Nasolabial Folds, Wrinkles
Conditions
Keywords
Nasolabial folds, Dermal filler, Hyaluronic acid (HA), Wrinkles
Brief summary
The purpose of this study is 1) to compare the effectiveness and safety of TEOSYAL® RHA Global Action versus Juvéderm® Ultra XC, and 2) to compare the effectiveness and safety of TEOSYAL® RHA Deep Lines versus Juvéderm® Ultra XC, in the treatment of moderate to severe nasolabial folds.
Interventions
DEVICETEOSYAL® 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.
DEVICETEOSYAL® 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.
Sponsors
ethica Clinical Research Inc.
Teoxane SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Outpatient, male or female of any race, 22 years of age or older; female subjects of childbearing potential must have a negative urine pregnancy test and practice a reliable method of contraception * NLFs classified as WSRS grade 3 or 4 (same score for each side) * Willing to abstain from facial aesthetic procedures/therapies that could interfere with study evaluations * Able to follow study instructions and likely to complete all required visits; * Signed informed consent and HIPAA (Health Insurance Portability and Accountability Act) form
Exclusion criteria
* Female subjects that are pregnant or breast-feeding, or of childbearing potential and not practicing reliable birth control * Known hypersensitivity/allergy to any component of the study devices * Known sensitivity to local anesthetics of the amide type, history of multiple severe allergies, history of anaphylactic shock * Known susceptibility to keloid formation, hypertrophic scarring or clinically significant skin pigmentation disorders * Clinically significant active skin disease within 6 months * History of active chronic debilitating systemic disease * History of connective tissue disease * History of malignancy (excl. non-melanoma skin cancer) within past 5 years * History of bleeding disorders * Need for clinically significant and continuous medical treatment within 2 weeks prior to first visit * Received/used a prohibited treatment/procedure within certain time periods (e.g., bioresorbable fillers, NSAIDS, acetylsalicylic acid, high dose vitamin E, corticosteroids, interferon, anti-coagulation therapies, laser/light therapies, botulinum toxin injections (frontalis and glabella complex treatment permitted), prescription strength topical retinoids, facial peels, excisional facial surgery, clinically significant oral or maxillofacial surgery) * Clinically significant alcohol or drug abuse, or history of poor cooperation, non-compliance with medical treatment, or unreliability * Exhibit a physical attribute(s) that may prevent assessment or treatment of NLFs such as excessive facial hair, traumatic or surgical facial scars, and/or excessive hyperpigmentation in the treatment areas * A condition or situation that may put the subject at significant risk, confound the study results, or significantly interfere with the subject participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). | Baseline and 24 weeks after last treatment | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). | During Injection and 5, 15, 30 minutes post-injection | VAS is a 100 mm Visual Analog Scale with 0 meaning no pain and 100 meaning intolerable pain |
| 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 | Baseline and Weeks 24, 36, 52, 64 | 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 |
| 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 | Baseline and Weeks 2, 4, 12, 24, 36, 52, 64 | 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 |
| Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the WSRS Compared to Baseline Assessed by the BLE | Baseline and Weeks 24, 36, 52, 64 | A responder correspond to a subject with an intra-individual improvement of at least one grade in the WSRS compared to baseline |
| Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the WSRS Compared to Baseline Assessed by the TI | Baseline and Weeks 2, 4, 12, 24, 36, 52, 64 | A responder correspond to a subject with an intra-individual improvement of at least one grade in the WSRS compared to baseline |
| Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE). | Weeks 24, 36, 52, 64 | 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. |
| 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). | During 14 days after initial treatment (D0) and touch-up (2 weeks) | 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) |
| Subject's Perception of Treatment Effectiveness as Per the FACE-Q (NLF Domain) Questionnaire | Immediately post-injection, and weeks 2, 4, 12, 24, 36, 52, 64 | 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. |
| Subject's Satisfaction Score | Weeks 2, 4, 12, 24, 36, 52, 64 | Subjective 5-point scale with 1 being 'very satisfied' and 5 being 'very dissatisfied' |
| Volume to Obtain Optimal Cosmetic Result (Initial Treatment + Touch-up) | Week 2 | — |
| Number of Subjects Receiving Touch-up Treatment. | Week 2 | — |
| Number of Subjects Receiving Re-treatment | Weeks 24, 36, 52, 64 | — |
| Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either Much Improved or Improved) on GAI Scale. | Weeks 4, 12, 24, 36, 52, 64 | 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. |
Countries
United States
Participant flow
Recruitment details
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)
Pre-assignment details
One subject randomized to the RHA GA/J withdrew consent prior to receiving initial treatment reducing the population for this cohort to n=73.
Participants by arm
| Arm | Count |
|---|---|
| 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). | 73 |
| 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). | 74 |
| Total | 147 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Conditional re-treatment at W52 | 2 | 1 |
| Overall Study | Did not consent to study extension | 13 | 9 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Protocol Violation | 7 | 14 |
| Overall Study | Withdrawal by Subject | 4 | 2 |
Baseline characteristics
| Characteristic | TEOSYAL RHA Deep Lines/Juvederm Ultra XC | Total | TEOSYAL RHA Global Action/Juvederm Ultra XC |
|---|---|---|---|
| Age, Continuous | 55.7 years STANDARD_DEVIATION 9.4 | 55.6 years STANDARD_DEVIATION 9.9 | 55.5 years STANDARD_DEVIATION 10.9 |
| Fitzpatrick Skin Type Types I to III | 44 Participants | 89 Participants | 45 Participants |
| Fitzpatrick Skin Type Types IV to VI | 30 Participants | 58 Participants | 28 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 16 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 8 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 62 Participants | 121 Participants | 59 Participants |
| Region of Enrollment United States | 74 Participants | 147 Participants | 73 Participants |
| Sex: Female, Male Female | 68 Participants | 130 Participants | 62 Participants |
| Sex: Female, Male Male | 6 Participants | 17 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 39 / 72 | 36 / 72 | 30 / 75 | 31 / 75 |
| serious Total, serious adverse events | 2 / 75 | 2 / 75 | 0 / 75 | 0 / 75 |
Outcome results
Primary
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).
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
Time frame: Baseline and 24 weeks after last treatment
| Arm | Measure | Value (MEAN) |
|---|---|---|
| TEOSYAL® RHA Global Action | 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 |
| Juvéderm® Ultra XC (RHA GA) | 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). | -1.13 units on a scale |
| 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). | -1.32 units on a scale |
| Juvéderm® Ultra XC (RHA DL) | 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). | -1.23 units on a scale |
Comparison: Efficacy of TEOSYAL® RHA Global Action versus control is analyzed in a non-inferiority statistical model using the 5-grade Wrinkle Severity Rating Scale (WSRS) as rated by the Blinded Live Evaluator at 24 weeks after baseline.~The primary endpoint is the aesthetic improvement from pre-injection of the NLF at the side of the face treated with TEOSYAL® RHA Ultra Deep compared to the one at the side of the face treated with the control device, as assessed by the BLE at 24 weeks after baseline.97.5% CI: [-0.17, 0.11]
Comparison: Efficacy of TEOSYAL® RHA Deep Lines versus control is analyzed in a non-inferiority statistical model using the 5-grade Wrinkle Severity Rating Scale (WSRS) as rated by the Blinded Live Evaluator at 24 weeks after baseline.~The primary endpoint is the aesthetic improvement from pre-injection of the NLF at the side of the face treated with TEOSYAL® RHA Deep Lines compared to the one at the side of the face treated with the control device, as assessed by the BLE at 24 weeks after baseline97.5% CI: [-0.25, 0.06]
Secondary
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).
VAS is a 100 mm Visual Analog Scale with 0 meaning no pain and 100 meaning intolerable pain
Time frame: During Injection and 5, 15, 30 minutes post-injection
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 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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TEOSYAL® RHA Global Action | 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 |
| TEOSYAL® RHA Global Action | 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 |
| TEOSYAL® RHA Global Action | 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 |
| TEOSYAL® RHA Global Action | 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 |
| TEOSYAL® RHA Global Action | 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 |
| TEOSYAL® RHA Global Action | 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 |
| TEOSYAL® RHA Global Action | 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 |
| TEOSYAL® RHA Global Action | 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 |
| Juvéderm® Ultra XC (RHA GA) | 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 | 2.8 VAS score | Standard Deviation 7.3 |
| Juvéderm® Ultra XC (RHA GA) | 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 | 11.8 VAS score | Standard Deviation 14.6 |
| Juvéderm® Ultra XC (RHA GA) | 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 | 3.9 VAS score | Standard Deviation 9.5 |
| Juvéderm® Ultra XC (RHA GA) | 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 | 1.0 VAS score | Standard Deviation 5 |
| Juvéderm® Ultra XC (RHA GA) | 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 | 1.3 VAS score | Standard Deviation 5.8 |
| Juvéderm® Ultra XC (RHA GA) | 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 | 0.7 VAS score | Standard Deviation 1.9 |
| Juvéderm® Ultra XC (RHA GA) | 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 | 1.4 VAS score | Standard Deviation 3.9 |
| Juvéderm® Ultra XC (RHA GA) | 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 | 13.9 VAS score | Standard Deviation 17.4 |
| 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 15 min post-injection | 2.2 VAS score | Standard Deviation 5.2 |
| 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). | Initial injection mean pain 15 min post-injection | 2.0 VAS score | Standard Deviation 5.5 |
| 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). | Initial injection mean pain 30 min post-injection | 1.0 VAS score | Standard Deviation 3 |
| 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 during injection | 15.9 VAS score | Standard Deviation 17.4 |
| 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 5 min post-injection | 4.6 VAS score | Standard Deviation 9.7 |
| 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 | 1.5 VAS score | Standard Deviation 4.6 |
| 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). | Initial injection mean pain during injection | 16.7 VAS score | Standard Deviation 17.8 |
| 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). | Initial injection mean pain 5 min post-injection | 3.7 VAS score | Standard Deviation 7.7 |
| Juvéderm® Ultra XC (RHA DL) | 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 | 1.4 VAS score | Standard Deviation 3.2 |
| Juvéderm® Ultra XC (RHA DL) | 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 0.9 |
| Juvéderm® Ultra XC (RHA DL) | 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 | 2.9 VAS score | Standard Deviation 5.1 |
| Juvéderm® Ultra XC (RHA DL) | 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 | 14.6 VAS score | Standard Deviation 17.7 |
| Juvéderm® Ultra XC (RHA DL) | 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 | 14.5 VAS score | Standard Deviation 18.4 |
| Juvéderm® Ultra XC (RHA DL) | 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 3.9 |
| Juvéderm® Ultra XC (RHA DL) | 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 | 1.9 VAS score | Standard Deviation 4.6 |
| Juvéderm® Ultra XC (RHA DL) | 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 | 3.5 VAS score | Standard Deviation 7.3 |
Secondary
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
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
Time frame: Baseline and Weeks 2, 4, 12, 24, 36, 52, 64
Population: Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available (See participant flow)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TEOSYAL® RHA Global Action | 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 |
| TEOSYAL® RHA Global Action | 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 |
| TEOSYAL® RHA Global Action | 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 |
| TEOSYAL® RHA Global Action | 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 |
| TEOSYAL® RHA Global Action | 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 |
| TEOSYAL® RHA Global Action | 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 |
| TEOSYAL® RHA Global Action | 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 |
| Juvéderm® Ultra XC (RHA GA) | 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 | -1.16 WSRS Delta from V1 | Standard Deviation 0.63 |
| Juvéderm® Ultra XC (RHA GA) | 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 | -1.25 WSRS Delta from V1 | Standard Deviation 0.7 |
| Juvéderm® Ultra XC (RHA GA) | 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 | -1.32 WSRS Delta from V1 | Standard Deviation 0.77 |
| Juvéderm® Ultra XC (RHA GA) | 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 | -1.17 WSRS Delta from V1 | Standard Deviation 0.72 |
| Juvéderm® Ultra XC (RHA GA) | 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 | -0.98 WSRS Delta from V1 | Standard Deviation 0.61 |
| Juvéderm® Ultra XC (RHA GA) | 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 | -1.69 WSRS Delta from V1 | Standard Deviation 0.64 |
| Juvéderm® Ultra XC (RHA GA) | 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 | -1.34 WSRS Delta from V1 | Standard Deviation 0.73 |
| 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 | W24 Delta from V1 | -1.55 WSRS Delta from V1 | Standard Deviation 0.59 |
| 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 | -1.45 WSRS Delta from V1 | Standard Deviation 0.64 |
| 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 | W4 Delta from V1 | -1.84 WSRS Delta from V1 | Standard Deviation 0.45 |
| 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 | W12 Delta from V1 | -1.65 WSRS Delta from V1 | Standard Deviation 0.55 |
| 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 | W36 Delta from V1 | -1.08 WSRS Delta from V1 | Standard Deviation 0.65 |
| 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 | W52 Delta from V1 | -1.07 WSRS Delta from V1 | Standard Deviation 0.68 |
| 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 | W64 Delta from V1 | -0.98 WSRS Delta from V1 | Standard Deviation 0.57 |
| Juvéderm® Ultra XC (RHA DL) | 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 | -1.58 WSRS Delta from V1 | Standard Deviation 0.56 |
| Juvéderm® Ultra XC (RHA DL) | 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 | -0.89 WSRS Delta from V1 | Standard Deviation 0.63 |
| Juvéderm® Ultra XC (RHA DL) | 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 | -0.93 WSRS Delta from V1 | Standard Deviation 0.57 |
| Juvéderm® Ultra XC (RHA DL) | 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 | -1.77 WSRS Delta from V1 | Standard Deviation 0.5 |
| Juvéderm® Ultra XC (RHA DL) | 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 | -1.31 WSRS Delta from V1 | Standard Deviation 0.59 |
| Juvéderm® Ultra XC (RHA DL) | 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 | -1.03 WSRS Delta from V1 | Standard Deviation 0.67 |
| Juvéderm® Ultra XC (RHA DL) | 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 | -1.39 WSRS Delta from V1 | Standard Deviation 0.55 |
Secondary
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
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
Time frame: Baseline and Weeks 24, 36, 52, 64
Population: Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available (See participant flow)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TEOSYAL® RHA Global Action | 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 |
| TEOSYAL® RHA Global Action | 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 |
| TEOSYAL® RHA Global Action | 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 0.6 |
| TEOSYAL® RHA Global Action | 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 |
| Juvéderm® Ultra XC (RHA GA) | 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 0.6 |
| Juvéderm® Ultra XC (RHA GA) | 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 0.65 |
| Juvéderm® Ultra XC (RHA GA) | 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 | -1.00 WSRS Delta from V1 | Standard Deviation 0.63 |
| Juvéderm® Ultra XC (RHA GA) | 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 | -1.13 WSRS Delta from V1 | Standard Deviation 0.72 |
| 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 | W52 Delta from V1 | -0.91 WSRS Delta from V1 | Standard Deviation 0.77 |
| 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 | W36 Delta from V1 | -1.03 WSRS Delta from V1 | Standard Deviation 0.7 |
| 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 | W64 Delta fom V1 | -0.91 WSRS Delta from V1 | Standard Deviation 0.72 |
| 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 | -1.32 WSRS Delta from V1 | Standard Deviation 0.7 |
| Juvéderm® Ultra XC (RHA DL) | 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 | -0.83 WSRS Delta from V1 | Standard Deviation 0.67 |
| Juvéderm® Ultra XC (RHA DL) | 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 | -0.98 WSRS Delta from V1 | Standard Deviation 0.69 |
| Juvéderm® Ultra XC (RHA DL) | 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 | -1.23 WSRS Delta from V1 | Standard Deviation 0.71 |
| Juvéderm® Ultra XC (RHA DL) | 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 | -0.82 WSRS Delta from V1 | Standard Deviation 0.74 |
Secondary
Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either Much Improved or Improved) on GAI Scale.
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.
Time frame: Weeks 4, 12, 24, 36, 52, 64
Population: Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available (See participant flow)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TEOSYAL® RHA Global Action | Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either Much Improved or Improved) on GAI Scale. | W52 | 55 Participants |
| TEOSYAL® RHA Global Action | Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either Much Improved or Improved) on GAI Scale. | W64 | 44 Participants |
| TEOSYAL® RHA Global Action | Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either Much Improved or Improved) on GAI Scale. | W12 | 60 Participants |
| TEOSYAL® RHA Global Action | Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either Much Improved or Improved) on GAI Scale. | W24 | 59 Participants |
| TEOSYAL® RHA Global Action | Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either Much Improved or Improved) on GAI Scale. | W36 | 59 Participants |
| TEOSYAL® RHA Global Action | Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either Much Improved or Improved) on GAI Scale. | W4 | 64 Participants |
| Juvéderm® Ultra XC (RHA GA) | Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either Much Improved or Improved) on GAI Scale. | W12 | 59 Participants |
| Juvéderm® Ultra XC (RHA GA) | Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either Much Improved or Improved) on GAI Scale. | W4 | 63 Participants |
| Juvéderm® Ultra XC (RHA GA) | Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either Much Improved or Improved) on GAI Scale. | W24 | 59 Participants |
| Juvéderm® Ultra XC (RHA GA) | Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either Much Improved or Improved) on GAI Scale. | W52 | 53 Participants |
| Juvéderm® Ultra XC (RHA GA) | Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either Much Improved or Improved) on GAI Scale. | W64 | 45 Participants |
| Juvéderm® Ultra XC (RHA GA) | Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either Much Improved or Improved) on GAI Scale. | W36 | 58 Participants |
| TEOSYAL® RHA Deep Lines | Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either Much Improved or Improved) on GAI Scale. | W4 | 59 Participants |
| TEOSYAL® RHA Deep Lines | Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either Much Improved or Improved) on GAI Scale. | W12 | 59 Participants |
| TEOSYAL® RHA Deep Lines | Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either Much Improved or Improved) on GAI Scale. | W52 | 50 Participants |
| TEOSYAL® RHA Deep Lines | Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either Much Improved or Improved) on GAI Scale. | W36 | 54 Participants |
| TEOSYAL® RHA Deep Lines | Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either Much Improved or Improved) on GAI Scale. | W64 | 43 Participants |
| TEOSYAL® RHA Deep Lines | Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either Much Improved or Improved) on GAI Scale. | W24 | 55 Participants |
| Juvéderm® Ultra XC (RHA DL) | Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either Much Improved or Improved) on GAI Scale. | W64 | 41 Participants |
| Juvéderm® Ultra XC (RHA DL) | Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either Much Improved or Improved) on GAI Scale. | W4 | 59 Participants |
| Juvéderm® Ultra XC (RHA DL) | Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either Much Improved or Improved) on GAI Scale. | W12 | 60 Participants |
| Juvéderm® Ultra XC (RHA DL) | Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either Much Improved or Improved) on GAI Scale. | W24 | 55 Participants |
| Juvéderm® Ultra XC (RHA DL) | Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either Much Improved or Improved) on GAI Scale. | W36 | 53 Participants |
| Juvéderm® Ultra XC (RHA DL) | Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either Much Improved or Improved) on GAI Scale. | W52 | 49 Participants |
Secondary
Number of Subjects Receiving Re-treatment
Time frame: Weeks 24, 36, 52, 64
Population: Numbers of patients analyzed correspond to patients that have completed the visits (See participant flow)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TEOSYAL® RHA Global Action | Number of Subjects Receiving Re-treatment | W36 | 3 Participants |
| TEOSYAL® RHA Global Action | Number of Subjects Receiving Re-treatment | W52 | 9 Participants |
| TEOSYAL® RHA Global Action | Number of Subjects Receiving Re-treatment | W64 | 42 Participants |
| TEOSYAL® RHA Global Action | Number of Subjects Receiving Re-treatment | W24 | 1 Participants |
| Juvéderm® Ultra XC (RHA GA) | Number of Subjects Receiving Re-treatment | W24 | 1 Participants |
| Juvéderm® Ultra XC (RHA GA) | Number of Subjects Receiving Re-treatment | W64 | 43 Participants |
| Juvéderm® Ultra XC (RHA GA) | Number of Subjects Receiving Re-treatment | W52 | 11 Participants |
| Juvéderm® Ultra XC (RHA GA) | Number of Subjects Receiving Re-treatment | W36 | 3 Participants |
| TEOSYAL® RHA Deep Lines | Number of Subjects Receiving Re-treatment | W64 | 39 Participants |
| TEOSYAL® RHA Deep Lines | Number of Subjects Receiving Re-treatment | W24 | 0 Participants |
| TEOSYAL® RHA Deep Lines | Number of Subjects Receiving Re-treatment | W52 | 9 Participants |
| TEOSYAL® RHA Deep Lines | Number of Subjects Receiving Re-treatment | W36 | 5 Participants |
| Juvéderm® Ultra XC (RHA DL) | Number of Subjects Receiving Re-treatment | W52 | 9 Participants |
| Juvéderm® Ultra XC (RHA DL) | Number of Subjects Receiving Re-treatment | W36 | 5 Participants |
| Juvéderm® Ultra XC (RHA DL) | Number of Subjects Receiving Re-treatment | W24 | 0 Participants |
| Juvéderm® Ultra XC (RHA DL) | Number of Subjects Receiving Re-treatment | W64 | 38 Participants |
Secondary
Number of Subjects Receiving Touch-up Treatment.
Time frame: Week 2
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TEOSYAL® RHA Global Action | Number of Subjects Receiving Touch-up Treatment. | 43 Participants |
| Juvéderm® Ultra XC (RHA GA) | Number of Subjects Receiving Touch-up Treatment. | 45 Participants |
| TEOSYAL® RHA Deep Lines | Number of Subjects Receiving Touch-up Treatment. | 45 Participants |
| Juvéderm® Ultra XC (RHA DL) | Number of Subjects Receiving Touch-up Treatment. | 47 Participants |
Secondary
Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE).
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.
Time frame: Weeks 24, 36, 52, 64
Population: Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available (See participant flow)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TEOSYAL® RHA Global Action | Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE). | W24 | 61 Participants |
| TEOSYAL® RHA Global Action | Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE). | W36 | 60 Participants |
| TEOSYAL® RHA Global Action | Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE). | W52 | 57 Participants |
| TEOSYAL® RHA Global Action | Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE). | W64 | 41 Participants |
| Juvéderm® Ultra XC (RHA GA) | Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE). | W36 | 61 Participants |
| Juvéderm® Ultra XC (RHA GA) | Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE). | W52 | 54 Participants |
| Juvéderm® Ultra XC (RHA GA) | Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE). | W64 | 39 Participants |
| Juvéderm® Ultra XC (RHA GA) | Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE). | W24 | 59 Participants |
| 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). | W52 | 46 Participants |
| 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). | W36 | 53 Participants |
| 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). | W64 | 40 Participants |
| 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 | 59 Participants |
| Juvéderm® Ultra XC (RHA DL) | Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE). | W64 | 37 Participants |
| Juvéderm® Ultra XC (RHA DL) | Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE). | W36 | 50 Participants |
| Juvéderm® Ultra XC (RHA DL) | Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE). | W24 | 58 Participants |
| Juvéderm® Ultra XC (RHA DL) | Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE). | W52 | 44 Participants |
Secondary
Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the WSRS Compared to Baseline Assessed by the BLE
A responder correspond to a subject with an intra-individual improvement of at least one grade in the WSRS compared to baseline
Time frame: Baseline and Weeks 24, 36, 52, 64
Population: Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available (See participant flow)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TEOSYAL® RHA Global Action | 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 |
| TEOSYAL® RHA Global Action | 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 |
| TEOSYAL® RHA Global Action | 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 |
| TEOSYAL® RHA Global Action | 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 |
| Juvéderm® Ultra XC (RHA GA) | 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 | 87.7 percentage of responders |
| Juvéderm® Ultra XC (RHA GA) | 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 | 82.3 percentage of responders |
| Juvéderm® Ultra XC (RHA GA) | 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 |
| Juvéderm® Ultra XC (RHA GA) | 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 | 82.1 percentage of responders |
| 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 | 75.0 percentage of responders |
| 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 | W36 | 82.8 percentage of responders |
| 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 | W64 | 78.7 percentage of responders |
| 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 | W24 | 91.9 percentage of responders |
| Juvéderm® Ultra XC (RHA DL) | 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 | 72.3 percentage of responders |
| Juvéderm® Ultra XC (RHA DL) | 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 | 79.3 percentage of responders |
| Juvéderm® Ultra XC (RHA DL) | 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 | 88.7 percentage of responders |
| Juvéderm® Ultra XC (RHA DL) | 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 | 69.6 percentage of responders |
Secondary
Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the WSRS Compared to Baseline Assessed by the TI
A responder correspond to a subject with an intra-individual improvement of at least one grade in the WSRS compared to baseline
Time frame: Baseline and Weeks 2, 4, 12, 24, 36, 52, 64
Population: Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available (See participant flow)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TEOSYAL® RHA Global Action | 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 |
| TEOSYAL® RHA Global Action | 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 |
| TEOSYAL® RHA Global Action | 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 |
| TEOSYAL® RHA Global Action | 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 |
| TEOSYAL® RHA Global Action | 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 |
| TEOSYAL® RHA Global Action | 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 |
| TEOSYAL® RHA Global Action | 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 |
| Juvéderm® Ultra XC (RHA GA) | 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 | 87.3 percentage of responders |
| Juvéderm® Ultra XC (RHA GA) | 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 | 86.6 percentage of responders |
| Juvéderm® Ultra XC (RHA GA) | 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 | 87.7 percentage of responders |
| Juvéderm® Ultra XC (RHA GA) | 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 | 83.1 percentage of responders |
| Juvéderm® Ultra XC (RHA GA) | 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 | 80.9 percentage of responders |
| Juvéderm® Ultra XC (RHA GA) | 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 |
| Juvéderm® Ultra XC (RHA GA) | 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 | 91.0 percentage of responders |
| 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 | W24 | 96.8 percentage of responders |
| 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 | 95.2 percentage of responders |
| 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 | W4 | 100.0 percentage of responders |
| 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 | W12 | 100.0 percentage of responders |
| 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 | W36 | 83.1 percentage of responders |
| 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 | W52 | 80.4 percentage of responders |
| 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 | W64 | 83.0 percentage of responders |
| Juvéderm® Ultra XC (RHA DL) | 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 | 100.0 percentage of responders |
| Juvéderm® Ultra XC (RHA DL) | 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 | 74.5 percentage of responders |
| Juvéderm® Ultra XC (RHA DL) | 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 | 80.4 percentage of responders |
| Juvéderm® Ultra XC (RHA DL) | 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 | 100.0 percentage of responders |
| Juvéderm® Ultra XC (RHA DL) | 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 | 93.6 percentage of responders |
| Juvéderm® Ultra XC (RHA DL) | 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 | 79.7 percentage of responders |
| Juvéderm® Ultra XC (RHA DL) | 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 | 98.4 percentage of responders |
Secondary
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).
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)
Time frame: 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)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TEOSYAL® RHA Global Action | 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 |
| TEOSYAL® RHA Global Action | 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 |
| TEOSYAL® RHA Global Action | 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 |
| TEOSYAL® RHA Global Action | 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 |
| TEOSYAL® RHA Global Action | 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 |
| TEOSYAL® RHA Global Action | 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 |
| TEOSYAL® RHA Global Action | 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 |
| TEOSYAL® RHA Global Action | 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 |
| TEOSYAL® RHA Global Action | 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 |
| TEOSYAL® RHA Global Action | 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 |
| TEOSYAL® RHA Global Action | 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 |
| TEOSYAL® RHA Global Action | 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 |
| TEOSYAL® RHA Global Action | 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 |
| TEOSYAL® RHA Global Action | 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 |
| TEOSYAL® RHA Global Action | 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 |
| TEOSYAL® RHA Global Action | 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 |
| TEOSYAL® RHA Global Action | 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 |
| TEOSYAL® RHA Global Action | 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 |
| Juvéderm® Ultra XC (RHA GA) | 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) | 27 Participants |
| Juvéderm® Ultra XC (RHA GA) | 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) | 41 Participants |
| Juvéderm® Ultra XC (RHA GA) | 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) | 13 Participants |
| Juvéderm® Ultra XC (RHA GA) | 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) | 13 Participants |
| Juvéderm® Ultra XC (RHA GA) | 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) | 48 Participants |
| Juvéderm® Ultra XC (RHA GA) | 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) | 20 Participants |
| Juvéderm® Ultra XC (RHA GA) | 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) | 15 Participants |
| Juvéderm® Ultra XC (RHA GA) | 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) | 4 Participants |
| Juvéderm® Ultra XC (RHA GA) | 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) | 37 Participants |
| Juvéderm® Ultra XC (RHA GA) | 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) | 17 Participants |
| Juvéderm® Ultra XC (RHA GA) | 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) | 16 Participants |
| Juvéderm® Ultra XC (RHA GA) | 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) | 9 Participants |
| Juvéderm® Ultra XC (RHA GA) | 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) | 49 Participants |
| Juvéderm® Ultra XC (RHA GA) | 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) | 16 Participants |
| Juvéderm® Ultra XC (RHA GA) | 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) | 45 Participants |
| Juvéderm® Ultra XC (RHA GA) | 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) | 22 Participants |
| Juvéderm® Ultra XC (RHA GA) | 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) | 40 Participants |
| Juvéderm® Ultra XC (RHA GA) | 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) | 18 Participants |
| 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). | Firmness (initial treatment) | 48 Participants |
| 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). | Lumps/Bumps (Touch-up) | 30 Participants |
| 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). | Pain (initial treatment) | 30 Participants |
| 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). | Discolouration (Touch-up) | 10 Participants |
| 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). | Tenderness (Touch-up) | 29 Participants |
| 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). | Pain (Touch-up) | 16 Participants |
| 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). | Tenderness (Initial treatment) | 44 Participants |
| 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). | Redness (initial treatment) | 43 Participants |
| 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). | Discolouration (initial treatment) | 22 Participants |
| 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). | Redness (Touch-up) | 27 Participants |
| 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) | 42 Participants |
| 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). | Swelling (initial treatment) | 41 Participants |
| 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 (Touch-up) | 19 Participants |
| 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). | Itching (initial treatment) | 13 Participants |
| 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). | Firmness (Touch-up) | 34 Participants |
| 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). | Itching (Touch-up) | 5 Participants |
| 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). | Swelling (Touch-up) | 31 Participants |
| 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). | Lumps/Bumps (initial treatment) | 49 Participants |
| Juvéderm® Ultra XC (RHA DL) | 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) | 11 Participants |
| Juvéderm® Ultra XC (RHA DL) | 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) | 31 Participants |
| Juvéderm® Ultra XC (RHA DL) | 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) | 25 Participants |
| Juvéderm® Ultra XC (RHA DL) | 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) | 24 Participants |
| Juvéderm® Ultra XC (RHA DL) | 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) | 12 Participants |
| Juvéderm® Ultra XC (RHA DL) | 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) | 38 Participants |
| Juvéderm® Ultra XC (RHA DL) | 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) | 20 Participants |
| Juvéderm® Ultra XC (RHA DL) | 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) | 23 Participants |
| Juvéderm® Ultra XC (RHA DL) | 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) | 45 Participants |
| Juvéderm® Ultra XC (RHA DL) | 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) | 27 Participants |
| Juvéderm® Ultra XC (RHA DL) | 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) | 38 Participants |
| Juvéderm® Ultra XC (RHA DL) | 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) | 19 Participants |
| Juvéderm® Ultra XC (RHA DL) | 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) | 22 Participants |
| Juvéderm® Ultra XC (RHA DL) | 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) | 31 Participants |
| Juvéderm® Ultra XC (RHA DL) | 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) | 40 Participants |
| Juvéderm® Ultra XC (RHA DL) | 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) | 42 Participants |
| Juvéderm® Ultra XC (RHA DL) | 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 |
| Juvéderm® Ultra XC (RHA DL) | 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) | 37 Participants |
Secondary
Subject's Perception of Treatment Effectiveness as Per the FACE-Q (NLF Domain) Questionnaire
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.
Time frame: Immediately post-injection, and weeks 2, 4, 12, 24, 36, 52, 64
Population: Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available (See participant flow)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TEOSYAL® RHA Global Action | 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 |
| TEOSYAL® RHA Global Action | 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 |
| TEOSYAL® RHA Global Action | 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 |
| TEOSYAL® RHA Global Action | 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 |
| TEOSYAL® RHA Global Action | 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 |
| TEOSYAL® RHA Global Action | 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 |
| TEOSYAL® RHA Global Action | 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 |
| TEOSYAL® RHA Global Action | 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 |
| Juvéderm® Ultra XC (RHA GA) | Subject's Perception of Treatment Effectiveness as Per the FACE-Q (NLF Domain) Questionnaire | W36 | 61.4 units on a scale | Standard Deviation 25.1 |
| Juvéderm® Ultra XC (RHA GA) | Subject's Perception of Treatment Effectiveness as Per the FACE-Q (NLF Domain) Questionnaire | W24 | 62.9 units on a scale | Standard Deviation 24.5 |
| Juvéderm® Ultra XC (RHA GA) | Subject's Perception of Treatment Effectiveness as Per the FACE-Q (NLF Domain) Questionnaire | W2 | 69.0 units on a scale | Standard Deviation 22.2 |
| Juvéderm® Ultra XC (RHA GA) | Subject's Perception of Treatment Effectiveness as Per the FACE-Q (NLF Domain) Questionnaire | W64 | 59.5 units on a scale | Standard Deviation 22.4 |
| Juvéderm® Ultra XC (RHA GA) | Subject's Perception of Treatment Effectiveness as Per the FACE-Q (NLF Domain) Questionnaire | W52 | 61.8 units on a scale | Standard Deviation 30 |
| Juvéderm® Ultra XC (RHA GA) | Subject's Perception of Treatment Effectiveness as Per the FACE-Q (NLF Domain) Questionnaire | W12 | 73.1 units on a scale | Standard Deviation 23.7 |
| Juvéderm® Ultra XC (RHA GA) | Subject's Perception of Treatment Effectiveness as Per the FACE-Q (NLF Domain) Questionnaire | W4 | 75.6 units on a scale | Standard Deviation 22 |
| Juvéderm® Ultra XC (RHA GA) | Subject's Perception of Treatment Effectiveness as Per the FACE-Q (NLF Domain) Questionnaire | pre-treatment | 25.2 units on a scale | Standard Deviation 16.5 |
| TEOSYAL® RHA Deep Lines | Subject's Perception of Treatment Effectiveness as Per the FACE-Q (NLF Domain) Questionnaire | W52 | 63.0 units on a scale | Standard Deviation 27.4 |
| TEOSYAL® RHA Deep Lines | Subject's Perception of Treatment Effectiveness as Per the FACE-Q (NLF Domain) Questionnaire | W4 | 77.5 units on a scale | Standard Deviation 20.4 |
| TEOSYAL® RHA Deep Lines | Subject's Perception of Treatment Effectiveness as Per the FACE-Q (NLF Domain) Questionnaire | W12 | 77.5 units on a scale | Standard Deviation 21.8 |
| TEOSYAL® RHA Deep Lines | Subject's Perception of Treatment Effectiveness as Per the FACE-Q (NLF Domain) Questionnaire | W24 | 64.8 units on a scale | Standard Deviation 24.5 |
| TEOSYAL® RHA Deep Lines | Subject's Perception of Treatment Effectiveness as Per the FACE-Q (NLF Domain) Questionnaire | W36 | 66.0 units on a scale | Standard Deviation 26.4 |
| TEOSYAL® RHA Deep Lines | Subject's Perception of Treatment Effectiveness as Per the FACE-Q (NLF Domain) Questionnaire | W64 | 64.1 units on a scale | Standard Deviation 25.2 |
| TEOSYAL® RHA Deep Lines | Subject's Perception of Treatment Effectiveness as Per the FACE-Q (NLF Domain) Questionnaire | pre-treatment | 29.1 units on a scale | Standard Deviation 17 |
| TEOSYAL® RHA Deep Lines | Subject's Perception of Treatment Effectiveness as Per the FACE-Q (NLF Domain) Questionnaire | W2 | 67.4 units on a scale | Standard Deviation 25.5 |
| Juvéderm® Ultra XC (RHA DL) | Subject's Perception of Treatment Effectiveness as Per the FACE-Q (NLF Domain) Questionnaire | W4 | 78.0 units on a scale | Standard Deviation 20.4 |
| Juvéderm® Ultra XC (RHA DL) | Subject's Perception of Treatment Effectiveness as Per the FACE-Q (NLF Domain) Questionnaire | W12 | 77.2 units on a scale | Standard Deviation 21.9 |
| Juvéderm® Ultra XC (RHA DL) | Subject's Perception of Treatment Effectiveness as Per the FACE-Q (NLF Domain) Questionnaire | W2 | 66.9 units on a scale | Standard Deviation 25.3 |
| Juvéderm® Ultra XC (RHA DL) | Subject's Perception of Treatment Effectiveness as Per the FACE-Q (NLF Domain) Questionnaire | pre-treatment | 27.7 units on a scale | Standard Deviation 17.8 |
| Juvéderm® Ultra XC (RHA DL) | Subject's Perception of Treatment Effectiveness as Per the FACE-Q (NLF Domain) Questionnaire | W24 | 66.2 units on a scale | Standard Deviation 23.7 |
| Juvéderm® Ultra XC (RHA DL) | Subject's Perception of Treatment Effectiveness as Per the FACE-Q (NLF Domain) Questionnaire | W64 | 62.7 units on a scale | Standard Deviation 24.9 |
| Juvéderm® Ultra XC (RHA DL) | Subject's Perception of Treatment Effectiveness as Per the FACE-Q (NLF Domain) Questionnaire | W52 | 60.5 units on a scale | Standard Deviation 27.6 |
| Juvéderm® Ultra XC (RHA DL) | Subject's Perception of Treatment Effectiveness as Per the FACE-Q (NLF Domain) Questionnaire | W36 | 65.3 units on a scale | Standard Deviation 25.2 |
Secondary
Subject's Satisfaction Score
Subjective 5-point scale with 1 being 'very satisfied' and 5 being 'very dissatisfied'
Time frame: Weeks 2, 4, 12, 24, 36, 52, 64
Population: Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available (See participant flow)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TEOSYAL® RHA Global Action | Subject's Satisfaction Score | W2 | 1.58 units on a scale | Standard Deviation 0.72 |
| TEOSYAL® RHA Global Action | Subject's Satisfaction Score | W52 | 1.47 units on a scale | Standard Deviation 0.69 |
| TEOSYAL® RHA Global Action | Subject's Satisfaction Score | W36 | 1.66 units on a scale | Standard Deviation 0.76 |
| TEOSYAL® RHA Global Action | Subject's Satisfaction Score | W4 | 1.29 units on a scale | Standard Deviation 0.49 |
| TEOSYAL® RHA Global Action | Subject's Satisfaction Score | W64 | 1.68 units on a scale | Standard Deviation 0.75 |
| TEOSYAL® RHA Global Action | Subject's Satisfaction Score | W12 | 1.46 units on a scale | Standard Deviation 0.64 |
| TEOSYAL® RHA Global Action | Subject's Satisfaction Score | W24 | 1.73 units on a scale | Standard Deviation 0.73 |
| Juvéderm® Ultra XC (RHA GA) | Subject's Satisfaction Score | W52 | 1.58 units on a scale | Standard Deviation 0.78 |
| Juvéderm® Ultra XC (RHA GA) | Subject's Satisfaction Score | W24 | 1.75 units on a scale | Standard Deviation 0.75 |
| Juvéderm® Ultra XC (RHA GA) | Subject's Satisfaction Score | W12 | 1.55 units on a scale | Standard Deviation 0.71 |
| Juvéderm® Ultra XC (RHA GA) | Subject's Satisfaction Score | W36 | 1.69 units on a scale | Standard Deviation 0.75 |
| Juvéderm® Ultra XC (RHA GA) | Subject's Satisfaction Score | W64 | 1.66 units on a scale | Standard Deviation 0.7 |
| Juvéderm® Ultra XC (RHA GA) | Subject's Satisfaction Score | W4 | 1.29 units on a scale | Standard Deviation 0.49 |
| Juvéderm® Ultra XC (RHA GA) | Subject's Satisfaction Score | W2 | 1.57 units on a scale | Standard Deviation 0.74 |
| TEOSYAL® RHA Deep Lines | Subject's Satisfaction Score | W24 | 1.63 units on a scale | Standard Deviation 0.83 |
| TEOSYAL® RHA Deep Lines | Subject's Satisfaction Score | W2 | 1.87 units on a scale | Standard Deviation 0.78 |
| TEOSYAL® RHA Deep Lines | Subject's Satisfaction Score | W4 | 1.43 units on a scale | Standard Deviation 0.67 |
| TEOSYAL® RHA Deep Lines | Subject's Satisfaction Score | W12 | 1.50 units on a scale | Standard Deviation 0.76 |
| TEOSYAL® RHA Deep Lines | Subject's Satisfaction Score | W36 | 1.56 units on a scale | Standard Deviation 0.82 |
| TEOSYAL® RHA Deep Lines | Subject's Satisfaction Score | W52 | 1.55 units on a scale | Standard Deviation 0.93 |
| TEOSYAL® RHA Deep Lines | Subject's Satisfaction Score | W64 | 1.36 units on a scale | Standard Deviation 0.67 |
| Juvéderm® Ultra XC (RHA DL) | Subject's Satisfaction Score | W12 | 1.50 units on a scale | Standard Deviation 0.7 |
| Juvéderm® Ultra XC (RHA DL) | Subject's Satisfaction Score | W64 | 1.45 units on a scale | Standard Deviation 0.75 |
| Juvéderm® Ultra XC (RHA DL) | Subject's Satisfaction Score | W52 | 1.66 units on a scale | Standard Deviation 0.82 |
| Juvéderm® Ultra XC (RHA DL) | Subject's Satisfaction Score | W4 | 1.34 units on a scale | Standard Deviation 0.54 |
| Juvéderm® Ultra XC (RHA DL) | Subject's Satisfaction Score | W2 | 1.81 units on a scale | Standard Deviation 0.7 |
| Juvéderm® Ultra XC (RHA DL) | Subject's Satisfaction Score | W36 | 1.63 units on a scale | Standard Deviation 0.83 |
| Juvéderm® Ultra XC (RHA DL) | Subject's Satisfaction Score | W24 | 1.55 units on a scale | Standard Deviation 0.74 |
Secondary
Volume to Obtain Optimal Cosmetic Result (Initial Treatment + Touch-up)
Time frame: Week 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TEOSYAL® RHA Global Action | Volume to Obtain Optimal Cosmetic Result (Initial Treatment + Touch-up) | 1.54 mL | Standard Deviation 0.66 |
| Juvéderm® Ultra XC (RHA GA) | Volume to Obtain Optimal Cosmetic Result (Initial Treatment + Touch-up) | 1.30 mL | Standard Deviation 0.53 |
| TEOSYAL® RHA Deep Lines | Volume to Obtain Optimal Cosmetic Result (Initial Treatment + Touch-up) | 1.52 mL | Standard Deviation 0.62 |
| Juvéderm® Ultra XC (RHA DL) | Volume to Obtain Optimal Cosmetic Result (Initial Treatment + Touch-up) | 1.30 mL | Standard Deviation 0.55 |