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This is a randomized, controlled, double-blinded, within-subject (split-face), multicenter, prospective study to investigate whether RHA® Redensity with new anesthetic agent is non-inferior to RHA® Redensity with lidocaine in terms of injection site pain felt by the subject during injection.
At screening, the Treating Investigator (TI) evaluated subjects' perioral rhytid severity (using the Perioral Rhytid Severity Rating Scale; PR-SRS) to confirm eligibility and to establish a pre-treatment score for assessing aesthetic improvement.
At Visit 1, RHA® Redensity with new anesthetic agent was administered in a random sequence (first or second injection) and side of the mouth (left or right) and RHA® Redensity with lidocaine was administered to the other side. Study subjects and the TI injecting study devices were blinded.
Immediately after injection of an upper perioral quadrant, subjects rated the injection site pain experienced during injection using a 100 mm Visual Analog Scale (VAS). Injection site pain in each side of the mouth was also assessed at 15, 30, 45 and 60 minutes after injection of the upper quadrant.
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 were conducted.
Subjects who presented with an unresolved clinically significant device related AE at Visit 2 received a 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® Redensity with new anesthetic agent | Experimental | Split-face injection of RHA® Redensity with new anesthetic agent in the perioral rhytids on one side of the mouth and RHA® Redensity with lidocaine in the perioral rhytids in the other side of the mouth. Up to 3 mL injected per side. |
|
| RHA® Redensity with lidocaine | Experimental | Split-face injection of RHA® Redensity with lidocaine in the perioral rhytids on one side of the mouth and RHA® Redensity with new anesthetic agent in the perioral rhytids in the other side of the mouth. Up to 3 mL injected per side. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RHA® Redensity 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 15 mg/g and 0.3% w/w of new anesthetic agent in a physiologic buffer. |
| Measure | Description | Time Frame |
|---|---|---|
| Non-inferiority of RHA® Redensity With New Anesthetic Agent Versus RHA® Redensity With Lidocaine in Terms of Reducing Pain During Device Injection Into the Upper Perioral Rhytids. | Injection pain during injection was measured on the 100 mm Visual Analog Scale (VAS), as assessed by subjects immediately after injection of each upper perioral quadrant. 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® Redensity With New Anesthetic Agent Versus RHA® Redensity With Lidocaine in Term of Reducing Pain at 15, 30, 45 and 60 Minutes Post-injection in Each Side of the Mouth. | Injection pain was measured on the 100 mm Visual Analog Scale (VAS), as assessed by subjects in each side of the mouth. 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:
12. Exposure to any other investigational drug/device within 90 days of entering the study.
13. Clinically significant alcohol or drug abuse, or history of poor cooperation or unreliability.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California | Beverly Hills | California | 90120 | United States | ||
| Florida |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36129233 | Derived | Kaufman-Janette J, Joseph JH, Dayan SH, Smith S, Eaton L, Maffert P. Patient Comfort, Safety, and Effectiveness of Resilient Hyaluronic Acid Fillers Formulated With Different Local Anesthetics. Dermatol Surg. 2022 Oct 1;48(10):1065-1070. doi: 10.1097/DSS.0000000000003541. Epub 2022 Jul 13. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bilateral Treatment RHA® Redensity With New Anesthetic Agent Vs RHA® Redensity With Lidocaine | Split-face injection of RHA® Redensity With New Anesthetic Agent in the perioral rhytids on one side of the mouth and RHA® Redensity with lidocaine in the perioral rhytids on the other side of the mouth. RHA® Redensity With New Anesthetic Agent was administered in a random sequence (first or second injection) on one side of the mouth and RHA® Redensity with lidocaine was administered in the other side. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bilateral Treatment With RHA® Redensity With New Anesthetic Agent Vs RHA® Redensity With Lidocaine | Split-face injection of RHA® Redensity With New Anesthetic Agent in the perioral rhytids on one side of the mouth and RHA® Redensity with lidocaine in the perioral rhytids on the opposite side of the mouth. |
| 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® Redensity With New Anesthetic Agent Versus RHA® Redensity With Lidocaine in Terms of Reducing Pain During Device Injection Into the Upper Perioral Rhytids. | Injection pain during injection was measured on the 100 mm Visual Analog Scale (VAS), as assessed by subjects immediately after injection of each upper perioral quadrant. VAS is a 100 mm Visual Analog Scale with 0 meaning no pain and 100 meaning intolerable pain | There were 30 participants enrolled and treated, the participants received bilateral, split-face treatment into the upper perioral rhytids. | Posted | Mean | Standard Deviation | mm | Visit 1 - During Injection |
|
1 month (33 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® Redensity With New Anesthetic Agent | RHA® Redensity with new anesthetic agent 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 15 mg/g and 0.3% w/w of a new anesthetic agent in a physiologic buffer. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Osteomyelitis (toe on left foot) | Infections and infestations | MedDRA | Systematic Assessment | Osteomyelitis (toe on left foot) diagnosed in one patient, which underwent amputation of the affected toe - The event was unrelated to the study devices. SAE outcome was deemed to be resolved within 6 days. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chapped lips | Gastrointestinal 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 | Jan 17, 2022 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 19, 2020 | Jan 17, 2022 | SAP_003.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® Redensity with 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 15 mg/g and 0.3% w/w lidocaine in a physiologic buffer. |
|
| Visit 1 - 15, 30, 45 and 60 minutes post-injection |
| Change From Baseline of PR-SRS Score for RHA® Redensity With New Anesthetic Agent Vs RHA® Redensity With Lidocaine for the Correction of Perioral Rhytids as Assessed by the Treating Investigator (TI) | PR-SRS (Perioral Rhytids Severity Rating Scale) is a validated 4-grade scale with 0 being "Absent" and 3 being "Severe" | 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 Perioral Rhytids Severity Rating Scale (PR-SRS) 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 PR-SRS compared to Baseline | Visit 1 - Baseline (pre-injection), Visit 1 (post-injection), Visit 2 (Day 30) |
| Subject's Perception of Treatment Effectiveness as Per the FACE-Q (Perioral Rhytids 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 6 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 the area around your lips in mind, in the past week, how much have you been bothered by:", and will provide response. To calculate the FACE-Q, outcomes from all 6 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 will bewas assessed using the baseline photograph. Each side of the mouth were assessed independently. | Visit 1 (post-injection) 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 as follows: "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 (post-injection) and Visit 2 (Day 30) |
| Number of Both "Satisfied" or "Very Satisfied" Subjects 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 (post-injection) and Visit 2 (Day 30) |
| Number of Subjects With Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of RHA® Redensity With New Anesthetic Agent Versus RHA® Redensity With Lidocaine | The subjects will receive a diary booklet and instructions for recording his/her observations of the Common Treatment Responses to the study treatments within 30 days following the treatment. The diary will be 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 report "other" reactions if the subject experienced a sign/symptom that was not listed. | During 30 days after injection |
| Coral Gables |
| Florida |
| 33146 |
| United States |
| Chicago | 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 |
|
| OG001 | RHA® Redensity With New Anesthetic Agent | RHA® Redensity with new anesthetic agent 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 15 mg/g and 0.3% w/w of a new anesthetic agent in a physiologic buffer. |
|
|
|
| Secondary | Difference Between RHA® Redensity With New Anesthetic Agent Versus RHA® Redensity With Lidocaine in Term of Reducing Pain at 15, 30, 45 and 60 Minutes Post-injection in Each Side of the Mouth. | Injection pain was measured on the 100 mm Visual Analog Scale (VAS), as assessed by subjects in each side of the mouth. 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 From Baseline of PR-SRS Score for RHA® Redensity With New Anesthetic Agent Vs RHA® Redensity With Lidocaine for the Correction of Perioral Rhytids as Assessed by the Treating Investigator (TI) | PR-SRS (Perioral Rhytids Severity Rating Scale) is a validated 4-grade scale with 0 being "Absent" and 3 being "Severe" | 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 Perioral Rhytids Severity Rating Scale (PR-SRS) 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 PR-SRS compared to Baseline | 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 (Perioral Rhytids 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 6 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 the area around your lips in mind, in the past week, how much have you been bothered by:", and will provide response. To calculate the FACE-Q, outcomes from all 6 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 will bewas assessed using the baseline photograph. Each side of the mouth were assessed independently. | Posted | Count of Participants | Participants | Visit 1 (post-injection) 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 as follows: "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 (post-injection) and Visit 2 (Day 30) |
|
|
|
| Secondary | Number of Both "Satisfied" or "Very Satisfied" Subjects 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 | Count of Participants | Participants | Visit 1 (post-injection) 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® Redensity With New Anesthetic Agent Versus RHA® Redensity With Lidocaine | The subjects will receive a diary booklet and instructions for recording his/her observations of the Common Treatment Responses to the study treatments within 30 days following the treatment. The diary will be 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 report "other" reactions if the subject experienced a sign/symptom that was not listed. | Posted | Count of Participants | Participants | During 30 days after injection |
|
|
|
| 0 |
| 30 |
| 1 |
| 30 |
| 6 |
| 30 |
| EG001 | RHA® Redensity With Lidocaine | RHA® Redensity with lidocaine: 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 15 mg/g and 0.3% w/w lidocaine in a physiologic buffer. | 0 | 30 | 1 | 30 | 5 | 30 |
|
| Injection site induration | General disorders | MedDRA | Systematic Assessment |
|
| Injection site mass | General disorders | MedDRA | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA | Systematic Assessment |
|
| Osteomyelitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Needle track marks | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
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| 45 Min |
|
| 60 Min |
|
| Visit 2 - day 30 |
|
| Face-Q Change from Baseline to Day 30 |
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| Visit 2 (Day 30) |
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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 |
|
| Swelling |
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| Tenderness |
|
| Needle track marks |
|
| Injection Site Soreness |
|