Trial Outcomes & Findings for TEOSYAL® RHA Ultra Deep and Perlane-L® for the Correction of Nasolabial Folds (NCT NCT02253147)
NCT ID: NCT02253147
Last Updated: 2018-03-27
Results Overview
WSRS (Wrinkle Severity Rating Scale) is a validated 5-point scale with 1 being 'absent' and 5 being 'extreme'. BLE =Blinded Live Evaluator
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
140 participants
Primary outcome timeframe
Baseline and 24 weeks after last treatment
Results posted on
2018-03-27
Participant Flow
A total of 120 were randomized for a split-face injection of RHA Ultra Deep and Perlane-L. 20 subjects were randomized to an untreated group (recruited only to avoid Blinded Live Evaluator to be biased so, not presented)
2 subjects randomized to the RHA UD/Perlane discontinued participation prior to receiving study treatment (N=118) 2 subjects randomized to the untreated group received injections with RHA UD/Perlane. These subjects were placed in the SAFT population for safety evaluations (SAFT population n=120)
Participant milestones
| Measure |
TEOSYAL® RHA Ultra Deep / Perlane-L®
Split-face injection of TEOSYAL® RHA Ultra Deep into one NLF and Perlane-L® into the contralateral NLF. Up to 3.0 mL injected per NLF (deep-dermis to superficial subcutaneous). Touch-up treatment provided at 2 weeks (up to 3.0 mL per NLF).
TEOSYAL® RHA Ultra Deep: 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 27G½" disposable sterile needles.
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|---|---|
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Overall Study
STARTED
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118
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Overall Study
N Patients at W24 (Primary Outcome)
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88
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Overall Study
N Patients at W36
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86
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Overall Study
N Patients at W52
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84
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Overall Study
COMPLETED
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71
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Overall Study
NOT COMPLETED
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47
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Reasons for withdrawal
| Measure |
TEOSYAL® RHA Ultra Deep / Perlane-L®
Split-face injection of TEOSYAL® RHA Ultra Deep into one NLF and Perlane-L® into the contralateral NLF. Up to 3.0 mL injected per NLF (deep-dermis to superficial subcutaneous). Touch-up treatment provided at 2 weeks (up to 3.0 mL per NLF).
TEOSYAL® RHA Ultra Deep: 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 27G½" disposable sterile needles.
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|---|---|
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Overall Study
Protocol Violation
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30
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Overall Study
Did not consent to study extension
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9
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Overall Study
Conditional re-treatment at W52
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5
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Overall Study
Lost to Follow-up
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2
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Overall Study
Withdrawal by Subject
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1
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Baseline Characteristics
TEOSYAL® RHA Ultra Deep and Perlane-L® for the Correction of Nasolabial Folds
Baseline characteristics by cohort
| Measure |
TEOSYAL® RHA Ultra Deep / Perlane-L®
n=118 Participants
Split-face injection of TEOSYAL® RHA Ultra Deep into one NLF and Perlane-L® into the contralateral NLF. Up to 3.0 mL injected per NLF (deep-dermis to superficial subcutaneous). Touch-up treatment provided at 2 weeks (up to 3.0 mL per NLF).
TEOSYAL® RHA Ultra Deep: 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 27G½" disposable sterile needles.
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|---|---|
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Age, Continuous
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57.4 years
STANDARD_DEVIATION 10.0 • n=5 Participants
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Sex: Female, Male
Female
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106 Participants
n=5 Participants
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Sex: Female, Male
Male
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12 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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30 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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88 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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1 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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1 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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19 Participants
n=5 Participants
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Race (NIH/OMB)
White
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97 Participants
n=5 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Region of Enrollment
United States
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118 Participants
n=5 Participants
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Fitzpatrick Skin Type
Types I to III
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65 Participants
n=5 Participants
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Fitzpatrick Skin Type
Types IV to VI
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53 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Baseline and 24 weeks after last treatmentWSRS (Wrinkle Severity Rating Scale) is a validated 5-point scale with 1 being 'absent' and 5 being 'extreme'. BLE =Blinded Live Evaluator
Outcome measures
| Measure |
TEOSYAL® RHA Ultra Deep
n=88 Participants
Injection of TEOSYAL® RHA Ultra Deep into one NLF
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Perlane-L®
n=88 Participants
Injection of Perlane-L® into the controlateral NLF
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|---|---|---|
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Non-inferiority of the Delta of the WSRS Score Between W24 and Baseline for TEOSYAL® RHA Ultra Deep Versus Perlane-L® for the Correction of Moderate to Severe Naso-Labial Folds Based on the Wrinkle Severity Rating Scale (WSRS) Score Assessed by the BLE.
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-1.34 units on a scale
Interval -1.46 to -1.22
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-1.16 units on a scale
Interval -1.29 to -1.03
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SECONDARY outcome
Timeframe: During 14 days after initial treatment (D0) and touch-up (2 weeks)Population: CTR are presented for the SAFT population (N=120) (see pre-assignment details) Number of patients for CTR after touch-up treatment are based on number of patients receiving Touch-up treatment (RHA-UD N=32/Perl N=47)
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 Ultra Deep
n=120 Participants
Injection of TEOSYAL® RHA Ultra Deep into one NLF
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Perlane-L®
n=120 Participants
Injection of Perlane-L® into the controlateral NLF
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Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Ultra Deep Versus Perlane-L®
Bruising (initial treatment)
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70 Participants
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72 Participants
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Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Ultra Deep Versus Perlane-L®
Bruising (Touch-up)
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17 Participants
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22 Participants
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Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Ultra Deep Versus Perlane-L®
Discolouration (initial treatment)
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50 Participants
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56 Participants
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Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Ultra Deep Versus Perlane-L®
Discolouration (Touch-up)
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9 Participants
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12 Participants
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Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Ultra Deep Versus Perlane-L®
Firmness (initial treatment)
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91 Participants
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93 Participants
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Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Ultra Deep Versus Perlane-L®
Firmness (Touch-up)
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24 Participants
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36 Participants
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Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Ultra Deep Versus Perlane-L®
Itching (initial treatment)
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30 Participants
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44 Participants
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Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Ultra Deep Versus Perlane-L®
Itching (Touch-up)
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4 Participants
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10 Participants
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Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Ultra Deep Versus Perlane-L®
Lumps/Bumps (initial treatment)
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81 Participants
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90 Participants
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Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Ultra Deep Versus Perlane-L®
Lumps/Bumps (Touch-up)
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18 Participants
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30 Participants
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Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Ultra Deep Versus Perlane-L®
Pain (initial treatment)
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66 Participants
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87 Participants
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Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Ultra Deep Versus Perlane-L®
Pain (Touch-up)
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16 Participants
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31 Participants
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Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Ultra Deep Versus Perlane-L®
Redness (initial treatment)
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84 Participants
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91 Participants
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Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Ultra Deep Versus Perlane-L®
Redness (Touch-up)
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17 Participants
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31 Participants
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Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Ultra Deep Versus Perlane-L®
Swelling (initial treatment)
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97 Participants
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104 Participants
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Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Ultra Deep Versus Perlane-L®
Swelling (Touch-up)
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27 Participants
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38 Participants
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Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Ultra Deep Versus Perlane-L®
Tenderness (initial treatment)
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90 Participants
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95 Participants
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Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Ultra Deep Versus Perlane-L®
Tenderness (Touch-up)
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21 Participants
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35 Participants
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SECONDARY outcome
Timeframe: During Injection and 5, 15, 30 minutes post-injectionPopulation: VAS are presented for the SAFT population (N=120) (see pre-assignment details) Number of patients for pain assessment after touch-up treatment are based on number of patients receiving Touch-up treatment
VAS is a 100 mm Visual Analog Scale with 0 meaning no pain and 100 meaning intolerable pain
Outcome measures
| Measure |
TEOSYAL® RHA Ultra Deep
n=120 Participants
Injection of TEOSYAL® RHA Ultra Deep into one NLF
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Perlane-L®
n=120 Participants
Injection of Perlane-L® into the controlateral NLF
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|---|---|---|
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Assessment of Injection Site Pain (Visual Analog Scale) of TEOSYAL® RHA Ultra Deep Versus Perlane-L®
Initial injection mean pain during injection
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23.43 units on a scale
Standard Deviation 21.15
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23.85 units on a scale
Standard Deviation 21.35
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Assessment of Injection Site Pain (Visual Analog Scale) of TEOSYAL® RHA Ultra Deep Versus Perlane-L®
Initial injection mean pain 5 min post-injection
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6.22 units on a scale
Standard Deviation 12.37
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5.33 units on a scale
Standard Deviation 12.76
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Assessment of Injection Site Pain (Visual Analog Scale) of TEOSYAL® RHA Ultra Deep Versus Perlane-L®
Initial injection mean pain 15 min post-injection
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2.67 units on a scale
Standard Deviation 7.38
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2.82 units on a scale
Standard Deviation 8.35
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Assessment of Injection Site Pain (Visual Analog Scale) of TEOSYAL® RHA Ultra Deep Versus Perlane-L®
Initial injection mean pain 30 min post-injection
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1.83 units on a scale
Standard Deviation 7.31
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1.65 units on a scale
Standard Deviation 7.61
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Assessment of Injection Site Pain (Visual Analog Scale) of TEOSYAL® RHA Ultra Deep Versus Perlane-L®
Touch-up injection mean pain during injection
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23.63 units on a scale
Standard Deviation 23.06
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23.34 units on a scale
Standard Deviation 19.32
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Assessment of Injection Site Pain (Visual Analog Scale) of TEOSYAL® RHA Ultra Deep Versus Perlane-L®
Touch-up injection mean pain 5 min post-injection
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8.88 units on a scale
Standard Deviation 14.46
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5.30 units on a scale
Standard Deviation 8.39
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Assessment of Injection Site Pain (Visual Analog Scale) of TEOSYAL® RHA Ultra Deep Versus Perlane-L®
Touch-up injection mean pain 15 min post-injection
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3.56 units on a scale
Standard Deviation 6.48
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2.62 units on a scale
Standard Deviation 4.88
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Assessment of Injection Site Pain (Visual Analog Scale) of TEOSYAL® RHA Ultra Deep Versus Perlane-L®
Touch-up injection mean pain 30 min post-injection
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1.81 units on a scale
Standard Deviation 4.49
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1.38 units on a scale
Standard Deviation 3.17
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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)
WSRS (Wrinkle Severity Rating Scale) is a validated 5-point scale with 1 being 'absent' and 5 being 'extreme'.
Outcome measures
| Measure |
TEOSYAL® RHA Ultra Deep
n=88 Participants
Injection of TEOSYAL® RHA Ultra Deep into one NLF
|
Perlane-L®
n=88 Participants
Injection of Perlane-L® into the controlateral NLF
|
|---|---|---|
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Delta of the WSRS Score Between W24,36,52 and 64 and Baseline for TEOSYAL® RHA Ultra Deep Versus Perlane-L® for the Correction of Moderate to Severe NLFs Based on the Wrinkle Severity Rating Scale (WSRS) Score Assessed by the Blinded Live Evaluator (BLE)
W24 Delta from baseline
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-1.34 units on a scale
Standard Deviation 0.57
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-1.16 units on a scale
Standard Deviation 0.62
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Delta of the WSRS Score Between W24,36,52 and 64 and Baseline for TEOSYAL® RHA Ultra Deep Versus Perlane-L® for the Correction of Moderate to Severe NLFs Based on the Wrinkle Severity Rating Scale (WSRS) Score Assessed by the Blinded Live Evaluator (BLE)
W36 Delta from baseline
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-1.28 units on a scale
Standard Deviation 0.63
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-1.12 units on a scale
Standard Deviation 0.60
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Delta of the WSRS Score Between W24,36,52 and 64 and Baseline for TEOSYAL® RHA Ultra Deep Versus Perlane-L® for the Correction of Moderate to Severe NLFs Based on the Wrinkle Severity Rating Scale (WSRS) Score Assessed by the Blinded Live Evaluator (BLE)
W52 Delta from baseline
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-1.23 units on a scale
Standard Deviation 0.74
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-1.05 units on a scale
Standard Deviation 0.67
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Delta of the WSRS Score Between W24,36,52 and 64 and Baseline for TEOSYAL® RHA Ultra Deep Versus Perlane-L® for the Correction of Moderate to Severe NLFs Based on the Wrinkle Severity Rating Scale (WSRS) Score Assessed by the Blinded Live Evaluator (BLE)
W64 Delta from baseline
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-1.26 units on a scale
Standard Deviation 0.71
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-1.11 units on a scale
Standard Deviation 0.71
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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)
WSRS (Wrinkle Severity Rating Scale) is a validated 5-point scale with 1 being 'absent' and 5 being 'extreme'.
Outcome measures
| Measure |
TEOSYAL® RHA Ultra Deep
n=88 Participants
Injection of TEOSYAL® RHA Ultra Deep into one NLF
|
Perlane-L®
n=88 Participants
Injection of Perlane-L® into the controlateral NLF
|
|---|---|---|
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Delta of the WSRS Score Between W2,4,12,24,36,52,64 and Baseline for TEOSYAL® RHA Ultra Deep Versus Perlane-L® for the Correction of Moderate to Severe NLFs Based on the Wrinkle Severity Rating Scale (WSRS) Score Assessed by the Treating Investigator (TI)
W2 Delta from baseline
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-1.77 units on a scale
Standard Deviation 0.60
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-1.51 units on a scale
Standard Deviation 0.68
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|
Delta of the WSRS Score Between W2,4,12,24,36,52,64 and Baseline for TEOSYAL® RHA Ultra Deep Versus Perlane-L® for the Correction of Moderate to Severe NLFs Based on the Wrinkle Severity Rating Scale (WSRS) Score Assessed by the Treating Investigator (TI)
W4 Delta from baseline
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-1.85 units on a scale
Standard Deviation 0.58
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-1.60 units on a scale
Standard Deviation 0.63
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|
Delta of the WSRS Score Between W2,4,12,24,36,52,64 and Baseline for TEOSYAL® RHA Ultra Deep Versus Perlane-L® for the Correction of Moderate to Severe NLFs Based on the Wrinkle Severity Rating Scale (WSRS) Score Assessed by the Treating Investigator (TI)
W12 Delta from baseline
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-1.70 units on a scale
Standard Deviation 0.78
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-1.34 units on a scale
Standard Deviation 0.74
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|
Delta of the WSRS Score Between W2,4,12,24,36,52,64 and Baseline for TEOSYAL® RHA Ultra Deep Versus Perlane-L® for the Correction of Moderate to Severe NLFs Based on the Wrinkle Severity Rating Scale (WSRS) Score Assessed by the Treating Investigator (TI)
W24 Delta from baseline
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-1.45 units on a scale
Standard Deviation 0.76
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-1.05 units on a scale
Standard Deviation 0.76
|
|
Delta of the WSRS Score Between W2,4,12,24,36,52,64 and Baseline for TEOSYAL® RHA Ultra Deep Versus Perlane-L® for the Correction of Moderate to Severe NLFs Based on the Wrinkle Severity Rating Scale (WSRS) Score Assessed by the Treating Investigator (TI)
W36 Delta from baseline
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-1.50 units on a scale
Standard Deviation 0.78
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-1.16 units on a scale
Standard Deviation 0.73
|
|
Delta of the WSRS Score Between W2,4,12,24,36,52,64 and Baseline for TEOSYAL® RHA Ultra Deep Versus Perlane-L® for the Correction of Moderate to Severe NLFs Based on the Wrinkle Severity Rating Scale (WSRS) Score Assessed by the Treating Investigator (TI)
W52 Delta from baseline
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-1.38 units on a scale
Standard Deviation 0.71
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-0.99 units on a scale
Standard Deviation 0.67
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|
Delta of the WSRS Score Between W2,4,12,24,36,52,64 and Baseline for TEOSYAL® RHA Ultra Deep Versus Perlane-L® for the Correction of Moderate to Severe NLFs Based on the Wrinkle Severity Rating Scale (WSRS) Score Assessed by the Treating Investigator (TI)
W64 Delta from baseline
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-1.32 units on a scale
Standard Deviation 0.82
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-1.03 units on a scale
Standard Deviation 0.77
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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 Ultra Deep
n=88 Participants
Injection of TEOSYAL® RHA Ultra Deep into one NLF
|
Perlane-L®
n=88 Participants
Injection of Perlane-L® into the controlateral NLF
|
|---|---|---|
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Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the Wrinkle Severity Rating Scale (WSRS) Compared to Baseline Assessed by the BLE
W24
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97.7 percentage of responders
Interval 92.0 to 99.7
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88.6 percentage of responders
Interval 80.1 to 94.4
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Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the Wrinkle Severity Rating Scale (WSRS) Compared to Baseline Assessed by the BLE
W36
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90.7 percentage of responders
Interval 82.5 to 95.9
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87.2 percentage of responders
Interval 78.3 to 93.4
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Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the Wrinkle Severity Rating Scale (WSRS) Compared to Baseline Assessed by the BLE
W52
|
87.0 percentage of responders
Interval 77.4 to 94.0
|
83.1 percentage of responders
Interval 72.9 to 90.7
|
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Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the Wrinkle Severity Rating Scale (WSRS) Compared to Baseline Assessed by the BLE
W64
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89.2 percentage of responders
Interval 79.1 to 95.6
|
84.6 percentage of responders
Interval 73.5 to 92.4
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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 Ultra Deep
n=88 Participants
Injection of TEOSYAL® RHA Ultra Deep into one NLF
|
Perlane-L®
n=88 Participants
Injection of Perlane-L® into the controlateral NLF
|
|---|---|---|
|
Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the Wrinkle Severity Rating Scale (WSRS) Compared to Baseline Assessed by the TI
W64
|
83.1 percentage of responders
Interval 72.3 to 91.0
|
76.1 percentage of responders
Interval 64.5 to 85.4
|
|
Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the Wrinkle Severity Rating Scale (WSRS) Compared to Baseline Assessed by the TI
W2
|
97.7 percentage of responders
Interval 92.0 to 99.7
|
93.2 percentage of responders
Interval 85.8 to 97.5
|
|
Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the Wrinkle Severity Rating Scale (WSRS) Compared to Baseline Assessed by the TI
W4
|
100.0 percentage of responders
Interval 95.9 to 100.0
|
97.7 percentage of responders
Interval 92.0 to 99.7
|
|
Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the Wrinkle Severity Rating Scale (WSRS) Compared to Baseline Assessed by the TI
W12
|
95.5 percentage of responders
Interval 88.8 to 98.8
|
88.6 percentage of responders
Interval 80.1 to 94.4
|
|
Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the Wrinkle Severity Rating Scale (WSRS) Compared to Baseline Assessed by the TI
W24
|
90.9 percentage of responders
Interval 82.9 to 96.0
|
78.4 percentage of responders
Interval 68.4 to 86.5
|
|
Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the Wrinkle Severity Rating Scale (WSRS) Compared to Baseline Assessed by the TI
W36
|
90.7 percentage of responders
Interval 82.5 to 95.9
|
83.7 percentage of responders
Interval 74.2 to 90.8
|
|
Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the Wrinkle Severity Rating Scale (WSRS) Compared to Baseline Assessed by the TI
W52
|
92.9 percentage of responders
Interval 85.1 to 97.3
|
77.4 percentage of responders
Interval 67.0 to 85.8
|
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". GAI was assessed using the baseline photograph. Each side of the face was assessed independently.
Outcome measures
| Measure |
TEOSYAL® RHA Ultra Deep
n=88 Participants
Injection of TEOSYAL® RHA Ultra Deep into one NLF
|
Perlane-L®
n=88 Participants
Injection of Perlane-L® into the controlateral NLF
|
|---|---|---|
|
Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) by the Blinded Live Evaluator (BLE)
W24
|
84 Participants
|
80 Participants
|
|
Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) by the Blinded Live Evaluator (BLE)
W36
|
80 Participants
|
77 Participants
|
|
Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) by the Blinded Live Evaluator (BLE)
W52
|
65 Participants
|
62 Participants
|
|
Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) by the Blinded Live Evaluator (BLE)
W64
|
52 Participants
|
47 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". 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 Ultra Deep
n=88 Participants
Injection of TEOSYAL® RHA Ultra Deep into one NLF
|
Perlane-L®
n=88 Participants
Injection of Perlane-L® into the controlateral NLF
|
|---|---|---|
|
Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either "Much Improved" or "Improved") on GAI Scale.
W24
|
82 Participants
|
78 Participants
|
|
Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either "Much Improved" or "Improved") on GAI Scale.
W4
|
87 Participants
|
88 Participants
|
|
Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either "Much Improved" or "Improved") on GAI Scale.
W12
|
87 Participants
|
85 Participants
|
|
Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either "Much Improved" or "Improved") on GAI Scale.
W36
|
81 Participants
|
78 Participants
|
|
Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either "Much Improved" or "Improved") on GAI Scale.
W52
|
77 Participants
|
73 Participants
|
|
Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either "Much Improved" or "Improved") on GAI Scale.
W64
|
64 Participants
|
58 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 Ultra Deep
n=88 Participants
Injection of TEOSYAL® RHA Ultra Deep into one NLF
|
Perlane-L®
n=88 Participants
Injection of Perlane-L® into the controlateral NLF
|
|---|---|---|
|
Subject's Perception of Treatment Effectiveness as Per the FACE-Q (NLF Domain) Questionnaire
pre-treatment
|
24.7 units on a scale
Standard Deviation 19.2
|
25.7 units on a scale
Standard Deviation 19.6
|
|
Subject's Perception of Treatment Effectiveness as Per the FACE-Q (NLF Domain) Questionnaire
W2
|
77.1 units on a scale
Standard Deviation 23.3
|
74.0 units on a scale
Standard Deviation 23.9
|
|
Subject's Perception of Treatment Effectiveness as Per the FACE-Q (NLF Domain) Questionnaire
W4
|
84.3 units on a scale
Standard Deviation 21.0
|
81.2 units on a scale
Standard Deviation 21.0
|
|
Subject's Perception of Treatment Effectiveness as Per the FACE-Q (NLF Domain) Questionnaire
W12
|
80.1 units on a scale
Standard Deviation 22.3
|
74.4 units on a scale
Standard Deviation 25.0
|
|
Subject's Perception of Treatment Effectiveness as Per the FACE-Q (NLF Domain) Questionnaire
W24
|
70.9 units on a scale
Standard Deviation 22.3
|
66.1 units on a scale
Standard Deviation 24.2
|
|
Subject's Perception of Treatment Effectiveness as Per the FACE-Q (NLF Domain) Questionnaire
W36
|
68.9 units on a scale
Standard Deviation 25.0
|
61.5 units on a scale
Standard Deviation 25.5
|
|
Subject's Perception of Treatment Effectiveness as Per the FACE-Q (NLF Domain) Questionnaire
W52
|
72.0 units on a scale
Standard Deviation 25.6
|
65.9 units on a scale
Standard Deviation 27.2
|
|
Subject's Perception of Treatment Effectiveness as Per the FACE-Q (NLF Domain) Questionnaire
W64
|
69.7 units on a scale
Standard Deviation 24.0
|
64.2 units on a scale
Standard Deviation 27.5
|
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 Ultra Deep
n=88 Participants
Injection of TEOSYAL® RHA Ultra Deep into one NLF
|
Perlane-L®
n=88 Participants
Injection of Perlane-L® into the controlateral NLF
|
|---|---|---|
|
Subject's Satisfaction Score
W2
|
1.49 units on a scale
Standard Deviation 0.61
|
1.63 units on a scale
Standard Deviation 0.88
|
|
Subject's Satisfaction Score
W4
|
1.28 units on a scale
Standard Deviation 0.57
|
1.31 units on a scale
Standard Deviation 0.58
|
|
Subject's Satisfaction Score
W12
|
1.41 units on a scale
Standard Deviation 0.62
|
1.62 units on a scale
Standard Deviation 0.83
|
|
Subject's Satisfaction Score
W24
|
1.53 units on a scale
Standard Deviation 0.66
|
1.79 units on a scale
Standard Deviation 0.84
|
|
Subject's Satisfaction Score
W36
|
1.64 units on a scale
Standard Deviation 0.75
|
1.95 units on a scale
Standard Deviation 0.96
|
|
Subject's Satisfaction Score
W52
|
1.54 units on a scale
Standard Deviation 0.70
|
1.77 units on a scale
Standard Deviation 0.87
|
|
Subject's Satisfaction Score
W64
|
1.40 units on a scale
Standard Deviation 0.60
|
1.67 units on a scale
Standard Deviation 0.90
|
SECONDARY outcome
Timeframe: Week 2Outcome measures
| Measure |
TEOSYAL® RHA Ultra Deep
n=88 Participants
Injection of TEOSYAL® RHA Ultra Deep into one NLF
|
Perlane-L®
n=88 Participants
Injection of Perlane-L® into the controlateral NLF
|
|---|---|---|
|
Volume to Obtain Optimal Cosmetic Result (Initial Treatment + Touch-up)
|
1.79 mL
Standard Deviation 0.87
|
1.75 mL
Standard Deviation 0.90
|
SECONDARY outcome
Timeframe: Week 2Outcome measures
| Measure |
TEOSYAL® RHA Ultra Deep
n=88 Participants
Injection of TEOSYAL® RHA Ultra Deep into one NLF
|
Perlane-L®
n=88 Participants
Injection of Perlane-L® into the controlateral NLF
|
|---|---|---|
|
Number of Subjects Receiving Touch-up Treatment
|
28 Participants
|
38 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 Ultra Deep
n=88 Participants
Injection of TEOSYAL® RHA Ultra Deep into one NLF
|
Perlane-L®
n=88 Participants
Injection of Perlane-L® into the controlateral NLF
|
|---|---|---|
|
Number of Subjects Receiving Re-treatment
W24
|
6 Participants
|
6 Participants
|
|
Number of Subjects Receiving Re-treatment
W36
|
3 Participants
|
6 Participants
|
|
Number of Subjects Receiving Re-treatment
W52
|
12 Participants
|
13 Participants
|
|
Number of Subjects Receiving Re-treatment
W64
|
49 Participants
|
50 Participants
|
Adverse Events
TEOSYAL® RHA Ultra Deep
Serious events: 3 serious events
Other events: 75 other events
Deaths: 0 deaths
Perlane-L®
Serious events: 3 serious events
Other events: 74 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TEOSYAL® RHA Ultra Deep
n=120 participants at risk
Injection of TEOSYAL® RHA Ultra Deep into one NLF
|
Perlane-L®
n=120 participants at risk
Injection of Perlane-L® into the controlateral NLF
|
|---|---|---|
|
General disorders
Arthralgia
|
0.83%
1/120 • 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. Adverse Events are presented for the SAFT population (N=120) (see pre-assignment details)
|
0.83%
1/120 • 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. Adverse Events are presented for the SAFT population (N=120) (see pre-assignment details)
|
|
General disorders
Diverticulitis
|
0.83%
1/120 • 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. Adverse Events are presented for the SAFT population (N=120) (see pre-assignment details)
|
0.83%
1/120 • 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. Adverse Events are presented for the SAFT population (N=120) (see pre-assignment details)
|
|
Infections and infestations
Lung Infection
|
0.83%
1/120 • 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. Adverse Events are presented for the SAFT population (N=120) (see pre-assignment details)
|
0.83%
1/120 • 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. Adverse Events are presented for the SAFT population (N=120) (see pre-assignment details)
|
Other adverse events
| Measure |
TEOSYAL® RHA Ultra Deep
n=120 participants at risk
Injection of TEOSYAL® RHA Ultra Deep into one NLF
|
Perlane-L®
n=120 participants at risk
Injection of Perlane-L® into the controlateral NLF
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
4.2%
5/120 • 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. Adverse Events are presented for the SAFT population (N=120) (see pre-assignment details)
|
2.5%
3/120 • 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. Adverse Events are presented for the SAFT population (N=120) (see pre-assignment details)
|
|
General disorders
Injection Lumps/Bumps
|
37.5%
45/120 • Number of events 52 • 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. Adverse Events are presented for the SAFT population (N=120) (see pre-assignment details)
|
28.3%
34/120 • Number of events 43 • 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. Adverse Events are presented for the SAFT population (N=120) (see pre-assignment details)
|
|
General disorders
Injection site firmness
|
37.5%
45/120 • Number of events 52 • 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. Adverse Events are presented for the SAFT population (N=120) (see pre-assignment details)
|
28.3%
34/120 • Number of events 39 • 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. Adverse Events are presented for the SAFT population (N=120) (see pre-assignment details)
|
|
General disorders
Injection site swelling
|
20.0%
24/120 • Number of events 28 • 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. Adverse Events are presented for the SAFT population (N=120) (see pre-assignment details)
|
14.2%
17/120 • Number of events 21 • 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. Adverse Events are presented for the SAFT population (N=120) (see pre-assignment details)
|
|
General disorders
Tenderness
|
15.8%
19/120 • 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. Adverse Events are presented for the SAFT population (N=120) (see pre-assignment details)
|
10.0%
12/120 • Number of events 14 • 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. Adverse Events are presented for the SAFT population (N=120) (see pre-assignment details)
|
|
General disorders
Injection site discolouration
|
10.8%
13/120 • Number of events 13 • 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. Adverse Events are presented for the SAFT population (N=120) (see pre-assignment details)
|
5.8%
7/120 • 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. Adverse Events are presented for the SAFT population (N=120) (see pre-assignment details)
|
|
General disorders
Injection site erythema
|
6.7%
8/120 • 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. Adverse Events are presented for the SAFT population (N=120) (see pre-assignment details)
|
6.7%
8/120 • 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. Adverse Events are presented for the SAFT population (N=120) (see pre-assignment details)
|
|
General disorders
Injection site haematoma
|
6.7%
8/120 • 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. Adverse Events are presented for the SAFT population (N=120) (see pre-assignment details)
|
3.3%
4/120 • 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. Adverse Events are presented for the SAFT population (N=120) (see pre-assignment details)
|
|
General disorders
Injection site pain
|
5.0%
6/120 • 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. Adverse Events are presented for the SAFT population (N=120) (see pre-assignment details)
|
4.2%
5/120 • 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. Adverse Events are presented for the SAFT population (N=120) (see pre-assignment details)
|
|
Nervous system disorders
Headache
|
5.0%
6/120 • 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. Adverse Events are presented for the SAFT population (N=120) (see pre-assignment details)
|
5.0%
6/120 • Number of events 10 • 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. Adverse Events are presented for the SAFT population (N=120) (see pre-assignment details)
|
|
Skin and subcutaneous tissue disorders
Acne
|
4.2%
5/120 • 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. Adverse Events are presented for the SAFT population (N=120) (see pre-assignment details)
|
5.0%
6/120 • 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. Adverse Events are presented for the SAFT population (N=120) (see pre-assignment details)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60