 to -0.97
|
-1.13 units on a scale
Interval -1.33 to -0.93
|
-1.32 units on a scale
Interval -1.53 to -1.12
|
-1.23 units on a scale
Interval -1.43 to -1.02
|
SECONDARY outcome
Timeframe: During 14 days after initial treatment (D0) and touch-up (2 weeks)Population: 1 subject randomized to the GA/J cohort received injections with DL/J and was placed in the DL/J cohort for safety evaluation; So: N=75 for DL/J SAFT population and N=72 for GA/J SAFT population. Number of patients for CTR after touch-up treatment are based on number of patients receiving Touch-up treatment (GA N=47/J-GA N=49/DL N=50/J-DL N=53)
The subjects received a diary booklet and instructions for recording his/her observations of the Common Treatment Responses of the study treatments for the first 14 days after each treatment (initial, touch-up). The diary was discussed during each telephone follow-up visit. Subjects should complete the diary at approximately the same time each day (i.e., am or pm). The subject diary captured the following Common Treatment Responses (CTR) that occur following the injection of a dermal filler; specifically, redness, pain, tenderness, firmness, swelling, lumps/bumps, bruising, itching, discoloration, and "other". The 14-day patient CTR diary included a detailed glossary describing all signs/symptoms listed in the diary; an option was provided to rate "other" if the subject experienced a sign/symptom that is not listed. The table presents the number of subjects experiencing at least 1 Common Treatment Response (CTR)
Outcome measures
| Measure |
TEOSYAL® RHA Global Action
n=72 Participants
Injection of TEOSYAL® RHA Global Action into one NLF
|
Juvéderm® Ultra XC (RHA GA)
n=72 Participants
Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Global Action
|
TEOSYAL® RHA Deep Lines
n=75 Participants
Injection of TEOSYAL® RHA Deep Lines into one NLF
|
Juvéderm® Ultra XC (RHA DL)
n=75 Participants
Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Deep Lines
|
|---|---|---|---|---|
|
Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Global Action (GA) and TEOSYAL® RHA Deep Lines (DL) Versus Juvéderm® Ultra XC (J).
Bruising (initial treatment)
|
36 Participants
|
41 Participants
|
42 Participants
|
38 Participants
|
|
Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Global Action (GA) and TEOSYAL® RHA Deep Lines (DL) Versus Juvéderm® Ultra XC (J).
Bruising (Touch-up)
|
15 Participants
|
13 Participants
|
19 Participants
|
20 Participants
|
|
Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Global Action (GA) and TEOSYAL® RHA Deep Lines (DL) Versus Juvéderm® Ultra XC (J).
Itching (Touch-up)
|
5 Participants
|
4 Participants
|
5 Participants
|
5 Participants
|
|
Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Global Action (GA) and TEOSYAL® RHA Deep Lines (DL) Versus Juvéderm® Ultra XC (J).
Redness (initial treatment)
|
45 Participants
|
49 Participants
|
43 Participants
|
42 Participants
|
|
Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Global Action (GA) and TEOSYAL® RHA Deep Lines (DL) Versus Juvéderm® Ultra XC (J).
Redness (Touch-up)
|
15 Participants
|
16 Participants
|
27 Participants
|
25 Participants
|
|
Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Global Action (GA) and TEOSYAL® RHA Deep Lines (DL) Versus Juvéderm® Ultra XC (J).
Swelling (initial treatment)
|
42 Participants
|
45 Participants
|
41 Participants
|
38 Participants
|
|
Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Global Action (GA) and TEOSYAL® RHA Deep Lines (DL) Versus Juvéderm® Ultra XC (J).
Discolouration (initial treatment)
|
24 Participants
|
27 Participants
|
22 Participants
|
22 Participants
|
|
Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Global Action (GA) and TEOSYAL® RHA Deep Lines (DL) Versus Juvéderm® Ultra XC (J).
Discolouration (Touch-up)
|
11 Participants
|
13 Participants
|
10 Participants
|
12 Participants
|
|
Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Global Action (GA) and TEOSYAL® RHA Deep Lines (DL) Versus Juvéderm® Ultra XC (J).
Firmness (initial treatment)
|
46 Participants
|
48 Participants
|
48 Participants
|
45 Participants
|
|
Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Global Action (GA) and TEOSYAL® RHA Deep Lines (DL) Versus Juvéderm® Ultra XC (J).
Firmness (Touch-up)
|
25 Participants
|
20 Participants
|
34 Participants
|
31 Participants
|
|
Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Global Action (GA) and TEOSYAL® RHA Deep Lines (DL) Versus Juvéderm® Ultra XC (J).
Itching (initial treatment)
|
12 Participants
|
15 Participants
|
13 Participants
|
11 Participants
|
|
Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Global Action (GA) and TEOSYAL® RHA Deep Lines (DL) Versus Juvéderm® Ultra XC (J).
Lumps/Bumps (initial treatment)
|
38 Participants
|
37 Participants
|
49 Participants
|
40 Participants
|
|
Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Global Action (GA) and TEOSYAL® RHA Deep Lines (DL) Versus Juvéderm® Ultra XC (J).
Lumps/Bumps (Touch-up)
|
21 Participants
|
17 Participants
|
30 Participants
|
24 Participants
|
|
Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Global Action (GA) and TEOSYAL® RHA Deep Lines (DL) Versus Juvéderm® Ultra XC (J).
Pain (initial treatment)
|
19 Participants
|
16 Participants
|
30 Participants
|
23 Participants
|
|
Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Global Action (GA) and TEOSYAL® RHA Deep Lines (DL) Versus Juvéderm® Ultra XC (J).
Pain (Touch-up)
|
10 Participants
|
9 Participants
|
16 Participants
|
19 Participants
|
|
Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Global Action (GA) and TEOSYAL® RHA Deep Lines (DL) Versus Juvéderm® Ultra XC (J).
Swelling (Touch-up)
|
23 Participants
|
22 Participants
|
31 Participants
|
31 Participants
|
|
Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Global Action (GA) and TEOSYAL® RHA Deep Lines (DL) Versus Juvéderm® Ultra XC (J).
Tenderness (Initial treatment)
|
44 Participants
|
40 Participants
|
44 Participants
|
37 Participants
|
|
Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Global Action (GA) and TEOSYAL® RHA Deep Lines (DL) Versus Juvéderm® Ultra XC (J).
Tenderness (Touch-up)
|
22 Participants
|
18 Participants
|
29 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: During Injection and 5, 15, 30 minutes post-injectionPopulation: 1 subject randomized to the GA/J cohort received injections with DL/J and was placed in the DL/J cohort for safety evaluation; So: N=75 for DL/J SAFT population and N=72 for GA/J SAFT population. Number of patients after touch-up treatment are based on number of patients receiving Touch-up treatment (GA N=47/J-GA N=49/DL N=50/J-DL N=53)
VAS is a 100 mm Visual Analog Scale with 0 meaning no pain and 100 meaning intolerable pain
Outcome measures
| Measure |
TEOSYAL® RHA Global Action
n=72 Participants
Injection of TEOSYAL® RHA Global Action into one NLF
|
Juvéderm® Ultra XC (RHA GA)
n=72 Participants
Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Global Action
|
TEOSYAL® RHA Deep Lines
n=75 Participants
Injection of TEOSYAL® RHA Deep Lines into one NLF
|
Juvéderm® Ultra XC (RHA DL)
n=75 Participants
Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Deep Lines
|
|---|---|---|---|---|
|
Assessment of Injection Site Pain (Visual Analog Scale) of TEOSYAL® RHA Global Action (GA) and TEOSYAL® RHA Deep Lines (DL) Versus Juvéderm® Ultra XC (J).
Touch-up injection mean pain 30 min post-injection
|
1.2 VAS score
Standard Deviation 5.2
|
1.0 VAS score
Standard Deviation 5.0
|
1.5 VAS score
Standard Deviation 4.6
|
1.2 VAS score
Standard Deviation 3.9
|
|
Assessment of Injection Site Pain (Visual Analog Scale) of TEOSYAL® RHA Global Action (GA) and TEOSYAL® RHA Deep Lines (DL) Versus Juvéderm® Ultra XC (J).
Initial injection mean pain during injection
|
15.0 VAS score
Standard Deviation 17.2
|
13.9 VAS score
Standard Deviation 17.4
|
16.7 VAS score
Standard Deviation 17.8
|
14.6 VAS score
Standard Deviation 17.7
|
|
Assessment of Injection Site Pain (Visual Analog Scale) of TEOSYAL® RHA Global Action (GA) and TEOSYAL® RHA Deep Lines (DL) Versus Juvéderm® Ultra XC (J).
Initial injection mean pain 5 min post-injection
|
3.8 VAS score
Standard Deviation 9.1
|
3.9 VAS score
Standard Deviation 9.5
|
3.7 VAS score
Standard Deviation 7.7
|
2.9 VAS score
Standard Deviation 5.1
|
|
Assessment of Injection Site Pain (Visual Analog Scale) of TEOSYAL® RHA Global Action (GA) and TEOSYAL® RHA Deep Lines (DL) Versus Juvéderm® Ultra XC (J).
Initial injection mean pain 15 min post-injection
|
1.1 VAS score
Standard Deviation 3.3
|
1.4 VAS score
Standard Deviation 3.9
|
2.0 VAS score
Standard Deviation 5.5
|
1.4 VAS score
Standard Deviation 3.2
|
|
Assessment of Injection Site Pain (Visual Analog Scale) of TEOSYAL® RHA Global Action (GA) and TEOSYAL® RHA Deep Lines (DL) Versus Juvéderm® Ultra XC (J).
Initial injection mean pain 30 min post-injection
|
0.5 VAS score
Standard Deviation 1.7
|
0.7 VAS score
Standard Deviation 1.9
|
1.0 VAS score
Standard Deviation 3.0
|
0.5 VAS score
Standard Deviation 0.9
|
|
Assessment of Injection Site Pain (Visual Analog Scale) of TEOSYAL® RHA Global Action (GA) and TEOSYAL® RHA Deep Lines (DL) Versus Juvéderm® Ultra XC (J).
Touch-up injection mean pain during injection
|
12.6 VAS score
Standard Deviation 17.5
|
11.8 VAS score
Standard Deviation 14.6
|
15.9 VAS score
Standard Deviation 17.4
|
14.5 VAS score
Standard Deviation 18.4
|
|
Assessment of Injection Site Pain (Visual Analog Scale) of TEOSYAL® RHA Global Action (GA) and TEOSYAL® RHA Deep Lines (DL) Versus Juvéderm® Ultra XC (J).
Touch-up injection mean pain 5 min post-injection
|
3.2 VAS score
Standard Deviation 9.1
|
2.8 VAS score
Standard Deviation 7.3
|
4.6 VAS score
Standard Deviation 9.7
|
3.5 VAS score
Standard Deviation 7.3
|
|
Assessment of Injection Site Pain (Visual Analog Scale) of TEOSYAL® RHA Global Action (GA) and TEOSYAL® RHA Deep Lines (DL) Versus Juvéderm® Ultra XC (J).
Touch-up injection mean pain 15 min post-injection
|
1.7 VAS score
Standard Deviation 7.1
|
1.3 VAS score
Standard Deviation 5.8
|
2.2 VAS score
Standard Deviation 5.2
|
1.9 VAS score
Standard Deviation 4.6
|
SECONDARY outcome
Timeframe: Baseline and Weeks 24, 36, 52, 64Population: Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available (See participant flow)
TEOSYAL® RHA GA = TEOSYAL® RHA Global Action TEOSYAL® RHA DL = TEOSYAL® RHA Deep Lines WSRS (Wrinkle Severity Rating Scale) is a validated 5-point scale assessing wrinkle severity with 1 being 'absent' and 5 being 'extreme' BLE = Blinded Live Evaluator
Outcome measures
| Measure |
TEOSYAL® RHA Global Action
n=67 Participants
Injection of TEOSYAL® RHA Global Action into one NLF
|
Juvéderm® Ultra XC (RHA GA)
n=67 Participants
Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Global Action
|
TEOSYAL® RHA Deep Lines
n=62 Participants
Injection of TEOSYAL® RHA Deep Lines into one NLF
|
Juvéderm® Ultra XC (RHA DL)
n=62 Participants
Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Deep Lines
|
|---|---|---|---|---|
|
Delta of the WSRS Score Between W24,36,52 and Baseline for TEOSYAL® RHA GA Versus Juvéderm® Ultra XC and TEOSYAL® RHA DL Versus Juvéderm® Ultra XC for the Correction of Moderate to Severe NLFs Based on the WSRS Score Assessed by the BLE
W24 Delta from V1
|
-1.16 WSRS Delta from V1
Standard Deviation 0.69
|
-1.13 WSRS Delta from V1
Standard Deviation 0.72
|
-1.32 WSRS Delta from V1
Standard Deviation 0.70
|
-1.23 WSRS Delta from V1
Standard Deviation 0.71
|
|
Delta of the WSRS Score Between W24,36,52 and Baseline for TEOSYAL® RHA GA Versus Juvéderm® Ultra XC and TEOSYAL® RHA DL Versus Juvéderm® Ultra XC for the Correction of Moderate to Severe NLFs Based on the WSRS Score Assessed by the BLE
W36 Delta from V1
|
-1.12 WSRS Delta from V1
Standard Deviation 0.65
|
-1.12 WSRS Delta from V1
Standard Deviation 0.60
|
-1.03 WSRS Delta from V1
Standard Deviation 0.70
|
-0.98 WSRS Delta from V1
Standard Deviation 0.69
|
|
Delta of the WSRS Score Between W24,36,52 and Baseline for TEOSYAL® RHA GA Versus Juvéderm® Ultra XC and TEOSYAL® RHA DL Versus Juvéderm® Ultra XC for the Correction of Moderate to Severe NLFs Based on the WSRS Score Assessed by the BLE
W52 Delta from V1
|
-1.06 WSRS Delta from V1
Standard Deviation 0.60
|
-1.06 WSRS Delta from V1
Standard Deviation 0.65
|
-0.91 WSRS Delta from V1
Standard Deviation 0.77
|
-0.82 WSRS Delta from V1
Standard Deviation 0.74
|
|
Delta of the WSRS Score Between W24,36,52 and Baseline for TEOSYAL® RHA GA Versus Juvéderm® Ultra XC and TEOSYAL® RHA DL Versus Juvéderm® Ultra XC for the Correction of Moderate to Severe NLFs Based on the WSRS Score Assessed by the BLE
W64 Delta fom V1
|
-0.94 WSRS Delta from V1
Standard Deviation 0.57
|
-1.00 WSRS Delta from V1
Standard Deviation 0.63
|
-0.91 WSRS Delta from V1
Standard Deviation 0.72
|
-0.83 WSRS Delta from V1
Standard Deviation 0.67
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 12, 24, 36, 52, 64Population: Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available (See participant flow)
TEOSYAL® RHA GA = TEOSYAL® RHA Global Action TEOSYAL® RHA DL = TEOSYAL® RHA Deep Lines WSRS (Wrinkle Severity Rating Scale) is a validated 5-point scale assessing wrinkle severity with 1 being 'absent' and 5 being 'extreme' TI = Treating Investigator
Outcome measures
| Measure |
TEOSYAL® RHA Global Action
n=67 Participants
Injection of TEOSYAL® RHA Global Action into one NLF
|
Juvéderm® Ultra XC (RHA GA)
n=67 Participants
Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Global Action
|
TEOSYAL® RHA Deep Lines
n=62 Participants
Injection of TEOSYAL® RHA Deep Lines into one NLF
|
Juvéderm® Ultra XC (RHA DL)
n=62 Participants
Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Deep Lines
|
|---|---|---|---|---|
|
Delta of the WSRS Score Between W2,4,12,24,36,52,64 and Baseline for TEOSYAL® RHA GA Versus Juvéderm® Ultra XC and TEOSYAL® RHA Deep Lines Versus Juvéderm® Ultra XC for the Correction of Moderate to Severe NLFs Based on the WSRS Score Assessed by the TI
W2 Delta from V1
|
-1.49 WSRS Delta from V1
Standard Deviation 0.61
|
-1.34 WSRS Delta from V1
Standard Deviation 0.73
|
-1.45 WSRS Delta from V1
Standard Deviation 0.64
|
-1.31 WSRS Delta from V1
Standard Deviation 0.59
|
|
Delta of the WSRS Score Between W2,4,12,24,36,52,64 and Baseline for TEOSYAL® RHA GA Versus Juvéderm® Ultra XC and TEOSYAL® RHA Deep Lines Versus Juvéderm® Ultra XC for the Correction of Moderate to Severe NLFs Based on the WSRS Score Assessed by the TI
W4 Delta from V1
|
-1.66 WSRS Delta from V1
Standard Deviation 0.64
|
-1.69 WSRS Delta from V1
Standard Deviation 0.64
|
-1.84 WSRS Delta from V1
Standard Deviation 0.45
|
-1.77 WSRS Delta from V1
Standard Deviation 0.50
|
|
Delta of the WSRS Score Between W2,4,12,24,36,52,64 and Baseline for TEOSYAL® RHA GA Versus Juvéderm® Ultra XC and TEOSYAL® RHA Deep Lines Versus Juvéderm® Ultra XC for the Correction of Moderate to Severe NLFs Based on the WSRS Score Assessed by the TI
W36 Delta from V1
|
-1.23 WSRS Delta from V1
Standard Deviation 0.61
|
-1.17 WSRS Delta from V1
Standard Deviation 0.72
|
-1.08 WSRS Delta from V1
Standard Deviation 0.65
|
-1.03 WSRS Delta from V1
Standard Deviation 0.67
|
|
Delta of the WSRS Score Between W2,4,12,24,36,52,64 and Baseline for TEOSYAL® RHA GA Versus Juvéderm® Ultra XC and TEOSYAL® RHA Deep Lines Versus Juvéderm® Ultra XC for the Correction of Moderate to Severe NLFs Based on the WSRS Score Assessed by the TI
W52 Delta from V1
|
-1.24 WSRS Delta from V1
Standard Deviation 0.64
|
-1.16 WSRS Delta from V1
Standard Deviation 0.63
|
-1.07 WSRS Delta from V1
Standard Deviation 0.68
|
-0.93 WSRS Delta from V1
Standard Deviation 0.57
|
|
Delta of the WSRS Score Between W2,4,12,24,36,52,64 and Baseline for TEOSYAL® RHA GA Versus Juvéderm® Ultra XC and TEOSYAL® RHA Deep Lines Versus Juvéderm® Ultra XC for the Correction of Moderate to Severe NLFs Based on the WSRS Score Assessed by the TI
W12 Delta from V1
|
-1.52 WSRS Delta from V1
Standard Deviation 0.69
|
-1.32 WSRS Delta from V1
Standard Deviation 0.77
|
-1.65 WSRS Delta from V1
Standard Deviation 0.55
|
-1.58 WSRS Delta from V1
Standard Deviation 0.56
|
|
Delta of the WSRS Score Between W2,4,12,24,36,52,64 and Baseline for TEOSYAL® RHA GA Versus Juvéderm® Ultra XC and TEOSYAL® RHA Deep Lines Versus Juvéderm® Ultra XC for the Correction of Moderate to Severe NLFs Based on the WSRS Score Assessed by the TI
W24 Delta from V1
|
-1.33 WSRS Delta from V1
Standard Deviation 0.59
|
-1.25 WSRS Delta from V1
Standard Deviation 0.70
|
-1.55 WSRS Delta from V1
Standard Deviation 0.59
|
-1.39 WSRS Delta from V1
Standard Deviation 0.55
|
|
Delta of the WSRS Score Between W2,4,12,24,36,52,64 and Baseline for TEOSYAL® RHA GA Versus Juvéderm® Ultra XC and TEOSYAL® RHA Deep Lines Versus Juvéderm® Ultra XC for the Correction of Moderate to Severe NLFs Based on the WSRS Score Assessed by the TI
W64 Delta from V1
|
-1.09 WSRS Delta from V1
Standard Deviation 0.58
|
-0.98 WSRS Delta from V1
Standard Deviation 0.61
|
-0.98 WSRS Delta from V1
Standard Deviation 0.57
|
-0.89 WSRS Delta from V1
Standard Deviation 0.63
|
SECONDARY outcome
Timeframe: Baseline and Weeks 24, 36, 52, 64Population: Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available (See participant flow)
A responder correspond to a subject with an intra-individual improvement of at least one grade in the WSRS compared to baseline
Outcome measures
| Measure |
TEOSYAL® RHA Global Action
n=67 Participants
Injection of TEOSYAL® RHA Global Action into one NLF
|
Juvéderm® Ultra XC (RHA GA)
n=67 Participants
Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Global Action
|
TEOSYAL® RHA Deep Lines
n=62 Participants
Injection of TEOSYAL® RHA Deep Lines into one NLF
|
Juvéderm® Ultra XC (RHA DL)
n=62 Participants
Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Deep Lines
|
|---|---|---|---|---|
|
Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the WSRS Compared to Baseline Assessed by the BLE
W52
|
85.5 percentage of responders
Interval 74.2 to 93.1
|
82.3 percentage of responders
Interval 70.5 to 90.8
|
75.0 percentage of responders
Interval 61.6 to 85.6
|
69.6 percentage of responders
Interval 55.9 to 81.2
|
|
Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the WSRS Compared to Baseline Assessed by the BLE
W24
|
83.6 percentage of responders
Interval 72.5 to 91.5
|
82.1 percentage of responders
Interval 70.8 to 90.4
|
91.9 percentage of responders
Interval 82.2 to 97.3
|
88.7 percentage of responders
Interval 78.1 to 95.3
|
|
Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the WSRS Compared to Baseline Assessed by the BLE
W36
|
86.2 percentage of responders
Interval 75.3 to 93.5
|
87.7 percentage of responders
Interval 77.2 to 94.5
|
82.8 percentage of responders
Interval 70.6 to 91.4
|
79.3 percentage of responders
Interval 66.7 to 88.8
|
|
Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the WSRS Compared to Baseline Assessed by the BLE
W64
|
80.9 percentage of responders
Interval 66.7 to 90.6
|
80.9 percentage of responders
Interval 66.7 to 90.9
|
78.7 percentage of responders
Interval 64.3 to 89.3
|
72.3 percentage of responders
Interval 57.4 to 84.4
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 12, 24, 36, 52, 64Population: Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available (See participant flow)
A responder correspond to a subject with an intra-individual improvement of at least one grade in the WSRS compared to baseline
Outcome measures
| Measure |
TEOSYAL® RHA Global Action
n=67 Participants
Injection of TEOSYAL® RHA Global Action into one NLF
|
Juvéderm® Ultra XC (RHA GA)
n=67 Participants
Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Global Action
|
TEOSYAL® RHA Deep Lines
n=62 Participants
Injection of TEOSYAL® RHA Deep Lines into one NLF
|
Juvéderm® Ultra XC (RHA DL)
n=62 Participants
Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Deep Lines
|
|---|---|---|---|---|
|
Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the WSRS Compared to Baseline Assessed by the TI
W2
|
98.5 percentage of responders
Interval 92.0 to 100.0
|
91.0 percentage of responders
Interval 81.5 to 96.6
|
95.2 percentage of responders
Interval 86.5 to 99.0
|
93.6 percentage of responders
Interval 84.3 to 98.2
|
|
Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the WSRS Compared to Baseline Assessed by the TI
W4
|
98.5 percentage of responders
Interval 91.7 to 100.0
|
98.5 percentage of responders
Interval 91.7 to 100.0
|
100.0 percentage of responders
Interval 94.1 to 100.0
|
100.0 percentage of responders
Interval 94.1 to 100.0
|
|
Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the WSRS Compared to Baseline Assessed by the TI
W12
|
95.4 percentage of responders
Interval 87.1 to 99.0
|
87.7 percentage of responders
Interval 77.2 to 94.5
|
100.0 percentage of responders
Interval 94.2 to 100.0
|
100.0 percentage of responders
Interval 94.2 to 100.0
|
|
Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the WSRS Compared to Baseline Assessed by the TI
W24
|
94.0 percentage of responders
Interval 85.4 to 98.4
|
86.6 percentage of responders
Interval 76.0 to 93.7
|
96.8 percentage of responders
Interval 88.8 to 99.6
|
98.4 percentage of responders
Interval 91.3 to 100.0
|
|
Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the WSRS Compared to Baseline Assessed by the TI
W36
|
90.8 percentage of responders
Interval 81.0 to 96.5
|
83.1 percentage of responders
Interval 71.7 to 91.2
|
83.1 percentage of responders
Interval 71.0 to 91.6
|
79.7 percentage of responders
Interval 67.2 to 89.0
|
|
Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the WSRS Compared to Baseline Assessed by the TI
W52
|
88.9 percentage of responders
Interval 78.4 to 95.4
|
87.3 percentage of responders
Interval 76.5 to 94.4
|
80.4 percentage of responders
Interval 67.6 to 89.8
|
80.4 percentage of responders
Interval 67.6 to 89.8
|
|
Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the WSRS Compared to Baseline Assessed by the TI
W64
|
87.2 percentage of responders
Interval 74.3 to 95.2
|
80.9 percentage of responders
Interval 66.7 to 90.0
|
83.0 percentage of responders
Interval 69.2 to 92.4
|
74.5 percentage of responders
Interval 59.7 to 86.1
|
SECONDARY outcome
Timeframe: Weeks 24, 36, 52, 64Population: Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available (See participant flow)
Global Aesthetic Improvement (GAI) is a subjective 5-grade scale comprised of "much improved, improved, no change, worse, and much worse" that evaluate the aesthetic improvement from baseline. GAI was assessed using the baseline photograph. Each side of the face was assessed independently.
Outcome measures
| Measure |
TEOSYAL® RHA Global Action
n=67 Participants
Injection of TEOSYAL® RHA Global Action into one NLF
|
Juvéderm® Ultra XC (RHA GA)
n=67 Participants
Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Global Action
|
TEOSYAL® RHA Deep Lines
n=62 Participants
Injection of TEOSYAL® RHA Deep Lines into one NLF
|
Juvéderm® Ultra XC (RHA DL)
n=62 Participants
Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Deep Lines
|
|---|---|---|---|---|
|
Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE).
W24
|
61 Participants
|
59 Participants
|
59 Participants
|
58 Participants
|
|
Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE).
W36
|
60 Participants
|
61 Participants
|
53 Participants
|
50 Participants
|
|
Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE).
W52
|
57 Participants
|
54 Participants
|
46 Participants
|
44 Participants
|
|
Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE).
W64
|
41 Participants
|
39 Participants
|
40 Participants
|
37 Participants
|
SECONDARY outcome
Timeframe: Weeks 4, 12, 24, 36, 52, 64Population: Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available (See participant flow)
Global Aesthetic Improvement (GAI) is a subjective 5-grade scale comprised of "much improved, improved, no change, worse, and much worse" that evaluate the aesthetic improvement from baseline. GAI was assessed using the baseline photograph. Subjects will be instructed: "Use a mirror to compare your face to the photograph provided to you and rate the degree of aesthetic improvement by using the following scale". Each side of the face was assessed independently.
Outcome measures
| Measure |
TEOSYAL® RHA Global Action
n=67 Participants
Injection of TEOSYAL® RHA Global Action into one NLF
|
Juvéderm® Ultra XC (RHA GA)
n=67 Participants
Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Global Action
|
TEOSYAL® RHA Deep Lines
n=62 Participants
Injection of TEOSYAL® RHA Deep Lines into one NLF
|
Juvéderm® Ultra XC (RHA DL)
n=62 Participants
Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Deep Lines
|
|---|---|---|---|---|
|
Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either "Much Improved" or "Improved") on GAI Scale.
W12
|
60 Participants
|
59 Participants
|
59 Participants
|
60 Participants
|
|
Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either "Much Improved" or "Improved") on GAI Scale.
W24
|
59 Participants
|
59 Participants
|
55 Participants
|
55 Participants
|
|
Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either "Much Improved" or "Improved") on GAI Scale.
W52
|
55 Participants
|
53 Participants
|
50 Participants
|
49 Participants
|
|
Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either "Much Improved" or "Improved") on GAI Scale.
W4
|
64 Participants
|
63 Participants
|
59 Participants
|
59 Participants
|
|
Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either "Much Improved" or "Improved") on GAI Scale.
W36
|
59 Participants
|
58 Participants
|
54 Participants
|
53 Participants
|
|
Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either "Much Improved" or "Improved") on GAI Scale.
W64
|
44 Participants
|
45 Participants
|
43 Participants
|
41 Participants
|
SECONDARY outcome
Timeframe: Immediately post-injection, and weeks 2, 4, 12, 24, 36, 52, 64Population: Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available (See participant flow)
The FACE-Q measures the experience and outcomes of aesthetic facial procedures from the patient's perspective. FACE-Q questionnaire is composed of 5 questions with a score linked to answers (1 being 'Not at all' and 4 being 'Extremely'). The subject was instructed as follows: "These questions ask about how you look right now. With your nasolabial folds in mind (the deep lines that run downward from the sides of your nose), in the past week, how much have you been bothered by:", and provided response. * How deep your nasolabial fold are? * How your nasolabial folds look when your face is relaxed (still)? * How old your nasolabial folds make you look? * How your nasolabial folds look when you smile? * How your nasolabial folds look compared with other people your age? To calculate the FACE-Q, outcomes from all 5 questions were pooled and adapted to a scale to 100 units. Data were also transformed so that higher scores reflected a beneficial outcome.
Outcome measures
| Measure |
TEOSYAL® RHA Global Action
n=67 Participants
Injection of TEOSYAL® RHA Global Action into one NLF
|
Juvéderm® Ultra XC (RHA GA)
n=67 Participants
Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Global Action
|
TEOSYAL® RHA Deep Lines
n=62 Participants
Injection of TEOSYAL® RHA Deep Lines into one NLF
|
Juvéderm® Ultra XC (RHA DL)
n=62 Participants
Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Deep Lines
|
|---|---|---|---|---|
|
Subject's Perception of Treatment Effectiveness as Per the FACE-Q (NLF Domain) Questionnaire
pre-treatment
|
24.7 units on a scale
Standard Deviation 17.7
|
25.2 units on a scale
Standard Deviation 16.5
|
29.1 units on a scale
Standard Deviation 17.0
|
27.7 units on a scale
Standard Deviation 17.8
|
|
Subject's Perception of Treatment Effectiveness as Per the FACE-Q (NLF Domain) Questionnaire
W2
|
70.3 units on a scale
Standard Deviation 22.7
|
69.0 units on a scale
Standard Deviation 22.2
|
67.4 units on a scale
Standard Deviation 25.5
|
66.9 units on a scale
Standard Deviation 25.3
|
|
Subject's Perception of Treatment Effectiveness as Per the FACE-Q (NLF Domain) Questionnaire
W4
|
76.7 units on a scale
Standard Deviation 22.1
|
75.6 units on a scale
Standard Deviation 22.0
|
77.5 units on a scale
Standard Deviation 20.4
|
78.0 units on a scale
Standard Deviation 20.4
|
|
Subject's Perception of Treatment Effectiveness as Per the FACE-Q (NLF Domain) Questionnaire
W12
|
74.5 units on a scale
Standard Deviation 23.5
|
73.1 units on a scale
Standard Deviation 23.7
|
77.5 units on a scale
Standard Deviation 21.8
|
77.2 units on a scale
Standard Deviation 21.9
|
|
Subject's Perception of Treatment Effectiveness as Per the FACE-Q (NLF Domain) Questionnaire
W24
|
64.6 units on a scale
Standard Deviation 24.8
|
62.9 units on a scale
Standard Deviation 24.5
|
64.8 units on a scale
Standard Deviation 24.5
|
66.2 units on a scale
Standard Deviation 23.7
|
|
Subject's Perception of Treatment Effectiveness as Per the FACE-Q (NLF Domain) Questionnaire
W52
|
63.6 units on a scale
Standard Deviation 29.3
|
61.8 units on a scale
Standard Deviation 30.0
|
63.0 units on a scale
Standard Deviation 27.4
|
60.5 units on a scale
Standard Deviation 27.6
|
|
Subject's Perception of Treatment Effectiveness as Per the FACE-Q (NLF Domain) Questionnaire
W64
|
58.4 units on a scale
Standard Deviation 21.9
|
59.5 units on a scale
Standard Deviation 22.4
|
64.1 units on a scale
Standard Deviation 25.2
|
62.7 units on a scale
Standard Deviation 24.9
|
|
Subject's Perception of Treatment Effectiveness as Per the FACE-Q (NLF Domain) Questionnaire
W36
|
64.0 units on a scale
Standard Deviation 25.2
|
61.4 units on a scale
Standard Deviation 25.1
|
66.0 units on a scale
Standard Deviation 26.4
|
65.3 units on a scale
Standard Deviation 25.2
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 12, 24, 36, 52, 64Population: Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available (See participant flow)
Subjective 5-point scale with 1 being 'very satisfied' and 5 being 'very dissatisfied'
Outcome measures
| Measure |
TEOSYAL® RHA Global Action
n=67 Participants
Injection of TEOSYAL® RHA Global Action into one NLF
|
Juvéderm® Ultra XC (RHA GA)
n=67 Participants
Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Global Action
|
TEOSYAL® RHA Deep Lines
n=62 Participants
Injection of TEOSYAL® RHA Deep Lines into one NLF
|
Juvéderm® Ultra XC (RHA DL)
n=62 Participants
Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Deep Lines
|
|---|---|---|---|---|
|
Subject's Satisfaction Score
W2
|
1.58 units on a scale
Standard Deviation 0.72
|
1.57 units on a scale
Standard Deviation 0.74
|
1.87 units on a scale
Standard Deviation 0.78
|
1.81 units on a scale
Standard Deviation 0.70
|
|
Subject's Satisfaction Score
W36
|
1.66 units on a scale
Standard Deviation 0.76
|
1.69 units on a scale
Standard Deviation 0.75
|
1.56 units on a scale
Standard Deviation 0.82
|
1.63 units on a scale
Standard Deviation 0.83
|
|
Subject's Satisfaction Score
W52
|
1.47 units on a scale
Standard Deviation 0.69
|
1.58 units on a scale
Standard Deviation 0.78
|
1.55 units on a scale
Standard Deviation 0.93
|
1.66 units on a scale
Standard Deviation 0.82
|
|
Subject's Satisfaction Score
W4
|
1.29 units on a scale
Standard Deviation 0.49
|
1.29 units on a scale
Standard Deviation 0.49
|
1.43 units on a scale
Standard Deviation 0.67
|
1.34 units on a scale
Standard Deviation 0.54
|
|
Subject's Satisfaction Score
W12
|
1.46 units on a scale
Standard Deviation 0.64
|
1.55 units on a scale
Standard Deviation 0.71
|
1.50 units on a scale
Standard Deviation 0.76
|
1.50 units on a scale
Standard Deviation 0.70
|
|
Subject's Satisfaction Score
W24
|
1.73 units on a scale
Standard Deviation 0.73
|
1.75 units on a scale
Standard Deviation 0.75
|
1.63 units on a scale
Standard Deviation 0.83
|
1.55 units on a scale
Standard Deviation 0.74
|
|
Subject's Satisfaction Score
W64
|
1.68 units on a scale
Standard Deviation 0.75
|
1.66 units on a scale
Standard Deviation 0.70
|
1.36 units on a scale
Standard Deviation 0.67
|
1.45 units on a scale
Standard Deviation 0.75
|
SECONDARY outcome
Timeframe: Week 2Outcome measures
| Measure |
TEOSYAL® RHA Global Action
n=67 Participants
Injection of TEOSYAL® RHA Global Action into one NLF
|
Juvéderm® Ultra XC (RHA GA)
n=67 Participants
Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Global Action
|
TEOSYAL® RHA Deep Lines
n=62 Participants
Injection of TEOSYAL® RHA Deep Lines into one NLF
|
Juvéderm® Ultra XC (RHA DL)
n=62 Participants
Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Deep Lines
|
|---|---|---|---|---|
|
Volume to Obtain Optimal Cosmetic Result (Initial Treatment + Touch-up)
|
1.54 mL
Standard Deviation 0.66
|
1.30 mL
Standard Deviation 0.53
|
1.52 mL
Standard Deviation 0.62
|
1.30 mL
Standard Deviation 0.55
|
SECONDARY outcome
Timeframe: Week 2Outcome measures
| Measure |
TEOSYAL® RHA Global Action
n=67 Participants
Injection of TEOSYAL® RHA Global Action into one NLF
|
Juvéderm® Ultra XC (RHA GA)
n=67 Participants
Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Global Action
|
TEOSYAL® RHA Deep Lines
n=62 Participants
Injection of TEOSYAL® RHA Deep Lines into one NLF
|
Juvéderm® Ultra XC (RHA DL)
n=62 Participants
Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Deep Lines
|
|---|---|---|---|---|
|
Number of Subjects Receiving Touch-up Treatment.
|
43 Participants
|
45 Participants
|
45 Participants
|
47 Participants
|
SECONDARY outcome
Timeframe: Weeks 24, 36, 52, 64Population: Numbers of patients analyzed correspond to patients that have completed the visits (See participant flow)
Outcome measures
| Measure |
TEOSYAL® RHA Global Action
n=67 Participants
Injection of TEOSYAL® RHA Global Action into one NLF
|
Juvéderm® Ultra XC (RHA GA)
n=67 Participants
Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Global Action
|
TEOSYAL® RHA Deep Lines
n=62 Participants
Injection of TEOSYAL® RHA Deep Lines into one NLF
|
Juvéderm® Ultra XC (RHA DL)
n=62 Participants
Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Deep Lines
|
|---|---|---|---|---|
|
Number of Subjects Receiving Re-treatment
W24
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Receiving Re-treatment
W36
|
3 Participants
|
3 Participants
|
5 Participants
|
5 Participants
|
|
Number of Subjects Receiving Re-treatment
W52
|
9 Participants
|
11 Participants
|
9 Participants
|
9 Participants
|
|
Number of Subjects Receiving Re-treatment
W64
|
42 Participants
|
43 Participants
|
39 Participants
|
38 Participants
|
Adverse Events
TEOSYAL® RHA Global Action
Serious events: 2 serious events
Other events: 39 other events
Deaths: 0 deaths
Juvéderm® Ultra XC (RHA GA)
Serious events: 2 serious events
Other events: 36 other events
Deaths: 0 deaths
TEOSYAL® RHA Deep Lines
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Juvéderm® Ultra XC (RHA DL)
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TEOSYAL® RHA Global Action
n=72 participants at risk；n=75 participants at risk
Injection of TEOSYAL® RHA Global Action into one NLF
|
Juvéderm® Ultra XC (RHA GA)
n=72 participants at risk；n=75 participants at risk
Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Global Action
|
TEOSYAL® RHA Deep Lines
n=75 participants at risk
Injection of TEOSYAL® RHA Deep Lines into one NLF
|
Juvéderm® Ultra XC (RHA DL)
n=75 participants at risk
Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Deep Lines
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Gastric Ulcer
|
1.3%
1/75 • 64 weeks or 68 weeks for patients receiving a re-treatment at W64
The TI assessed all AEs and recorded details of seriousness, severity, duration, and action taken with study device, and relationship to the study device. 1 subject randomized to the RHA Global Action/Juverderm cohort received injections with RHA Deep Lines/Juvederm and was placed in the RHA Deep Lines/Juvederm cohort for safety evaluation; So: N=75 for RHA Deep Lines/Juvederm SAFT population and N=72 for RHA Global Action/Juvederm SAFT population.
|
1.3%
1/75 • 64 weeks or 68 weeks for patients receiving a re-treatment at W64
The TI assessed all AEs and recorded details of seriousness, severity, duration, and action taken with study device, and relationship to the study device. 1 subject randomized to the RHA Global Action/Juverderm cohort received injections with RHA Deep Lines/Juvederm and was placed in the RHA Deep Lines/Juvederm cohort for safety evaluation; So: N=75 for RHA Deep Lines/Juvederm SAFT population and N=72 for RHA Global Action/Juvederm SAFT population.
|
0.00%
0/75 • 64 weeks or 68 weeks for patients receiving a re-treatment at W64
The TI assessed all AEs and recorded details of seriousness, severity, duration, and action taken with study device, and relationship to the study device. 1 subject randomized to the RHA Global Action/Juverderm cohort received injections with RHA Deep Lines/Juvederm and was placed in the RHA Deep Lines/Juvederm cohort for safety evaluation; So: N=75 for RHA Deep Lines/Juvederm SAFT population and N=72 for RHA Global Action/Juvederm SAFT population.
|
0.00%
0/75 • 64 weeks or 68 weeks for patients receiving a re-treatment at W64
The TI assessed all AEs and recorded details of seriousness, severity, duration, and action taken with study device, and relationship to the study device. 1 subject randomized to the RHA Global Action/Juverderm cohort received injections with RHA Deep Lines/Juvederm and was placed in the RHA Deep Lines/Juvederm cohort for safety evaluation; So: N=75 for RHA Deep Lines/Juvederm SAFT population and N=72 for RHA Global Action/Juvederm SAFT population.
|
|
Gastrointestinal disorders
Gatric Ulcer Perforation
|
1.3%
1/75 • 64 weeks or 68 weeks for patients receiving a re-treatment at W64
The TI assessed all AEs and recorded details of seriousness, severity, duration, and action taken with study device, and relationship to the study device. 1 subject randomized to the RHA Global Action/Juverderm cohort received injections with RHA Deep Lines/Juvederm and was placed in the RHA Deep Lines/Juvederm cohort for safety evaluation; So: N=75 for RHA Deep Lines/Juvederm SAFT population and N=72 for RHA Global Action/Juvederm SAFT population.
|
1.3%
1/75 • 64 weeks or 68 weeks for patients receiving a re-treatment at W64
The TI assessed all AEs and recorded details of seriousness, severity, duration, and action taken with study device, and relationship to the study device. 1 subject randomized to the RHA Global Action/Juverderm cohort received injections with RHA Deep Lines/Juvederm and was placed in the RHA Deep Lines/Juvederm cohort for safety evaluation; So: N=75 for RHA Deep Lines/Juvederm SAFT population and N=72 for RHA Global Action/Juvederm SAFT population.
|
0.00%
0/75 • 64 weeks or 68 weeks for patients receiving a re-treatment at W64
The TI assessed all AEs and recorded details of seriousness, severity, duration, and action taken with study device, and relationship to the study device. 1 subject randomized to the RHA Global Action/Juverderm cohort received injections with RHA Deep Lines/Juvederm and was placed in the RHA Deep Lines/Juvederm cohort for safety evaluation; So: N=75 for RHA Deep Lines/Juvederm SAFT population and N=72 for RHA Global Action/Juvederm SAFT population.
|
0.00%
0/75 • 64 weeks or 68 weeks for patients receiving a re-treatment at W64
The TI assessed all AEs and recorded details of seriousness, severity, duration, and action taken with study device, and relationship to the study device. 1 subject randomized to the RHA Global Action/Juverderm cohort received injections with RHA Deep Lines/Juvederm and was placed in the RHA Deep Lines/Juvederm cohort for safety evaluation; So: N=75 for RHA Deep Lines/Juvederm SAFT population and N=72 for RHA Global Action/Juvederm SAFT population.
|
Other adverse events
| Measure |
TEOSYAL® RHA Global Action
n=72 participants at risk；n=75 participants at risk
Injection of TEOSYAL® RHA Global Action into one NLF
|
Juvéderm® Ultra XC (RHA GA)
n=72 participants at risk；n=75 participants at risk
Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Global Action
|
TEOSYAL® RHA Deep Lines
n=75 participants at risk
Injection of TEOSYAL® RHA Deep Lines into one NLF
|
Juvéderm® Ultra XC (RHA DL)
n=75 participants at risk
Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Deep Lines
|
|---|---|---|---|---|
|
General disorders
Injection site firmness
|
27.8%
20/72 • Number of events 25 • 64 weeks or 68 weeks for patients receiving a re-treatment at W64
The TI assessed all AEs and recorded details of seriousness, severity, duration, and action taken with study device, and relationship to the study device. 1 subject randomized to the RHA Global Action/Juverderm cohort received injections with RHA Deep Lines/Juvederm and was placed in the RHA Deep Lines/Juvederm cohort for safety evaluation; So: N=75 for RHA Deep Lines/Juvederm SAFT population and N=72 for RHA Global Action/Juvederm SAFT population.
|
23.6%
17/72 • Number of events 20 • 64 weeks or 68 weeks for patients receiving a re-treatment at W64
The TI assessed all AEs and recorded details of seriousness, severity, duration, and action taken with study device, and relationship to the study device. 1 subject randomized to the RHA Global Action/Juverderm cohort received injections with RHA Deep Lines/Juvederm and was placed in the RHA Deep Lines/Juvederm cohort for safety evaluation; So: N=75 for RHA Deep Lines/Juvederm SAFT population and N=72 for RHA Global Action/Juvederm SAFT population.
|
25.3%
19/75 • Number of events 25 • 64 weeks or 68 weeks for patients receiving a re-treatment at W64
The TI assessed all AEs and recorded details of seriousness, severity, duration, and action taken with study device, and relationship to the study device. 1 subject randomized to the RHA Global Action/Juverderm cohort received injections with RHA Deep Lines/Juvederm and was placed in the RHA Deep Lines/Juvederm cohort for safety evaluation; So: N=75 for RHA Deep Lines/Juvederm SAFT population and N=72 for RHA Global Action/Juvederm SAFT population.
|
12.0%
9/75 • Number of events 12 • 64 weeks or 68 weeks for patients receiving a re-treatment at W64
The TI assessed all AEs and recorded details of seriousness, severity, duration, and action taken with study device, and relationship to the study device. 1 subject randomized to the RHA Global Action/Juverderm cohort received injections with RHA Deep Lines/Juvederm and was placed in the RHA Deep Lines/Juvederm cohort for safety evaluation; So: N=75 for RHA Deep Lines/Juvederm SAFT population and N=72 for RHA Global Action/Juvederm SAFT population.
|
|
General disorders
Injection site lumps/bumps
|
20.8%
15/72 • Number of events 18 • 64 weeks or 68 weeks for patients receiving a re-treatment at W64
The TI assessed all AEs and recorded details of seriousness, severity, duration, and action taken with study device, and relationship to the study device. 1 subject randomized to the RHA Global Action/Juverderm cohort received injections with RHA Deep Lines/Juvederm and was placed in the RHA Deep Lines/Juvederm cohort for safety evaluation; So: N=75 for RHA Deep Lines/Juvederm SAFT population and N=72 for RHA Global Action/Juvederm SAFT population.
|
9.7%
7/72 • Number of events 9 • 64 weeks or 68 weeks for patients receiving a re-treatment at W64
The TI assessed all AEs and recorded details of seriousness, severity, duration, and action taken with study device, and relationship to the study device. 1 subject randomized to the RHA Global Action/Juverderm cohort received injections with RHA Deep Lines/Juvederm and was placed in the RHA Deep Lines/Juvederm cohort for safety evaluation; So: N=75 for RHA Deep Lines/Juvederm SAFT population and N=72 for RHA Global Action/Juvederm SAFT population.
|
22.7%
17/75 • Number of events 22 • 64 weeks or 68 weeks for patients receiving a re-treatment at W64
The TI assessed all AEs and recorded details of seriousness, severity, duration, and action taken with study device, and relationship to the study device. 1 subject randomized to the RHA Global Action/Juverderm cohort received injections with RHA Deep Lines/Juvederm and was placed in the RHA Deep Lines/Juvederm cohort for safety evaluation; So: N=75 for RHA Deep Lines/Juvederm SAFT population and N=72 for RHA Global Action/Juvederm SAFT population.
|
18.7%
14/75 • Number of events 16 • 64 weeks or 68 weeks for patients receiving a re-treatment at W64
The TI assessed all AEs and recorded details of seriousness, severity, duration, and action taken with study device, and relationship to the study device. 1 subject randomized to the RHA Global Action/Juverderm cohort received injections with RHA Deep Lines/Juvederm and was placed in the RHA Deep Lines/Juvederm cohort for safety evaluation; So: N=75 for RHA Deep Lines/Juvederm SAFT population and N=72 for RHA Global Action/Juvederm SAFT population.
|
|
General disorders
Injection site haematoma
|
6.9%
5/72 • Number of events 6 • 64 weeks or 68 weeks for patients receiving a re-treatment at W64
The TI assessed all AEs and recorded details of seriousness, severity, duration, and action taken with study device, and relationship to the study device. 1 subject randomized to the RHA Global Action/Juverderm cohort received injections with RHA Deep Lines/Juvederm and was placed in the RHA Deep Lines/Juvederm cohort for safety evaluation; So: N=75 for RHA Deep Lines/Juvederm SAFT population and N=72 for RHA Global Action/Juvederm SAFT population.
|
5.6%
4/72 • Number of events 5 • 64 weeks or 68 weeks for patients receiving a re-treatment at W64
The TI assessed all AEs and recorded details of seriousness, severity, duration, and action taken with study device, and relationship to the study device. 1 subject randomized to the RHA Global Action/Juverderm cohort received injections with RHA Deep Lines/Juvederm and was placed in the RHA Deep Lines/Juvederm cohort for safety evaluation; So: N=75 for RHA Deep Lines/Juvederm SAFT population and N=72 for RHA Global Action/Juvederm SAFT population.
|
6.7%
5/75 • Number of events 6 • 64 weeks or 68 weeks for patients receiving a re-treatment at W64
The TI assessed all AEs and recorded details of seriousness, severity, duration, and action taken with study device, and relationship to the study device. 1 subject randomized to the RHA Global Action/Juverderm cohort received injections with RHA Deep Lines/Juvederm and was placed in the RHA Deep Lines/Juvederm cohort for safety evaluation; So: N=75 for RHA Deep Lines/Juvederm SAFT population and N=72 for RHA Global Action/Juvederm SAFT population.
|
6.7%
5/75 • Number of events 6 • 64 weeks or 68 weeks for patients receiving a re-treatment at W64
The TI assessed all AEs and recorded details of seriousness, severity, duration, and action taken with study device, and relationship to the study device. 1 subject randomized to the RHA Global Action/Juverderm cohort received injections with RHA Deep Lines/Juvederm and was placed in the RHA Deep Lines/Juvederm cohort for safety evaluation; So: N=75 for RHA Deep Lines/Juvederm SAFT population and N=72 for RHA Global Action/Juvederm SAFT population.
|
|
General disorders
Tenderness
|
9.7%
7/72 • Number of events 8 • 64 weeks or 68 weeks for patients receiving a re-treatment at W64
The TI assessed all AEs and recorded details of seriousness, severity, duration, and action taken with study device, and relationship to the study device. 1 subject randomized to the RHA Global Action/Juverderm cohort received injections with RHA Deep Lines/Juvederm and was placed in the RHA Deep Lines/Juvederm cohort for safety evaluation; So: N=75 for RHA Deep Lines/Juvederm SAFT population and N=72 for RHA Global Action/Juvederm SAFT population.
|
4.2%
3/72 • Number of events 3 • 64 weeks or 68 weeks for patients receiving a re-treatment at W64
The TI assessed all AEs and recorded details of seriousness, severity, duration, and action taken with study device, and relationship to the study device. 1 subject randomized to the RHA Global Action/Juverderm cohort received injections with RHA Deep Lines/Juvederm and was placed in the RHA Deep Lines/Juvederm cohort for safety evaluation; So: N=75 for RHA Deep Lines/Juvederm SAFT population and N=72 for RHA Global Action/Juvederm SAFT population.
|
13.3%
10/75 • Number of events 11 • 64 weeks or 68 weeks for patients receiving a re-treatment at W64
The TI assessed all AEs and recorded details of seriousness, severity, duration, and action taken with study device, and relationship to the study device. 1 subject randomized to the RHA Global Action/Juverderm cohort received injections with RHA Deep Lines/Juvederm and was placed in the RHA Deep Lines/Juvederm cohort for safety evaluation; So: N=75 for RHA Deep Lines/Juvederm SAFT population and N=72 for RHA Global Action/Juvederm SAFT population.
|
5.3%
4/75 • Number of events 4 • 64 weeks or 68 weeks for patients receiving a re-treatment at W64
The TI assessed all AEs and recorded details of seriousness, severity, duration, and action taken with study device, and relationship to the study device. 1 subject randomized to the RHA Global Action/Juverderm cohort received injections with RHA Deep Lines/Juvederm and was placed in the RHA Deep Lines/Juvederm cohort for safety evaluation; So: N=75 for RHA Deep Lines/Juvederm SAFT population and N=72 for RHA Global Action/Juvederm SAFT population.
|
|
General disorders
Injection site discolouration
|
4.2%
3/72 • Number of events 3 • 64 weeks or 68 weeks for patients receiving a re-treatment at W64
The TI assessed all AEs and recorded details of seriousness, severity, duration, and action taken with study device, and relationship to the study device. 1 subject randomized to the RHA Global Action/Juverderm cohort received injections with RHA Deep Lines/Juvederm and was placed in the RHA Deep Lines/Juvederm cohort for safety evaluation; So: N=75 for RHA Deep Lines/Juvederm SAFT population and N=72 for RHA Global Action/Juvederm SAFT population.
|
6.9%
5/72 • Number of events 5 • 64 weeks or 68 weeks for patients receiving a re-treatment at W64
The TI assessed all AEs and recorded details of seriousness, severity, duration, and action taken with study device, and relationship to the study device. 1 subject randomized to the RHA Global Action/Juverderm cohort received injections with RHA Deep Lines/Juvederm and was placed in the RHA Deep Lines/Juvederm cohort for safety evaluation; So: N=75 for RHA Deep Lines/Juvederm SAFT population and N=72 for RHA Global Action/Juvederm SAFT population.
|
5.3%
4/75 • Number of events 4 • 64 weeks or 68 weeks for patients receiving a re-treatment at W64
The TI assessed all AEs and recorded details of seriousness, severity, duration, and action taken with study device, and relationship to the study device. 1 subject randomized to the RHA Global Action/Juverderm cohort received injections with RHA Deep Lines/Juvederm and was placed in the RHA Deep Lines/Juvederm cohort for safety evaluation; So: N=75 for RHA Deep Lines/Juvederm SAFT population and N=72 for RHA Global Action/Juvederm SAFT population.
|
5.3%
4/75 • Number of events 4 • 64 weeks or 68 weeks for patients receiving a re-treatment at W64
The TI assessed all AEs and recorded details of seriousness, severity, duration, and action taken with study device, and relationship to the study device. 1 subject randomized to the RHA Global Action/Juverderm cohort received injections with RHA Deep Lines/Juvederm and was placed in the RHA Deep Lines/Juvederm cohort for safety evaluation; So: N=75 for RHA Deep Lines/Juvederm SAFT population and N=72 for RHA Global Action/Juvederm SAFT population.
|
|
General disorders
Injection site pain
|
5.6%
4/72 • Number of events 4 • 64 weeks or 68 weeks for patients receiving a re-treatment at W64
The TI assessed all AEs and recorded details of seriousness, severity, duration, and action taken with study device, and relationship to the study device. 1 subject randomized to the RHA Global Action/Juverderm cohort received injections with RHA Deep Lines/Juvederm and was placed in the RHA Deep Lines/Juvederm cohort for safety evaluation; So: N=75 for RHA Deep Lines/Juvederm SAFT population and N=72 for RHA Global Action/Juvederm SAFT population.
|
5.6%
4/72 • Number of events 4 • 64 weeks or 68 weeks for patients receiving a re-treatment at W64
The TI assessed all AEs and recorded details of seriousness, severity, duration, and action taken with study device, and relationship to the study device. 1 subject randomized to the RHA Global Action/Juverderm cohort received injections with RHA Deep Lines/Juvederm and was placed in the RHA Deep Lines/Juvederm cohort for safety evaluation; So: N=75 for RHA Deep Lines/Juvederm SAFT population and N=72 for RHA Global Action/Juvederm SAFT population.
|
2.7%
2/75 • Number of events 2 • 64 weeks or 68 weeks for patients receiving a re-treatment at W64
The TI assessed all AEs and recorded details of seriousness, severity, duration, and action taken with study device, and relationship to the study device. 1 subject randomized to the RHA Global Action/Juverderm cohort received injections with RHA Deep Lines/Juvederm and was placed in the RHA Deep Lines/Juvederm cohort for safety evaluation; So: N=75 for RHA Deep Lines/Juvederm SAFT population and N=72 for RHA Global Action/Juvederm SAFT population.
|
2.7%
2/75 • Number of events 2 • 64 weeks or 68 weeks for patients receiving a re-treatment at W64
The TI assessed all AEs and recorded details of seriousness, severity, duration, and action taken with study device, and relationship to the study device. 1 subject randomized to the RHA Global Action/Juverderm cohort received injections with RHA Deep Lines/Juvederm and was placed in the RHA Deep Lines/Juvederm cohort for safety evaluation; So: N=75 for RHA Deep Lines/Juvederm SAFT population and N=72 for RHA Global Action/Juvederm SAFT population.
|
|
General disorders
Injection site swelling
|
8.3%
6/72 • Number of events 7 • 64 weeks or 68 weeks for patients receiving a re-treatment at W64
The TI assessed all AEs and recorded details of seriousness, severity, duration, and action taken with study device, and relationship to the study device. 1 subject randomized to the RHA Global Action/Juverderm cohort received injections with RHA Deep Lines/Juvederm and was placed in the RHA Deep Lines/Juvederm cohort for safety evaluation; So: N=75 for RHA Deep Lines/Juvederm SAFT population and N=72 for RHA Global Action/Juvederm SAFT population.
|
4.2%
3/72 • Number of events 4 • 64 weeks or 68 weeks for patients receiving a re-treatment at W64
The TI assessed all AEs and recorded details of seriousness, severity, duration, and action taken with study device, and relationship to the study device. 1 subject randomized to the RHA Global Action/Juverderm cohort received injections with RHA Deep Lines/Juvederm and was placed in the RHA Deep Lines/Juvederm cohort for safety evaluation; So: N=75 for RHA Deep Lines/Juvederm SAFT population and N=72 for RHA Global Action/Juvederm SAFT population.
|
12.0%
9/75 • Number of events 11 • 64 weeks or 68 weeks for patients receiving a re-treatment at W64
The TI assessed all AEs and recorded details of seriousness, severity, duration, and action taken with study device, and relationship to the study device. 1 subject randomized to the RHA Global Action/Juverderm cohort received injections with RHA Deep Lines/Juvederm and was placed in the RHA Deep Lines/Juvederm cohort for safety evaluation; So: N=75 for RHA Deep Lines/Juvederm SAFT population and N=72 for RHA Global Action/Juvederm SAFT population.
|
6.7%
5/75 • Number of events 7 • 64 weeks or 68 weeks for patients receiving a re-treatment at W64
The TI assessed all AEs and recorded details of seriousness, severity, duration, and action taken with study device, and relationship to the study device. 1 subject randomized to the RHA Global Action/Juverderm cohort received injections with RHA Deep Lines/Juvederm and was placed in the RHA Deep Lines/Juvederm cohort for safety evaluation; So: N=75 for RHA Deep Lines/Juvederm SAFT population and N=72 for RHA Global Action/Juvederm SAFT population.
|
|
General disorders
Injection site erythema
|
2.8%
2/72 • Number of events 2 • 64 weeks or 68 weeks for patients receiving a re-treatment at W64
The TI assessed all AEs and recorded details of seriousness, severity, duration, and action taken with study device, and relationship to the study device. 1 subject randomized to the RHA Global Action/Juverderm cohort received injections with RHA Deep Lines/Juvederm and was placed in the RHA Deep Lines/Juvederm cohort for safety evaluation; So: N=75 for RHA Deep Lines/Juvederm SAFT population and N=72 for RHA Global Action/Juvederm SAFT population.
|
5.6%
4/72 • Number of events 4 • 64 weeks or 68 weeks for patients receiving a re-treatment at W64
The TI assessed all AEs and recorded details of seriousness, severity, duration, and action taken with study device, and relationship to the study device. 1 subject randomized to the RHA Global Action/Juverderm cohort received injections with RHA Deep Lines/Juvederm and was placed in the RHA Deep Lines/Juvederm cohort for safety evaluation; So: N=75 for RHA Deep Lines/Juvederm SAFT population and N=72 for RHA Global Action/Juvederm SAFT population.
|
6.7%
5/75 • Number of events 7 • 64 weeks or 68 weeks for patients receiving a re-treatment at W64
The TI assessed all AEs and recorded details of seriousness, severity, duration, and action taken with study device, and relationship to the study device. 1 subject randomized to the RHA Global Action/Juverderm cohort received injections with RHA Deep Lines/Juvederm and was placed in the RHA Deep Lines/Juvederm cohort for safety evaluation; So: N=75 for RHA Deep Lines/Juvederm SAFT population and N=72 for RHA Global Action/Juvederm SAFT population.
|
6.7%
5/75 • Number of events 7 • 64 weeks or 68 weeks for patients receiving a re-treatment at W64
The TI assessed all AEs and recorded details of seriousness, severity, duration, and action taken with study device, and relationship to the study device. 1 subject randomized to the RHA Global Action/Juverderm cohort received injections with RHA Deep Lines/Juvederm and was placed in the RHA Deep Lines/Juvederm cohort for safety evaluation; So: N=75 for RHA Deep Lines/Juvederm SAFT population and N=72 for RHA Global Action/Juvederm SAFT population.
|
|
General disorders
Injection site pruritus
|
5.6%
4/72 • Number of events 5 • 64 weeks or 68 weeks for patients receiving a re-treatment at W64
The TI assessed all AEs and recorded details of seriousness, severity, duration, and action taken with study device, and relationship to the study device. 1 subject randomized to the RHA Global Action/Juverderm cohort received injections with RHA Deep Lines/Juvederm and was placed in the RHA Deep Lines/Juvederm cohort for safety evaluation; So: N=75 for RHA Deep Lines/Juvederm SAFT population and N=72 for RHA Global Action/Juvederm SAFT population.
|
4.2%
3/72 • Number of events 4 • 64 weeks or 68 weeks for patients receiving a re-treatment at W64
The TI assessed all AEs and recorded details of seriousness, severity, duration, and action taken with study device, and relationship to the study device. 1 subject randomized to the RHA Global Action/Juverderm cohort received injections with RHA Deep Lines/Juvederm and was placed in the RHA Deep Lines/Juvederm cohort for safety evaluation; So: N=75 for RHA Deep Lines/Juvederm SAFT population and N=72 for RHA Global Action/Juvederm SAFT population.
|
1.3%
1/75 • Number of events 1 • 64 weeks or 68 weeks for patients receiving a re-treatment at W64
The TI assessed all AEs and recorded details of seriousness, severity, duration, and action taken with study device, and relationship to the study device. 1 subject randomized to the RHA Global Action/Juverderm cohort received injections with RHA Deep Lines/Juvederm and was placed in the RHA Deep Lines/Juvederm cohort for safety evaluation; So: N=75 for RHA Deep Lines/Juvederm SAFT population and N=72 for RHA Global Action/Juvederm SAFT population.
|
0.00%
0/75 • 64 weeks or 68 weeks for patients receiving a re-treatment at W64
The TI assessed all AEs and recorded details of seriousness, severity, duration, and action taken with study device, and relationship to the study device. 1 subject randomized to the RHA Global Action/Juverderm cohort received injections with RHA Deep Lines/Juvederm and was placed in the RHA Deep Lines/Juvederm cohort for safety evaluation; So: N=75 for RHA Deep Lines/Juvederm SAFT population and N=72 for RHA Global Action/Juvederm SAFT population.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60