| 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 | | Posted | | Mean | 97.5% Confidence Interval | units on a scale | | Baseline and 24 weeks after last treatment | | | | ID | Title | Description |
|---|
| OG000 | TEOSYAL® RHA Global Action | Injection of TEOSYAL® RHA Global Action into one NLF | | OG001 | Juvéderm® Ultra XC (RHA GA) | Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Global Action | | OG002 | TEOSYAL® RHA Deep Lines | Injection of TEOSYAL® RHA Deep Lines into one NLF | | OG003 | Juvéderm® Ultra XC (RHA DL) | Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Deep Lines |
| | Units | Counts |
|---|
| Participants | - OG00067
- OG00167
- OG00262
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-1.16(-1.36 to -0.97)
- OG001-1.13(-1.33 to -0.93)
- OG002-1.32(-1.53 to -1.12)
- OG003
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| 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. | | | | | Mean Difference (Final Values) | -0.03 | | | 2-Sided | 97.5 | -0.17 | 0.11 | | | The decision is based on the upper limit of the 2-sided confidence interval for the difference for the change from baseline, between test and comparator treatment. For achieving non-inferiority, the upper confidence limit of a 97.5% CI must be ≤0.5 |
|
| 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) | 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) | Posted | | Count of Participants | | Participants | | During 14 days after initial treatment (D0) and touch-up (2 weeks) | | | | ID | Title | Description |
|---|
| OG000 | TEOSYAL® RHA Global Action | Injection of TEOSYAL® RHA Global Action into one NLF |
|
| 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 | 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) | Posted | | Mean | Standard Deviation | VAS score | | During Injection and 5, 15, 30 minutes post-injection | | | | ID | Title | Description |
|---|
| OG000 | TEOSYAL® RHA Global Action | Injection of TEOSYAL® RHA Global Action into one NLF | | OG001 | Juvéderm® Ultra XC (RHA GA) | Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Global Action | | OG002 | TEOSYAL® RHA Deep Lines | Injection of TEOSYAL® RHA Deep Lines into one NLF | | OG003 | Juvéderm® Ultra XC (RHA DL) |
|
| 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 | Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available (See participant flow) | Posted | | Mean | Standard Deviation | WSRS Delta from V1 | | Baseline and Weeks 24, 36, 52, 64 | | | | ID | Title | Description |
|---|
| OG000 | TEOSYAL® RHA Global Action | Injection of TEOSYAL® RHA Global Action into one NLF | | OG001 | Juvéderm® Ultra XC (RHA GA) | Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Global Action | | OG002 | TEOSYAL® RHA Deep Lines | Injection of TEOSYAL® RHA Deep Lines into one NLF | | OG003 |
|
| 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 | Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available (See participant flow) | Posted | | Mean | Standard Deviation | WSRS Delta from V1 | | Baseline and Weeks 2, 4, 12, 24, 36, 52, 64 | | | | ID | Title | Description |
|---|
| OG000 | TEOSYAL® RHA Global Action | Injection of TEOSYAL® RHA Global Action into one NLF | | OG001 | Juvéderm® Ultra XC (RHA GA) | Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Global Action | | OG002 | TEOSYAL® RHA Deep Lines | Injection of TEOSYAL® RHA Deep Lines into one NLF | | OG003 |
|
| 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 | Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available (See participant flow) | Posted | | Number | 95% Confidence Interval | percentage of responders | | Baseline and Weeks 24, 36, 52, 64 | | | | ID | Title | Description |
|---|
| OG000 | TEOSYAL® RHA Global Action | Injection of TEOSYAL® RHA Global Action into one NLF | | OG001 | Juvéderm® Ultra XC (RHA GA) | Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Global Action | | OG002 | TEOSYAL® RHA Deep Lines | Injection of TEOSYAL® RHA Deep Lines into one NLF | | OG003 | Juvéderm® Ultra XC (RHA DL) | Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Deep Lines |
|
| 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 | Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available (See participant flow) | Posted | | Number | 95% Confidence Interval | percentage of responders | | Baseline and Weeks 2, 4, 12, 24, 36, 52, 64 | | | | ID | Title | Description |
|---|
| OG000 | TEOSYAL® RHA Global Action | Injection of TEOSYAL® RHA Global Action into one NLF | | OG001 | Juvéderm® Ultra XC (RHA GA) | Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Global Action | | OG002 | TEOSYAL® RHA Deep Lines | Injection of TEOSYAL® RHA Deep Lines into one NLF | | OG003 | Juvéderm® Ultra XC (RHA DL) | Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Deep Lines |
|
| 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. | Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available (See participant flow) | Posted | | Count of Participants | | Participants | | Weeks 24, 36, 52, 64 | | | | ID | Title | Description |
|---|
| OG000 | TEOSYAL® RHA Global Action | Injection of TEOSYAL® RHA Global Action into one NLF | | OG001 | Juvéderm® Ultra XC (RHA GA) | Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Global Action | | OG002 | TEOSYAL® RHA Deep Lines | Injection of TEOSYAL® RHA Deep Lines into one NLF | | OG003 | Juvéderm® Ultra XC (RHA DL) |
|
| 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. | Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available (See participant flow) | Posted | | Count of Participants | | Participants | | Weeks 4, 12, 24, 36, 52, 64 | | | | ID | Title | Description |
|---|
| OG000 | TEOSYAL® RHA Global Action | Injection of TEOSYAL® RHA Global Action into one NLF | | OG001 | Juvéderm® Ultra XC (RHA GA) | Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Global Action | | OG002 | TEOSYAL® RHA Deep Lines | Injection of TEOSYAL® RHA Deep Lines into one NLF |
|
| 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.
| Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available (See participant flow) | Posted | | Mean | Standard Deviation | units on a scale | | Immediately post-injection, and weeks 2, 4, 12, 24, 36, 52, 64 | | | | ID | Title | Description |
|---|
| OG000 | TEOSYAL® RHA Global Action | Injection of TEOSYAL® RHA Global Action into one NLF | | OG001 | Juvéderm® Ultra XC (RHA GA) | |
|
| Secondary | Subject's Satisfaction Score | Subjective 5-point scale with 1 being 'very satisfied' and 5 being 'very dissatisfied' | Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available (See participant flow) | Posted | | Mean | Standard Deviation | units on a scale | | Weeks 2, 4, 12, 24, 36, 52, 64 | | | | ID | Title | Description |
|---|
| OG000 | TEOSYAL® RHA Global Action | Injection of TEOSYAL® RHA Global Action into one NLF | | OG001 | Juvéderm® Ultra XC (RHA GA) | Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Global Action | | OG002 | TEOSYAL® RHA Deep Lines | Injection of TEOSYAL® RHA Deep Lines into one NLF | | OG003 | Juvéderm® Ultra XC (RHA DL) | Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Deep Lines |
| |
| Secondary | Volume to Obtain Optimal Cosmetic Result (Initial Treatment + Touch-up) | | | Posted | | Mean | Standard Deviation | mL | | Week 2 | | | | ID | Title | Description |
|---|
| OG000 | TEOSYAL® RHA Global Action | Injection of TEOSYAL® RHA Global Action into one NLF | | OG001 | Juvéderm® Ultra XC (RHA GA) | Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Global Action | | OG002 | TEOSYAL® RHA Deep Lines | Injection of TEOSYAL® RHA Deep Lines into one NLF | | OG003 | Juvéderm® Ultra XC (RHA DL) | Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Deep Lines |
| |
| Secondary | Number of Subjects Receiving Touch-up Treatment. | | | Posted | | Count of Participants | | Participants | | Week 2 | | | | ID | Title | Description |
|---|
| OG000 | TEOSYAL® RHA Global Action | Injection of TEOSYAL® RHA Global Action into one NLF | | OG001 | Juvéderm® Ultra XC (RHA GA) | Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Global Action | | OG002 | TEOSYAL® RHA Deep Lines | Injection of TEOSYAL® RHA Deep Lines into one NLF | | OG003 | Juvéderm® Ultra XC (RHA DL) | Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Deep Lines |
| |
| Secondary | Number of Subjects Receiving Re-treatment | | Numbers of patients analyzed correspond to patients that have completed the visits (See participant flow) | Posted | | Count of Participants | | Participants | | Weeks 24, 36, 52, 64 | | | | ID | Title | Description |
|---|
| OG000 | TEOSYAL® RHA Global Action | Injection of TEOSYAL® RHA Global Action into one NLF | | OG001 | Juvéderm® Ultra XC (RHA GA) | Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Global Action | | OG002 | TEOSYAL® RHA Deep Lines | Injection of TEOSYAL® RHA Deep Lines into one NLF | | OG003 | Juvéderm® Ultra XC (RHA DL) | Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Deep Lines |
| |