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This is a randomized, controlled, double-blinded, within-subject (split-face), multicenter, prospective study to investigate whether RHA® 4 with New Anesthetic Agent is non-inferior to RHA® 4 (with lidocaine) in terms of injection site pain felt by the subject during injection.
At screening, the Treating Investigator (TI) evaluated subjects' NLF severity (using the Wrinkle Severity Rating Scale; WSRS) to confirm eligibility and to establish a pre-treatment score for assessing aesthetic improvement.
At Visit 1, RHA® 4 With New Anesthetic Agent was administered in a random sequence (first or second injection) and side of the face (left or right) and RHA® 4 with lidocaine was administered to the other side. Study subjects and the TI injecting study devices were blinded.
Immediately after injection of each side, subjects rated injection site pain experienced during injection using a 100 mm Visual Analog Scale (VAS). Injection site pain in each side of the face was also assessed at 15, 30, 45 and 60 minutes post-injection.
Safety evaluation consisted of AE assessments, a 30-day CTR (Common Treatment Response) diary and a follow-up call performed by the study site at 72 hours after injection.
Subjects attended Visit 2 (30 days post-injection) where efficacy and safety assessments will be conducted. Subjects who present with an unresolved clinically significant device related AE at Visit 2 received the optional follow-up phone call no later than 30 days after Visit 2. If the clinically significant AE remained unresolved, the Investigator requested that the subject attended the optional in-clinic follow-up visit (i.e., Visit 3) within 5 working days. Follow-up of the clinically significant AE continued until the AE was resolved or the TI determines that additional follow-up was not necessary.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RHA®4 with new anesthetic agent | Experimental | Split-face injection of RHA®4 with new anesthetic agent in the nasolabial fold of one side of the face and RHA®4-Lidocaine in the nasolabial fold of opposite side of the face. Up to 3 mL injected per side. |
|
| RHA®4-Lidocaine | Experimental | Split-face injection of RHA®4 with new anesthetic agent in the nasolabial fold of one side of the face and RHA®4-Lidocaine in the nasolabial fold of opposite side of the face. Up to 3 mL injected per side. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RHA®4 with new anesthetic agent | Device | A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus zooepidemicus, formulated to a concentration of 23 mg/g and 0.3% w/w of new anesthetic agent in a physiologic buffer. |
| Measure | Description | Time Frame |
|---|---|---|
| Non-inferiority of RHA® 4 With New Anesthetic Agent Versus RHA® 4-Lidocaine in Terms of Reducing Pain During Device Injection Into Nasolabial Folds. | Injection pain during injection will be based on the 100 mm Visual Analog Scale (VAS), as assessed by subjects immediately after injection of each nasolabial fold. VAS is a 100 mm Visual Analog Scale with 0 meaning no pain and 100 meaning intolerable pain. | Visit 1 - During Injection |
| Measure | Description | Time Frame |
|---|---|---|
| Difference Between RHA® 4 With New Anesthetic Agent Versus RHA® 4-Lidocaine in Term of Reducing Pain at 15, 30, 45 and 60 Minutes Post-injection in Nasolabial Folds of Each Side of the Face. | Injection pain was measured on the 100 mm Visual Analog Scale (VAS), as assessed by subjects in nasolabial fold of each side of the face. VAS is a 100 mm Visual Analog Scale with 0 meaning no pain and 100 meaning intolerable pain |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California | Beverly Hills | California | 90210 | United States | ||
| Florida |
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| ID | Title | Description |
|---|---|---|
| FG000 | Split-face Study : Bilateral Treatment RHA® 4 With New Anesthetic Agent Vs RHA® 4-Lidocaine | Split-face injection of RHA® 4 with new anesthetic agent in the NLF on one side of the face and RHA® 4- Lidocaine in the NLF on the opposite side of the face. RHA® 4 with new anesthetic agent was administered in a random sequence (first or second injection) on one side and RHA®4-Lidocaine was administered in the side. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Split-face Study : Bilateral Treatment With RHA®4 With New Anesthetic Agent Vs RHA®4-Lidocaine | Split-face injection of RHA®4 with new anesthetic agent in the nasolabial folds on one side of the face and RHA®4-Lidocaine in the perioral rhytids on the opposite side of the face |
| 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 RHA® 4 With New Anesthetic Agent Versus RHA® 4-Lidocaine in Terms of Reducing Pain During Device Injection Into Nasolabial Folds. | Injection pain during injection will be based on the 100 mm Visual Analog Scale (VAS), as assessed by subjects immediately after injection of each nasolabial fold. VAS is a 100 mm Visual Analog Scale with 0 meaning no pain and 100 meaning intolerable pain. | Posted | Mean | Standard Deviation | mm | Visit 1 - During Injection |
|
approximatly 1 month (35 days, overall study duration)
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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 | RHA®4 With New Anesthetic Agent | Split-face injection of RHA®4 with new anesthetic agent in the nasolabial fold of one side of the face and RHA®4-Lidocaine in the nasolabial fold of opposite side of the face. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site induration | General disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Project Manager | TEOXANE SA | +41(0) 22 344 96 36 | clinical@teoxane.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 10, 2019 | Apr 29, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 19, 2020 | Apr 29, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Split-face design
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|
| RHA®4-Lidocaine | Device | A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus zooepidemicus, formulated to a concentration of 23 mg/g and 0.3% w/w lidocaine in a physiologic buffer. |
|
| Visit 1 - 15, 30, 45 and 60 minutes post-injection |
| Change in NLF WSRS Score Between Baseline and Day 30 as Assessed by the Treating Investigator | NLF-WSRS (Nasolabial Folds- Wrinkle Severity Rating Scale) is a validated 5-grade scale with 1 being "Absent" and 5 being "Extreme" | Visit 1 - Baseline (pre-injection), Visit 1 (post-injection), Visit 2 (Day 30) |
| Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade on the Nasolabial Folds Wrinkle Severity Rating Scale (NLF-WSRS) Compared to Baseline, as Assessed by the TI | A responder corresponds to a subject with an intra-individual improvement of at least one grade on the NLF WSRS compared to Baseline, as assessed by the TI | Visit 1 (Baseline, pre-injection), Visit 1 (post-injection), Visit 2 (Day 30) |
| Subject's Perception of Treatment Effectiveness as Per the FACE-Q (Nasolabial Folds 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 will be instructed as follows: "These questions ask about how you look right now. For each question, circle only one answer. 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 will provide response. To calculate the FACE-Q, outcomes from all 5 questions were pooled, data were transformed so that higher scores reflected a superior outcome, and adapted to a scale of 100 units (i.e. lowest score = 0, highest score = 100). | Visit 1 (Baseline) and Visit 2 (Day 30) |
| Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) by the Treating Investigator (TI) | 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 will be assessed independently. | Visit 1 (just after receiving treatment) and Visit 2 (Day 30) |
| Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either "Much Improved" or "Improved") on GAI Scale According to Subject's Self-assessment | 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 were 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. | Visit 1 (just after receiving treatment) and Visit 2 (Day 30) |
| Number of Subjects "Satisfied" or "Very Satisfied" With Study Treatment Using the Subject's Satisfaction Scale | The Subject Satisfaction Scale is a subjective, balanced, 5-point scale assessing subject satisfaction with study treatment. Possible scores range from with 1 (very satisfied) to 5 (very dissatisfied). Proportion of subjects who were Satisfied (i.e., 1-Very Satisfied + 2-Satisfied) was compared to the proportion of subjects who were Not Satisfied (i.e., 3-Neither Satisfied nor dissatisfied + 4-Dissatisfied + 5-Very Dissatisfied) | Visit 1 (just after receiving treatment) and Visit 2 (Day 30) |
| Number of Subjects With Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of RHA® 4 With New Anesthetic Agent Versus RHA® 4-Lidocaine | The subjects received a diary booklet and instructions for recording their observations of the Common Treatment Responses to the study treatments during 30 days following the injection. The diary were discussed during follow-up phone call and visit. Subjects were instructed to 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 30-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. | During 30 days after injection |
| Coral Gables |
| Florida |
| 33146 |
| United States |
| Illinois | Chicago | Illinois | 60611 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | 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 |
|
Split-face injection of RHA®4 with new anesthetic agent in the nasolabial fold of one side of the face and RHA®4-Lidocaine in the nasolabial fold of opposite side of the face.
|
|
|
| Secondary | Difference Between RHA® 4 With New Anesthetic Agent Versus RHA® 4-Lidocaine in Term of Reducing Pain at 15, 30, 45 and 60 Minutes Post-injection in Nasolabial Folds of Each Side of the Face. | Injection pain was measured on the 100 mm Visual Analog Scale (VAS), as assessed by subjects in nasolabial fold of each side of the face. VAS is a 100 mm Visual Analog Scale with 0 meaning no pain and 100 meaning intolerable pain | Posted | Mean | Standard Deviation | mm | Visit 1 - 15, 30, 45 and 60 minutes post-injection |
|
|
|
| Secondary | Change in NLF WSRS Score Between Baseline and Day 30 as Assessed by the Treating Investigator | NLF-WSRS (Nasolabial Folds- Wrinkle Severity Rating Scale) is a validated 5-grade scale with 1 being "Absent" and 5 being "Extreme" | Posted | Mean | Standard Deviation | units on a scale | Visit 1 - Baseline (pre-injection), Visit 1 (post-injection), Visit 2 (Day 30) |
|
|
|
| Secondary | Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade on the Nasolabial Folds Wrinkle Severity Rating Scale (NLF-WSRS) Compared to Baseline, as Assessed by the TI | A responder corresponds to a subject with an intra-individual improvement of at least one grade on the NLF WSRS compared to Baseline, as assessed by the TI | Posted | Count of Participants | Participants | Visit 1 (Baseline, pre-injection), Visit 1 (post-injection), Visit 2 (Day 30) |
|
|
|
| Secondary | Subject's Perception of Treatment Effectiveness as Per the FACE-Q (Nasolabial Folds 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 will be instructed as follows: "These questions ask about how you look right now. For each question, circle only one answer. 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 will provide response. To calculate the FACE-Q, outcomes from all 5 questions were pooled, data were transformed so that higher scores reflected a superior outcome, and adapted to a scale of 100 units (i.e. lowest score = 0, highest score = 100). | Posted | Mean | Standard Deviation | score on a scale | Visit 1 (Baseline) and Visit 2 (Day 30) |
|
|
|
| Secondary | Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) by the Treating Investigator (TI) | 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 will be assessed independently. | Posted | Count of Participants | Participants | Visit 1 (just after receiving treatment) and Visit 2 (Day 30) |
|
|
|
| Secondary | Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either "Much Improved" or "Improved") on GAI Scale According to Subject's Self-assessment | 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 were 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. | Posted | Count of Participants | Participants | Visit 1 (just after receiving treatment) and Visit 2 (Day 30) |
|
|
|
| Secondary | Number of Subjects "Satisfied" or "Very Satisfied" With Study Treatment Using the Subject's Satisfaction Scale | The Subject Satisfaction Scale is a subjective, balanced, 5-point scale assessing subject satisfaction with study treatment. Possible scores range from with 1 (very satisfied) to 5 (very dissatisfied). Proportion of subjects who were Satisfied (i.e., 1-Very Satisfied + 2-Satisfied) was compared to the proportion of subjects who were Not Satisfied (i.e., 3-Neither Satisfied nor dissatisfied + 4-Dissatisfied + 5-Very Dissatisfied) | Posted | Number | participants | Visit 1 (just after receiving treatment) and Visit 2 (Day 30) |
|
|
|
| Secondary | Number of Subjects With Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of RHA® 4 With New Anesthetic Agent Versus RHA® 4-Lidocaine | The subjects received a diary booklet and instructions for recording their observations of the Common Treatment Responses to the study treatments during 30 days following the injection. The diary were discussed during follow-up phone call and visit. Subjects were instructed to 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 30-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. | Posted | Count of Participants | Participants | During 30 days after injection |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 5 |
| 30 |
| EG001 | RHA®4-Lidocaine | Split-face injection of RHA®4 with new anesthetic agent in the nasolabial fold of one side of the face and RHA®4-Lidocaine in the nasolabial fold of opposite side of the face. | 0 | 30 | 0 | 30 | 4 | 30 |
| Injection site mass | General disorders | MedDRA | Systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA | Systematic Assessment |
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| Paresthesia oral | Nervous system disorders | MedDRA | Systematic Assessment |
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| 45 Min |
|
| 60 Min |
|
| Visit 2 (Day 30) |
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| Face-Q Change from Baseline to Day 30 |
|
| Visit 2 (Day 30) : Satisfied (i.e., 1-Very Satisfied + 2-Satisfied) |
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| Visit 2 (Day 30) : Not Satisfied |
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| Firmness |
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| Itching |
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| Lumps/Bumps |
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| Pain |
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| Redness |
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| Swelling |
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| Tenderness |
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| Paresthesia |
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