Nasolabial Folds, Wrinkles
Conditions
Keywords
Nasolabial folds, Dermal filler, Hyaluronic acid (HA), Wrinkles
Brief summary
The purpose of this study is to compare the effectiveness and safety of TEOSYAL® RHA Ultra Deep versus Perlane-L® in the treatment of moderate to severe nasolabial folds. This is a controlled, randomized, double-blinded, within subject (split-face), multicenter, prospective clinical study.
Interventions
DEVICETEOSYAL® RHA Ultra Deep
A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus equi bacteria, formulated to a concentration of 23 mg/mL and 0.3% w/w lidocaine in a physiologic buffer. It is supplied in individual treatment syringes with 27Gauge ½ 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 form.
Exclusion criteria
* Female subjects that are pregnant, 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, ASA, 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). * Evidence of 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 the WSRS Score Between W24 and Baseline for TEOSYAL® RHA Ultra Deep Versus Perlane-L® for the Correction of Moderate to Severe Naso-Labial Folds Based on the Wrinkle Severity Rating Scale (WSRS) Score Assessed by the BLE. | Baseline and 24 weeks after last treatment | WSRS (Wrinkle Severity Rating Scale) is a validated 5-point scale 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 Ultra Deep Versus Perlane-L® | 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 64 and Baseline for TEOSYAL® RHA Ultra Deep Versus Perlane-L® for the Correction of Moderate to Severe NLFs Based on the Wrinkle Severity Rating Scale (WSRS) Score Assessed by the Blinded Live Evaluator (BLE) | Baseline and Weeks 24, 36, 52, 64 | WSRS (Wrinkle Severity Rating Scale) is a validated 5-point scale with 1 being 'absent' and 5 being 'extreme'. |
| Delta of the WSRS Score Between W2,4,12,24,36,52,64 and Baseline for TEOSYAL® RHA Ultra Deep Versus Perlane-L® for the Correction of Moderate to Severe NLFs Based on the Wrinkle Severity Rating Scale (WSRS) Score Assessed by the Treating Investigator (TI) | Baseline and Weeks 2, 4, 12, 24, 36, 52, 64 | WSRS (Wrinkle Severity Rating Scale) is a validated 5-point scale with 1 being 'absent' and 5 being 'extreme'. |
| Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the Wrinkle Severity Rating Scale (WSRS) Compared to Baseline Assessed by the BLE | 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 Wrinkle Severity Rating Scale (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) 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. 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 Ultra Deep Versus Perlane-L® | 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. 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 120 were randomized for a split-face injection of RHA Ultra Deep and Perlane-L. 20 subjects were randomized to an untreated group (recruited only to avoid Blinded Live Evaluator to be biased so, not presented)
Pre-assignment details
2 subjects randomized to the RHA UD/Perlane discontinued participation prior to receiving study treatment (N=118) 2 subjects randomized to the untreated group received injections with RHA UD/Perlane. These subjects were placed in the SAFT population for safety evaluations (SAFT population n=120)
Participants by arm
| Arm | Count |
|---|---|
| TEOSYAL® RHA Ultra Deep / Perlane-L® Split-face injection of TEOSYAL® RHA Ultra Deep into one NLF and Perlane-L® into the contralateral NLF. Up to 3.0 mL injected per NLF (deep-dermis to superficial subcutaneous). Touch-up treatment provided at 2 weeks (up to 3.0 mL per NLF).
TEOSYAL® RHA Ultra Deep: A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus equi bacteria, formulated to a concentration of 23 mg/mL and 0.3% w/w lidocaine in a physiologic buffer. It is supplied in individual treatment syringes with 27G½ disposable sterile needles. | 118 |
| Total | 118 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Conditional re-treatment at W52 | 5 |
| Overall Study | Did not consent to study extension | 9 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Protocol Violation | 30 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | TEOSYAL® RHA Ultra Deep / Perlane-L® |
|---|---|
| Age, Continuous | 57.4 years STANDARD_DEVIATION 10 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 30 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 88 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Fitzpatrick Skin Type Types I to III | 65 Participants |
| Fitzpatrick Skin Type Types IV to VI | 53 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 19 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 97 Participants |
| Region of Enrollment United States | 118 Participants |
| Sex: Female, Male Female | 106 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 75 / 120 | 74 / 120 |
| serious Total, serious adverse events | 3 / 120 | 3 / 120 |
Outcome results
Primary
Non-inferiority of the Delta of the WSRS Score Between W24 and Baseline for TEOSYAL® RHA Ultra Deep Versus Perlane-L® for the Correction of Moderate to Severe Naso-Labial Folds Based on the Wrinkle Severity Rating Scale (WSRS) Score Assessed by the BLE.
WSRS (Wrinkle Severity Rating Scale) is a validated 5-point scale 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 Ultra Deep | Non-inferiority of the Delta of the WSRS Score Between W24 and Baseline for TEOSYAL® RHA Ultra Deep Versus Perlane-L® for the Correction of Moderate to Severe Naso-Labial Folds Based on the Wrinkle Severity Rating Scale (WSRS) Score Assessed by the BLE. | -1.34 units on a scale |
| Perlane-L® | Non-inferiority of the Delta of the WSRS Score Between W24 and Baseline for TEOSYAL® RHA Ultra Deep Versus Perlane-L® for the Correction of Moderate to Severe Naso-Labial Folds Based on the Wrinkle Severity Rating Scale (WSRS) Score Assessed by the BLE. | -1.16 units on a scale |
Comparison: Efficacy of TEOSYAL® RHA Ultra Deep 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.95% CI: [-0.34, -0.11]
Secondary
Assessment of Injection Site Pain (Visual Analog Scale) of TEOSYAL® RHA Ultra Deep Versus Perlane-L®
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: VAS are presented for the SAFT population (N=120) (see pre-assignment details) Number of patients for pain assessment after touch-up treatment are based on number of patients receiving Touch-up treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TEOSYAL® RHA Ultra Deep | Assessment of Injection Site Pain (Visual Analog Scale) of TEOSYAL® RHA Ultra Deep Versus Perlane-L® | Initial injection mean pain during injection | 23.43 units on a scale | Standard Deviation 21.15 |
| TEOSYAL® RHA Ultra Deep | Assessment of Injection Site Pain (Visual Analog Scale) of TEOSYAL® RHA Ultra Deep Versus Perlane-L® | Initial injection mean pain 5 min post-injection | 6.22 units on a scale | Standard Deviation 12.37 |
| TEOSYAL® RHA Ultra Deep | Assessment of Injection Site Pain (Visual Analog Scale) of TEOSYAL® RHA Ultra Deep Versus Perlane-L® | Initial injection mean pain 15 min post-injection | 2.67 units on a scale | Standard Deviation 7.38 |
| TEOSYAL® RHA Ultra Deep | Assessment of Injection Site Pain (Visual Analog Scale) of TEOSYAL® RHA Ultra Deep Versus Perlane-L® | Initial injection mean pain 30 min post-injection | 1.83 units on a scale | Standard Deviation 7.31 |
| TEOSYAL® RHA Ultra Deep | Assessment of Injection Site Pain (Visual Analog Scale) of TEOSYAL® RHA Ultra Deep Versus Perlane-L® | Touch-up injection mean pain during injection | 23.63 units on a scale | Standard Deviation 23.06 |
| TEOSYAL® RHA Ultra Deep | Assessment of Injection Site Pain (Visual Analog Scale) of TEOSYAL® RHA Ultra Deep Versus Perlane-L® | Touch-up injection mean pain 5 min post-injection | 8.88 units on a scale | Standard Deviation 14.46 |
| TEOSYAL® RHA Ultra Deep | Assessment of Injection Site Pain (Visual Analog Scale) of TEOSYAL® RHA Ultra Deep Versus Perlane-L® | Touch-up injection mean pain 15 min post-injection | 3.56 units on a scale | Standard Deviation 6.48 |
| TEOSYAL® RHA Ultra Deep | Assessment of Injection Site Pain (Visual Analog Scale) of TEOSYAL® RHA Ultra Deep Versus Perlane-L® | Touch-up injection mean pain 30 min post-injection | 1.81 units on a scale | Standard Deviation 4.49 |
| Perlane-L® | Assessment of Injection Site Pain (Visual Analog Scale) of TEOSYAL® RHA Ultra Deep Versus Perlane-L® | Touch-up injection mean pain 30 min post-injection | 1.38 units on a scale | Standard Deviation 3.17 |
| Perlane-L® | Assessment of Injection Site Pain (Visual Analog Scale) of TEOSYAL® RHA Ultra Deep Versus Perlane-L® | Initial injection mean pain during injection | 23.85 units on a scale | Standard Deviation 21.35 |
| Perlane-L® | Assessment of Injection Site Pain (Visual Analog Scale) of TEOSYAL® RHA Ultra Deep Versus Perlane-L® | Touch-up injection mean pain during injection | 23.34 units on a scale | Standard Deviation 19.32 |
| Perlane-L® | Assessment of Injection Site Pain (Visual Analog Scale) of TEOSYAL® RHA Ultra Deep Versus Perlane-L® | Initial injection mean pain 5 min post-injection | 5.33 units on a scale | Standard Deviation 12.76 |
| Perlane-L® | Assessment of Injection Site Pain (Visual Analog Scale) of TEOSYAL® RHA Ultra Deep Versus Perlane-L® | Touch-up injection mean pain 15 min post-injection | 2.62 units on a scale | Standard Deviation 4.88 |
| Perlane-L® | Assessment of Injection Site Pain (Visual Analog Scale) of TEOSYAL® RHA Ultra Deep Versus Perlane-L® | Initial injection mean pain 15 min post-injection | 2.82 units on a scale | Standard Deviation 8.35 |
| Perlane-L® | Assessment of Injection Site Pain (Visual Analog Scale) of TEOSYAL® RHA Ultra Deep Versus Perlane-L® | Touch-up injection mean pain 5 min post-injection | 5.30 units on a scale | Standard Deviation 8.39 |
| Perlane-L® | Assessment of Injection Site Pain (Visual Analog Scale) of TEOSYAL® RHA Ultra Deep Versus Perlane-L® | Initial injection mean pain 30 min post-injection | 1.65 units on a scale | Standard Deviation 7.61 |
Secondary
Delta of the WSRS Score Between W2,4,12,24,36,52,64 and Baseline for TEOSYAL® RHA Ultra Deep Versus Perlane-L® for the Correction of Moderate to Severe NLFs Based on the Wrinkle Severity Rating Scale (WSRS) Score Assessed by the Treating Investigator (TI)
WSRS (Wrinkle Severity Rating Scale) is a validated 5-point scale with 1 being 'absent' and 5 being 'extreme'.
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 Ultra Deep | Delta of the WSRS Score Between W2,4,12,24,36,52,64 and Baseline for TEOSYAL® RHA Ultra Deep Versus Perlane-L® for the Correction of Moderate to Severe NLFs Based on the Wrinkle Severity Rating Scale (WSRS) Score Assessed by the Treating Investigator (TI) | W12 Delta from baseline | -1.70 units on a scale | Standard Deviation 0.78 |
| TEOSYAL® RHA Ultra Deep | Delta of the WSRS Score Between W2,4,12,24,36,52,64 and Baseline for TEOSYAL® RHA Ultra Deep Versus Perlane-L® for the Correction of Moderate to Severe NLFs Based on the Wrinkle Severity Rating Scale (WSRS) Score Assessed by the Treating Investigator (TI) | W36 Delta from baseline | -1.50 units on a scale | Standard Deviation 0.78 |
| TEOSYAL® RHA Ultra Deep | Delta of the WSRS Score Between W2,4,12,24,36,52,64 and Baseline for TEOSYAL® RHA Ultra Deep Versus Perlane-L® for the Correction of Moderate to Severe NLFs Based on the Wrinkle Severity Rating Scale (WSRS) Score Assessed by the Treating Investigator (TI) | W4 Delta from baseline | -1.85 units on a scale | Standard Deviation 0.58 |
| TEOSYAL® RHA Ultra Deep | Delta of the WSRS Score Between W2,4,12,24,36,52,64 and Baseline for TEOSYAL® RHA Ultra Deep Versus Perlane-L® for the Correction of Moderate to Severe NLFs Based on the Wrinkle Severity Rating Scale (WSRS) Score Assessed by the Treating Investigator (TI) | W52 Delta from baseline | -1.38 units on a scale | Standard Deviation 0.71 |
| TEOSYAL® RHA Ultra Deep | Delta of the WSRS Score Between W2,4,12,24,36,52,64 and Baseline for TEOSYAL® RHA Ultra Deep Versus Perlane-L® for the Correction of Moderate to Severe NLFs Based on the Wrinkle Severity Rating Scale (WSRS) Score Assessed by the Treating Investigator (TI) | W24 Delta from baseline | -1.45 units on a scale | Standard Deviation 0.76 |
| TEOSYAL® RHA Ultra Deep | Delta of the WSRS Score Between W2,4,12,24,36,52,64 and Baseline for TEOSYAL® RHA Ultra Deep Versus Perlane-L® for the Correction of Moderate to Severe NLFs Based on the Wrinkle Severity Rating Scale (WSRS) Score Assessed by the Treating Investigator (TI) | W64 Delta from baseline | -1.32 units on a scale | Standard Deviation 0.82 |
| TEOSYAL® RHA Ultra Deep | Delta of the WSRS Score Between W2,4,12,24,36,52,64 and Baseline for TEOSYAL® RHA Ultra Deep Versus Perlane-L® for the Correction of Moderate to Severe NLFs Based on the Wrinkle Severity Rating Scale (WSRS) Score Assessed by the Treating Investigator (TI) | W2 Delta from baseline | -1.77 units on a scale | Standard Deviation 0.6 |
| Perlane-L® | Delta of the WSRS Score Between W2,4,12,24,36,52,64 and Baseline for TEOSYAL® RHA Ultra Deep Versus Perlane-L® for the Correction of Moderate to Severe NLFs Based on the Wrinkle Severity Rating Scale (WSRS) Score Assessed by the Treating Investigator (TI) | W64 Delta from baseline | -1.03 units on a scale | Standard Deviation 0.77 |
| Perlane-L® | Delta of the WSRS Score Between W2,4,12,24,36,52,64 and Baseline for TEOSYAL® RHA Ultra Deep Versus Perlane-L® for the Correction of Moderate to Severe NLFs Based on the Wrinkle Severity Rating Scale (WSRS) Score Assessed by the Treating Investigator (TI) | W2 Delta from baseline | -1.51 units on a scale | Standard Deviation 0.68 |
| Perlane-L® | Delta of the WSRS Score Between W2,4,12,24,36,52,64 and Baseline for TEOSYAL® RHA Ultra Deep Versus Perlane-L® for the Correction of Moderate to Severe NLFs Based on the Wrinkle Severity Rating Scale (WSRS) Score Assessed by the Treating Investigator (TI) | W4 Delta from baseline | -1.60 units on a scale | Standard Deviation 0.63 |
| Perlane-L® | Delta of the WSRS Score Between W2,4,12,24,36,52,64 and Baseline for TEOSYAL® RHA Ultra Deep Versus Perlane-L® for the Correction of Moderate to Severe NLFs Based on the Wrinkle Severity Rating Scale (WSRS) Score Assessed by the Treating Investigator (TI) | W12 Delta from baseline | -1.34 units on a scale | Standard Deviation 0.74 |
| Perlane-L® | Delta of the WSRS Score Between W2,4,12,24,36,52,64 and Baseline for TEOSYAL® RHA Ultra Deep Versus Perlane-L® for the Correction of Moderate to Severe NLFs Based on the Wrinkle Severity Rating Scale (WSRS) Score Assessed by the Treating Investigator (TI) | W24 Delta from baseline | -1.05 units on a scale | Standard Deviation 0.76 |
| Perlane-L® | Delta of the WSRS Score Between W2,4,12,24,36,52,64 and Baseline for TEOSYAL® RHA Ultra Deep Versus Perlane-L® for the Correction of Moderate to Severe NLFs Based on the Wrinkle Severity Rating Scale (WSRS) Score Assessed by the Treating Investigator (TI) | W36 Delta from baseline | -1.16 units on a scale | Standard Deviation 0.73 |
| Perlane-L® | Delta of the WSRS Score Between W2,4,12,24,36,52,64 and Baseline for TEOSYAL® RHA Ultra Deep Versus Perlane-L® for the Correction of Moderate to Severe NLFs Based on the Wrinkle Severity Rating Scale (WSRS) Score Assessed by the Treating Investigator (TI) | W52 Delta from baseline | -0.99 units on a scale | Standard Deviation 0.67 |
Secondary
Delta of the WSRS Score Between W24,36,52 and 64 and Baseline for TEOSYAL® RHA Ultra Deep Versus Perlane-L® for the Correction of Moderate to Severe NLFs Based on the Wrinkle Severity Rating Scale (WSRS) Score Assessed by the Blinded Live Evaluator (BLE)
WSRS (Wrinkle Severity Rating Scale) is a validated 5-point scale with 1 being 'absent' and 5 being 'extreme'.
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 Ultra Deep | Delta of the WSRS Score Between W24,36,52 and 64 and Baseline for TEOSYAL® RHA Ultra Deep Versus Perlane-L® for the Correction of Moderate to Severe NLFs Based on the Wrinkle Severity Rating Scale (WSRS) Score Assessed by the Blinded Live Evaluator (BLE) | W24 Delta from baseline | -1.34 units on a scale | Standard Deviation 0.57 |
| TEOSYAL® RHA Ultra Deep | Delta of the WSRS Score Between W24,36,52 and 64 and Baseline for TEOSYAL® RHA Ultra Deep Versus Perlane-L® for the Correction of Moderate to Severe NLFs Based on the Wrinkle Severity Rating Scale (WSRS) Score Assessed by the Blinded Live Evaluator (BLE) | W36 Delta from baseline | -1.28 units on a scale | Standard Deviation 0.63 |
| TEOSYAL® RHA Ultra Deep | Delta of the WSRS Score Between W24,36,52 and 64 and Baseline for TEOSYAL® RHA Ultra Deep Versus Perlane-L® for the Correction of Moderate to Severe NLFs Based on the Wrinkle Severity Rating Scale (WSRS) Score Assessed by the Blinded Live Evaluator (BLE) | W52 Delta from baseline | -1.23 units on a scale | Standard Deviation 0.74 |
| TEOSYAL® RHA Ultra Deep | Delta of the WSRS Score Between W24,36,52 and 64 and Baseline for TEOSYAL® RHA Ultra Deep Versus Perlane-L® for the Correction of Moderate to Severe NLFs Based on the Wrinkle Severity Rating Scale (WSRS) Score Assessed by the Blinded Live Evaluator (BLE) | W64 Delta from baseline | -1.26 units on a scale | Standard Deviation 0.71 |
| Perlane-L® | Delta of the WSRS Score Between W24,36,52 and 64 and Baseline for TEOSYAL® RHA Ultra Deep Versus Perlane-L® for the Correction of Moderate to Severe NLFs Based on the Wrinkle Severity Rating Scale (WSRS) Score Assessed by the Blinded Live Evaluator (BLE) | W64 Delta from baseline | -1.11 units on a scale | Standard Deviation 0.71 |
| Perlane-L® | Delta of the WSRS Score Between W24,36,52 and 64 and Baseline for TEOSYAL® RHA Ultra Deep Versus Perlane-L® for the Correction of Moderate to Severe NLFs Based on the Wrinkle Severity Rating Scale (WSRS) Score Assessed by the Blinded Live Evaluator (BLE) | W24 Delta from baseline | -1.16 units on a scale | Standard Deviation 0.62 |
| Perlane-L® | Delta of the WSRS Score Between W24,36,52 and 64 and Baseline for TEOSYAL® RHA Ultra Deep Versus Perlane-L® for the Correction of Moderate to Severe NLFs Based on the Wrinkle Severity Rating Scale (WSRS) Score Assessed by the Blinded Live Evaluator (BLE) | W52 Delta from baseline | -1.05 units on a scale | Standard Deviation 0.67 |
| Perlane-L® | Delta of the WSRS Score Between W24,36,52 and 64 and Baseline for TEOSYAL® RHA Ultra Deep Versus Perlane-L® for the Correction of Moderate to Severe NLFs Based on the Wrinkle Severity Rating Scale (WSRS) Score Assessed by the Blinded Live Evaluator (BLE) | W36 Delta from baseline | -1.12 units on a scale | Standard Deviation 0.6 |
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. 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 Ultra Deep | Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either Much Improved or Improved) on GAI Scale. | W24 | 82 Participants |
| TEOSYAL® RHA Ultra Deep | Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either Much Improved or Improved) on GAI Scale. | W4 | 87 Participants |
| TEOSYAL® RHA Ultra Deep | Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either Much Improved or Improved) on GAI Scale. | W12 | 87 Participants |
| TEOSYAL® RHA Ultra Deep | Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either Much Improved or Improved) on GAI Scale. | W36 | 81 Participants |
| TEOSYAL® RHA Ultra Deep | Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either Much Improved or Improved) on GAI Scale. | W52 | 77 Participants |
| TEOSYAL® RHA Ultra Deep | Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either Much Improved or Improved) on GAI Scale. | W64 | 64 Participants |
| Perlane-L® | Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either Much Improved or Improved) on GAI Scale. | W52 | 73 Participants |
| Perlane-L® | Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either Much Improved or Improved) on GAI Scale. | W36 | 78 Participants |
| Perlane-L® | Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either Much Improved or Improved) on GAI Scale. | W4 | 88 Participants |
| Perlane-L® | Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either Much Improved or Improved) on GAI Scale. | W64 | 58 Participants |
| Perlane-L® | Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either Much Improved or Improved) on GAI Scale. | W12 | 85 Participants |
| Perlane-L® | Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either Much Improved or Improved) on GAI Scale. | W24 | 78 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 Ultra Deep | Number of Subjects Receiving Re-treatment | W24 | 6 Participants |
| TEOSYAL® RHA Ultra Deep | Number of Subjects Receiving Re-treatment | W36 | 3 Participants |
| TEOSYAL® RHA Ultra Deep | Number of Subjects Receiving Re-treatment | W52 | 12 Participants |
| TEOSYAL® RHA Ultra Deep | Number of Subjects Receiving Re-treatment | W64 | 49 Participants |
| Perlane-L® | Number of Subjects Receiving Re-treatment | W64 | 50 Participants |
| Perlane-L® | Number of Subjects Receiving Re-treatment | W24 | 6 Participants |
| Perlane-L® | Number of Subjects Receiving Re-treatment | W52 | 13 Participants |
| Perlane-L® | Number of Subjects Receiving Re-treatment | W36 | 6 Participants |
Secondary
Number of Subjects Receiving Touch-up Treatment
Time frame: Week 2
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TEOSYAL® RHA Ultra Deep | Number of Subjects Receiving Touch-up Treatment | 28 Participants |
| Perlane-L® | Number of Subjects Receiving Touch-up Treatment | 38 Participants |
Secondary
Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) 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. 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 Ultra Deep | Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) by the Blinded Live Evaluator (BLE) | W52 | 65 Participants |
| TEOSYAL® RHA Ultra Deep | Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) by the Blinded Live Evaluator (BLE) | W24 | 84 Participants |
| TEOSYAL® RHA Ultra Deep | Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) by the Blinded Live Evaluator (BLE) | W64 | 52 Participants |
| TEOSYAL® RHA Ultra Deep | Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) by the Blinded Live Evaluator (BLE) | W36 | 80 Participants |
| Perlane-L® | Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) by the Blinded Live Evaluator (BLE) | W64 | 47 Participants |
| Perlane-L® | Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) by the Blinded Live Evaluator (BLE) | W36 | 77 Participants |
| Perlane-L® | Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) by the Blinded Live Evaluator (BLE) | W52 | 62 Participants |
| Perlane-L® | Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) by the Blinded Live Evaluator (BLE) | W24 | 80 Participants |
Secondary
Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the Wrinkle Severity Rating Scale (WSRS) Compared to Baseline Assessed by the BLE
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 Ultra Deep | Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the Wrinkle Severity Rating Scale (WSRS) Compared to Baseline Assessed by the BLE | W24 | 97.7 percentage of responders |
| TEOSYAL® RHA Ultra Deep | Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the Wrinkle Severity Rating Scale (WSRS) Compared to Baseline Assessed by the BLE | W36 | 90.7 percentage of responders |
| TEOSYAL® RHA Ultra Deep | Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the Wrinkle Severity Rating Scale (WSRS) Compared to Baseline Assessed by the BLE | W52 | 87.0 percentage of responders |
| TEOSYAL® RHA Ultra Deep | Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the Wrinkle Severity Rating Scale (WSRS) Compared to Baseline Assessed by the BLE | W64 | 89.2 percentage of responders |
| Perlane-L® | Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the Wrinkle Severity Rating Scale (WSRS) Compared to Baseline Assessed by the BLE | W64 | 84.6 percentage of responders |
| Perlane-L® | Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the Wrinkle Severity Rating Scale (WSRS) Compared to Baseline Assessed by the BLE | W24 | 88.6 percentage of responders |
| Perlane-L® | Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the Wrinkle Severity Rating Scale (WSRS) Compared to Baseline Assessed by the BLE | W52 | 83.1 percentage of responders |
| Perlane-L® | Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the Wrinkle Severity Rating Scale (WSRS) Compared to Baseline Assessed by the BLE | W36 | 87.2 percentage of responders |
Secondary
Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the Wrinkle Severity Rating Scale (WSRS) Compared to Baseline Assessed by the TI
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 Ultra Deep | Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the Wrinkle Severity Rating Scale (WSRS) Compared to Baseline Assessed by the TI | W12 | 95.5 percentage of responders |
| TEOSYAL® RHA Ultra Deep | Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the Wrinkle Severity Rating Scale (WSRS) Compared to Baseline Assessed by the TI | W36 | 90.7 percentage of responders |
| TEOSYAL® RHA Ultra Deep | Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the Wrinkle Severity Rating Scale (WSRS) Compared to Baseline Assessed by the TI | W4 | 100.0 percentage of responders |
| TEOSYAL® RHA Ultra Deep | Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the Wrinkle Severity Rating Scale (WSRS) Compared to Baseline Assessed by the TI | W52 | 92.9 percentage of responders |
| TEOSYAL® RHA Ultra Deep | Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the Wrinkle Severity Rating Scale (WSRS) Compared to Baseline Assessed by the TI | W2 | 97.7 percentage of responders |
| TEOSYAL® RHA Ultra Deep | Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the Wrinkle Severity Rating Scale (WSRS) Compared to Baseline Assessed by the TI | W64 | 83.1 percentage of responders |
| TEOSYAL® RHA Ultra Deep | Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the Wrinkle Severity Rating Scale (WSRS) Compared to Baseline Assessed by the TI | W24 | 90.9 percentage of responders |
| Perlane-L® | Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the Wrinkle Severity Rating Scale (WSRS) Compared to Baseline Assessed by the TI | W64 | 76.1 percentage of responders |
| Perlane-L® | Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the Wrinkle Severity Rating Scale (WSRS) Compared to Baseline Assessed by the TI | W2 | 93.2 percentage of responders |
| Perlane-L® | Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the Wrinkle Severity Rating Scale (WSRS) Compared to Baseline Assessed by the TI | W12 | 88.6 percentage of responders |
| Perlane-L® | Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the Wrinkle Severity Rating Scale (WSRS) Compared to Baseline Assessed by the TI | W24 | 78.4 percentage of responders |
| Perlane-L® | Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the Wrinkle Severity Rating Scale (WSRS) Compared to Baseline Assessed by the TI | W36 | 83.7 percentage of responders |
| Perlane-L® | Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the Wrinkle Severity Rating Scale (WSRS) Compared to Baseline Assessed by the TI | W52 | 77.4 percentage of responders |
| Perlane-L® | Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the Wrinkle Severity Rating Scale (WSRS) Compared to Baseline Assessed by the TI | W4 | 97.7 percentage of responders |
Secondary
Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Ultra Deep Versus Perlane-L®
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: CTR are presented for the SAFT population (N=120) (see pre-assignment details) Number of patients for CTR after touch-up treatment are based on number of patients receiving Touch-up treatment (RHA-UD N=32/Perl N=47)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TEOSYAL® RHA Ultra Deep | Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Ultra Deep Versus Perlane-L® | Itching (initial treatment) | 30 Participants |
| TEOSYAL® RHA Ultra Deep | Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Ultra Deep Versus Perlane-L® | Bruising (initial treatment) | 70 Participants |
| TEOSYAL® RHA Ultra Deep | Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Ultra Deep Versus Perlane-L® | Bruising (Touch-up) | 17 Participants |
| TEOSYAL® RHA Ultra Deep | Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Ultra Deep Versus Perlane-L® | Discolouration (initial treatment) | 50 Participants |
| TEOSYAL® RHA Ultra Deep | Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Ultra Deep Versus Perlane-L® | Discolouration (Touch-up) | 9 Participants |
| TEOSYAL® RHA Ultra Deep | Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Ultra Deep Versus Perlane-L® | Firmness (initial treatment) | 91 Participants |
| TEOSYAL® RHA Ultra Deep | Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Ultra Deep Versus Perlane-L® | Firmness (Touch-up) | 24 Participants |
| TEOSYAL® RHA Ultra Deep | Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Ultra Deep Versus Perlane-L® | Itching (Touch-up) | 4 Participants |
| TEOSYAL® RHA Ultra Deep | Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Ultra Deep Versus Perlane-L® | Lumps/Bumps (initial treatment) | 81 Participants |
| TEOSYAL® RHA Ultra Deep | Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Ultra Deep Versus Perlane-L® | Lumps/Bumps (Touch-up) | 18 Participants |
| TEOSYAL® RHA Ultra Deep | Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Ultra Deep Versus Perlane-L® | Pain (initial treatment) | 66 Participants |
| TEOSYAL® RHA Ultra Deep | Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Ultra Deep Versus Perlane-L® | Pain (Touch-up) | 16 Participants |
| TEOSYAL® RHA Ultra Deep | Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Ultra Deep Versus Perlane-L® | Redness (initial treatment) | 84 Participants |
| TEOSYAL® RHA Ultra Deep | Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Ultra Deep Versus Perlane-L® | Redness (Touch-up) | 17 Participants |
| TEOSYAL® RHA Ultra Deep | Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Ultra Deep Versus Perlane-L® | Swelling (initial treatment) | 97 Participants |
| TEOSYAL® RHA Ultra Deep | Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Ultra Deep Versus Perlane-L® | Swelling (Touch-up) | 27 Participants |
| TEOSYAL® RHA Ultra Deep | Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Ultra Deep Versus Perlane-L® | Tenderness (initial treatment) | 90 Participants |
| TEOSYAL® RHA Ultra Deep | Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Ultra Deep Versus Perlane-L® | Tenderness (Touch-up) | 21 Participants |
| Perlane-L® | Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Ultra Deep Versus Perlane-L® | Swelling (Touch-up) | 38 Participants |
| Perlane-L® | Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Ultra Deep Versus Perlane-L® | Pain (initial treatment) | 87 Participants |
| Perlane-L® | Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Ultra Deep Versus Perlane-L® | Redness (initial treatment) | 91 Participants |
| Perlane-L® | Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Ultra Deep Versus Perlane-L® | Lumps/Bumps (initial treatment) | 90 Participants |
| Perlane-L® | Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Ultra Deep Versus Perlane-L® | Bruising (initial treatment) | 72 Participants |
| Perlane-L® | Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Ultra Deep Versus Perlane-L® | Redness (Touch-up) | 31 Participants |
| Perlane-L® | Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Ultra Deep Versus Perlane-L® | Bruising (Touch-up) | 22 Participants |
| Perlane-L® | Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Ultra Deep Versus Perlane-L® | Lumps/Bumps (Touch-up) | 30 Participants |
| Perlane-L® | Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Ultra Deep Versus Perlane-L® | Discolouration (initial treatment) | 56 Participants |
| Perlane-L® | Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Ultra Deep Versus Perlane-L® | Tenderness (Touch-up) | 35 Participants |
| Perlane-L® | Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Ultra Deep Versus Perlane-L® | Discolouration (Touch-up) | 12 Participants |
| Perlane-L® | Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Ultra Deep Versus Perlane-L® | Swelling (initial treatment) | 104 Participants |
| Perlane-L® | Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Ultra Deep Versus Perlane-L® | Firmness (initial treatment) | 93 Participants |
| Perlane-L® | Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Ultra Deep Versus Perlane-L® | Pain (Touch-up) | 31 Participants |
| Perlane-L® | Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Ultra Deep Versus Perlane-L® | Firmness (Touch-up) | 36 Participants |
| Perlane-L® | Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Ultra Deep Versus Perlane-L® | Itching (initial treatment) | 44 Participants |
| Perlane-L® | Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Ultra Deep Versus Perlane-L® | Tenderness (initial treatment) | 95 Participants |
| Perlane-L® | Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Ultra Deep Versus Perlane-L® | Itching (Touch-up) | 10 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 Ultra Deep | Subject's Perception of Treatment Effectiveness as Per the FACE-Q (NLF Domain) Questionnaire | W24 | 70.9 units on a scale | Standard Deviation 22.3 |
| TEOSYAL® RHA Ultra Deep | Subject's Perception of Treatment Effectiveness as Per the FACE-Q (NLF Domain) Questionnaire | W4 | 84.3 units on a scale | Standard Deviation 21 |
| TEOSYAL® RHA Ultra Deep | Subject's Perception of Treatment Effectiveness as Per the FACE-Q (NLF Domain) Questionnaire | W36 | 68.9 units on a scale | Standard Deviation 25 |
| TEOSYAL® RHA Ultra Deep | Subject's Perception of Treatment Effectiveness as Per the FACE-Q (NLF Domain) Questionnaire | W2 | 77.1 units on a scale | Standard Deviation 23.3 |
| TEOSYAL® RHA Ultra Deep | Subject's Perception of Treatment Effectiveness as Per the FACE-Q (NLF Domain) Questionnaire | W52 | 72.0 units on a scale | Standard Deviation 25.6 |
| TEOSYAL® RHA Ultra Deep | Subject's Perception of Treatment Effectiveness as Per the FACE-Q (NLF Domain) Questionnaire | W12 | 80.1 units on a scale | Standard Deviation 22.3 |
| TEOSYAL® RHA Ultra Deep | Subject's Perception of Treatment Effectiveness as Per the FACE-Q (NLF Domain) Questionnaire | W64 | 69.7 units on a scale | Standard Deviation 24 |
| TEOSYAL® RHA Ultra Deep | Subject's Perception of Treatment Effectiveness as Per the FACE-Q (NLF Domain) Questionnaire | pre-treatment | 24.7 units on a scale | Standard Deviation 19.2 |
| Perlane-L® | Subject's Perception of Treatment Effectiveness as Per the FACE-Q (NLF Domain) Questionnaire | W64 | 64.2 units on a scale | Standard Deviation 27.5 |
| Perlane-L® | Subject's Perception of Treatment Effectiveness as Per the FACE-Q (NLF Domain) Questionnaire | W2 | 74.0 units on a scale | Standard Deviation 23.9 |
| Perlane-L® | Subject's Perception of Treatment Effectiveness as Per the FACE-Q (NLF Domain) Questionnaire | W4 | 81.2 units on a scale | Standard Deviation 21 |
| Perlane-L® | Subject's Perception of Treatment Effectiveness as Per the FACE-Q (NLF Domain) Questionnaire | W12 | 74.4 units on a scale | Standard Deviation 25 |
| Perlane-L® | Subject's Perception of Treatment Effectiveness as Per the FACE-Q (NLF Domain) Questionnaire | W24 | 66.1 units on a scale | Standard Deviation 24.2 |
| Perlane-L® | Subject's Perception of Treatment Effectiveness as Per the FACE-Q (NLF Domain) Questionnaire | W36 | 61.5 units on a scale | Standard Deviation 25.5 |
| Perlane-L® | Subject's Perception of Treatment Effectiveness as Per the FACE-Q (NLF Domain) Questionnaire | W52 | 65.9 units on a scale | Standard Deviation 27.2 |
| Perlane-L® | Subject's Perception of Treatment Effectiveness as Per the FACE-Q (NLF Domain) Questionnaire | pre-treatment | 25.7 units on a scale | Standard Deviation 19.6 |
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 Ultra Deep | Subject's Satisfaction Score | W64 | 1.40 units on a scale | Standard Deviation 0.6 |
| TEOSYAL® RHA Ultra Deep | Subject's Satisfaction Score | W52 | 1.54 units on a scale | Standard Deviation 0.7 |
| TEOSYAL® RHA Ultra Deep | Subject's Satisfaction Score | W2 | 1.49 units on a scale | Standard Deviation 0.61 |
| TEOSYAL® RHA Ultra Deep | Subject's Satisfaction Score | W4 | 1.28 units on a scale | Standard Deviation 0.57 |
| TEOSYAL® RHA Ultra Deep | Subject's Satisfaction Score | W12 | 1.41 units on a scale | Standard Deviation 0.62 |
| TEOSYAL® RHA Ultra Deep | Subject's Satisfaction Score | W24 | 1.53 units on a scale | Standard Deviation 0.66 |
| TEOSYAL® RHA Ultra Deep | Subject's Satisfaction Score | W36 | 1.64 units on a scale | Standard Deviation 0.75 |
| Perlane-L® | Subject's Satisfaction Score | W64 | 1.67 units on a scale | Standard Deviation 0.9 |
| Perlane-L® | Subject's Satisfaction Score | W12 | 1.62 units on a scale | Standard Deviation 0.83 |
| Perlane-L® | Subject's Satisfaction Score | W52 | 1.77 units on a scale | Standard Deviation 0.87 |
| Perlane-L® | Subject's Satisfaction Score | W36 | 1.95 units on a scale | Standard Deviation 0.96 |
| Perlane-L® | Subject's Satisfaction Score | W2 | 1.63 units on a scale | Standard Deviation 0.88 |
| Perlane-L® | Subject's Satisfaction Score | W24 | 1.79 units on a scale | Standard Deviation 0.84 |
| Perlane-L® | Subject's Satisfaction Score | W4 | 1.31 units on a scale | Standard Deviation 0.58 |
Secondary
Volume to Obtain Optimal Cosmetic Result (Initial Treatment + Touch-up)
Time frame: Week 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TEOSYAL® RHA Ultra Deep | Volume to Obtain Optimal Cosmetic Result (Initial Treatment + Touch-up) | 1.79 mL | Standard Deviation 0.87 |
| Perlane-L® | Volume to Obtain Optimal Cosmetic Result (Initial Treatment + Touch-up) | 1.75 mL | Standard Deviation 0.9 |