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| Name | Class |
|---|---|
| ethica Clinical Research Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Left side TEOSYAL® RHA Ultra Deep, Right side Perlane-L® | Experimental | Split-face injection of TEOSYAL® RHA Ultra Deep into the left Naso Labial Folds (NLFs) and Perlane-L® into the right NLF (n=120). Up to 3.0 mL injected per NLF. Touch-up treatment provided at 2 weeks (up to 3.0 mL per NLF). |
|
| Left side Perlane-L®, Right side TEOSYAL® RHA Ultra Deep | Experimental | Split-face injection of Perlane-L® into the left Naso Labial Folds (NLFs) and TEOSYAL® RHA Ultra Deep into the right NLF (n=120). Up to 3.0 mL injected per NLF. Touch-up treatment provided at 2 weeks (up to 3.0 mL per NLF). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TEOSYAL® RHA Ultra Deep | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline and 24 weeks after last treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| United States | Beverly Hills | California | United States | |||
| United States |
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)
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)
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and 24 weeks after last treatment |
|
64 weeks or 68 weeks for patients receiving a re-treatment at W64
The TI assessed all AEs and recorded details of seriousness, severity, duration, and action taken with study device, and relationship to the study device.
Adverse Events are presented for the SAFT population (N=120) (see pre-assignment details)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TEOSYAL® RHA Ultra Deep | Injection of TEOSYAL® RHA Ultra Deep into one NLF |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | General disorders | Systematic Assessment | unrelated to the study device |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection Lumps/Bumps | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Project Manager | Teoxane | +41 (0) 22 344 96 36 | m.chenet@teoxane.com |
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|
| During 14 days after initial treatment (D0) and touch-up (2 weeks) |
| 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 | During Injection and 5, 15, 30 minutes post-injection |
| 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'. | Baseline and Weeks 24, 36, 52, 64 |
| 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'. | Baseline and Weeks 2, 4, 12, 24, 36, 52, 64 |
| 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 | Baseline and Weeks 24, 36, 52, 64 |
| 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 | Baseline and Weeks 2, 4, 12, 24, 36, 52, 64 |
| 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. | Weeks 24, 36, 52, 64 |
| 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. | Weeks 4, 12, 24, 36, 52, 64 |
| 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.
| Immediately post-injection, and weeks 2, 4, 12, 24, 36, 52, 64 |
| Subject's Satisfaction Score | Subjective 5-point scale with 1 being 'very satisfied' and 5 being 'very dissatisfied' | Weeks 2, 4, 12, 24, 36, 52, 64 |
| 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 |
| Bradenton |
| Florida |
| United States |
| United States | Chapel Hill | North Carolina | United States |
| United States | Philadelphia | Pennsylvania | United States |
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Fitzpatrick Skin Type | The Fitzpatrick scale is a numerical classification schema for human skin color. Type I - always burns, never tans (pale white; blond or red hair; blue eyes; freckles). Type II - usually burns, tans minimally (white; fair; blond or red hair; blue, green, or hazel eyes) Type III - sometimes mild burn, tans uniformly (cream white; fair with any hair or eye color) Type IV - burns minimally, always tans well (moderate brown) Type V - very rarely burns, tans very easily (dark brown) Type VI - Never burns, never tans (deeply pigmented dark brown to darkest brown) | Count of Participants | Participants |
|
|
|
|
| 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) | 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) | Posted | Count of Participants | Participants | During 14 days after initial treatment (D0) and touch-up (2 weeks) |
|
|
|
| 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 | 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 | Posted | Mean | Standard Deviation | units on a scale | During Injection and 5, 15, 30 minutes post-injection |
|
|
|
| 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'. | 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 | Baseline and Weeks 24, 36, 52, 64 |
|
|
|
| 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'. | 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 | Baseline and Weeks 2, 4, 12, 24, 36, 52, 64 |
|
|
|
| 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 | 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 |
|
|
|
| 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 | 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 |
|
|
|
| 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. | 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 |
|
|
|
| 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. | 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 |
|
|
|
| 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.
| 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 |
|
|
|
| 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 |
|
|
|
| Secondary | Volume to Obtain Optimal Cosmetic Result (Initial Treatment + Touch-up) | Posted | Mean | Standard Deviation | mL | Week 2 |
|
|
|
| Secondary | Number of Subjects Receiving Touch-up Treatment | Posted | Count of Participants | Participants | Week 2 |
|
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| 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 |
|
|
|
| 3 |
| 120 |
| 75 |
| 120 |
| EG001 | Perlane-L® | Injection of Perlane-L® into the controlateral NLF | 3 | 120 | 74 | 120 |
| Diverticulitis | General disorders | Systematic Assessment | unrelated to the study device |
|
| Lung Infection | Infections and infestations | Systematic Assessment | unrelated to the study device |
|
| Injection site firmness | General disorders | Systematic Assessment |
|
| Injection site swelling | General disorders | Systematic Assessment |
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| Tenderness | General disorders | Systematic Assessment |
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| Injection site discolouration | General disorders | Systematic Assessment |
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| Injection site erythema | General disorders | Systematic Assessment |
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| Injection site haematoma | General disorders | Systematic Assessment |
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| Injection site pain | General disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Acne | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Telangiectasia | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
Not provided
| Bruising (Touch-up) |
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| Discolouration (initial treatment) |
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| Discolouration (Touch-up) |
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| Firmness (initial treatment) |
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| Firmness (Touch-up) |
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| Itching (initial treatment) |
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| Itching (Touch-up) |
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| Lumps/Bumps (initial treatment) |
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| Lumps/Bumps (Touch-up) |
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| Pain (initial treatment) |
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| Pain (Touch-up) |
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| Redness (initial treatment) |
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| Redness (Touch-up) |
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| Swelling (initial treatment) |
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| Swelling (Touch-up) |
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| Tenderness (initial treatment) |
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| Tenderness (Touch-up) |
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| Initial injection mean pain 5 min post-injection |
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| Initial injection mean pain 15 min post-injection |
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| Initial injection mean pain 30 min post-injection |
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| Touch-up injection mean pain during injection |
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| Touch-up injection mean pain 5 min post-injection |
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| Touch-up injection mean pain 15 min post-injection |
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| Touch-up injection mean pain 30 min post-injection |
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| W36 Delta from baseline |
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| W52 Delta from baseline |
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| W64 Delta from baseline |
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| W4 Delta from baseline |
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| W12 Delta from baseline |
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| W24 Delta from baseline |
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| W36 Delta from baseline |
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| W52 Delta from baseline |
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| W64 Delta from baseline |
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| W36 |
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| W52 |
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| W64 |
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| W4 |
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| W12 |
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| W24 |
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| W36 |
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| W52 |
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| W64 |
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| W36 |
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| W52 |
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| W64 |
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| W12 |
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| W24 |
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| W36 |
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| W52 |
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| W64 |
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| W2 |
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| W4 |
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| W12 |
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| W24 |
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| W36 |
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| W52 |
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| W64 |
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| W4 |
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| W12 |
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| W24 |
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| W36 |
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| W52 |
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| W64 |
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| W36 |
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| W52 |
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| W64 |
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