An interventional study of RHA® Redensity with new anesthetic agent and RHA® Redensity with lidocaine in Aging and Pain, sponsored by Teoxane SA. Completed at 3 sites in United States. Open to participants aged 22 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-24.
Sponsored by Teoxane SA · Not applicable, Interventional, and Treatment
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.
Teoxane SA is the lead sponsor of 17 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
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.
Device: RHA® Redensity with new anesthetic agent
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.
Device: 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 of new anesthetic agent in a physiologic buffer.
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.
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
Time frame: Visit 1 - During Injection
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
Time frame: 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"
Time frame: 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
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: During 30 days after injection
| Milestone | Bilateral Treatment RHA® Redensity With New Anesthetic Agent Vs RHA® Redensity With Lidocaine |
|---|---|
| Started | 30 |
| Completed | 30 |
| Not completed | 0 |
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
| mm | RHA® Redensity With Lidocaine | RHA® Redensity With New Anesthetic Agent |
|---|---|---|
| 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. | 22.4 ± 23.21 | 25.0 ± 25.63 |
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
| mm | RHA® Redensity With Lidocaine | RHA® Redensity With New Anesthetic Agent |
|---|---|---|
| 15 Min | 6.3 ± 12.29 | 6.8 ± 13.72 |
| 30 Min | 1.0 ± 4.03 | 1.0 ± 4.19 |
| 45 Min | 0.3 ± 1.83 | 0.4 ± 2.37 |
| 60 Min | 0.0 ± 0.00 | 0.0 ± 0.00 |
PR-SRS (Perioral Rhytids Severity Rating Scale) is a validated 4-grade scale with 0 being "Absent" and 3 being "Severe"
| units on a scale | RHA® Redensity With Lidocaine | RHA® Redensity With New Anesthetic Agent |
|---|---|---|
| Visit 1 (Post-injection) | -1.5 ± 0.57 | -1.5 ± 0.63 |
| Visit 2 (Day 30) | -1.4 ± 0.57 | -1.4 ± 0.56 |
A responder corresponds to a subject with an intra-individual improvement of at least one grade on the PR-SRS compared to Baseline
| Participants | RHA® Redensity With Lidocaine | RHA® Redensity With New Anesthetic Agent |
|---|---|---|
| Visit 1 - post-injection — Responder | 29 | 28 |
| Visit 1 - post-injection — Not responder | 1 | 2 |
| Visit 2 - day 30 — Responder | 29 | 29 |
| Visit 2 - day 30 — Not responder | 1 | 1 |
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).
| score on a scale | RHA® Redensity With Lidocaine | RHA® Redensity With New Anesthetic Agent |
|---|---|---|
| Baseline Face-Q Score | 13.0 ± 19.07 | 12.5 ± 18.99 |
| Day 30 Face-Q Score | 73.9 ± 28.84 | 77.2 ± 25.78 |
| Face-Q Change from Baseline to Day 30 | 60.9 ± 36.10 | 64.7 ± 31.93 |
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.
| Participants | RHA® Redensity With Lidocaine | RHA® Redensity With New Anesthetic Agent |
|---|---|---|
| Visit 1 (post-injection) | 30 | 30 |
| Visit 2 (Day30) | 30 | 30 |
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.
| Participants | RHA® Redensity With Lidocaine | RHA® Redensity With New Anesthetic Agent |
|---|---|---|
| Visit 1 (post-injection) | 30 | 30 |
| Visit 2 (Day 30) | 30 | 30 |
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)
| Participants | RHA® Redensity With Lidocaine | RHA® Redensity With New Anesthetic Agent |
|---|---|---|
| Visit 1 (post-injection) — Satisfied (i.e., 1-Very Satisfied + 2-Satisfied) | 29 | 29 |
| Visit 1 (post-injection) — Not Satisfied (i.e., 3-Neither Satisfied nor dissatisfied + 4-Dissatisfied + 5-Very Dissatisfied) | 1 | 1 |
| Visit 2 (Day 30) — Satisfied (i.e., 1-Very Satisfied + 2-Satisfied) | 29 | 29 |
| Visit 2 (Day 30) — Not Satisfied (i.e., 3-Neither Satisfied nor dissatisfied + 4-Dissatisfied + 5-Very Dissatisfied) | 1 | 1 |
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.
| Participants | RHA® Redensity With Lidocaine | RHA® Redensity With New Anesthetic Agent |
|---|---|---|
| Bruising | 16 | 12 |
| Discoloration | 10 | 10 |
| Firmness | 19 | 14 |
| Itching | 2 | 4 |
| Lumps/Bumps | 17 | 15 |
| Pain | 4 | 3 |
| Redness | 15 | 16 |
| Swelling | 19 | 21 |
| Tenderness | 12 | 13 |
| Needle track marks | 1 | 1 |
| Injection Site Soreness | 1 | 1 |
Collected over 1 month (33 days, overall study duration). Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| RHA® Redensity With New Anesthetic Agent | 0/30 (0%) | 1/30 (3.3%) | 6/30 (20%) |
| RHA® Redensity With Lidocaine | 0/30 (0%) | 1/30 (3.3%) | 5/30 (16.7%) |
| Event | RHA® Redensity With New Anesthetic Agent | RHA® Redensity With Lidocaine |
|---|---|---|
| Osteomyelitis (toe on left foot)Infections and infestations | 1/30 | 1/30 |
| Event | RHA® Redensity With New Anesthetic Agent | RHA® Redensity With Lidocaine |
|---|---|---|
| Injection site indurationGeneral disorders | 2/30 | 2/30 |
| Chapped lipsGastrointestinal disorders | 1/30 | 1/30 |
| Injection site massGeneral disorders | 1/30 | 0/30 |
| Injection site painGeneral disorders | 1/30 | 1/30 |
| OsteomyelitisInfections and infestations | 1/30 | 1/30 |
| Needle track marksInjury, poisoning and procedural complications | 1/30 | 1/30 |
| Age, Continuous(years) | Bilateral Treatment With RHA® Redensity With New Anesthetic Agent Vs RHA® Redensity With Lidocaine |
|---|---|
| Mean | 64.3 ± 8.2 |
| Sex: Female, Male(Participants) | Bilateral Treatment With RHA® Redensity With New Anesthetic Agent Vs RHA® Redensity With Lidocaine |
|---|---|
| Female | 30 |
| Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | Bilateral Treatment With RHA® Redensity With New Anesthetic Agent Vs RHA® Redensity With Lidocaine |
|---|---|
| Hispanic or Latino | 11 |
| Not Hispanic or Latino | 19 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Bilateral Treatment With RHA® Redensity With New Anesthetic Agent Vs RHA® Redensity With Lidocaine |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 30 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Fitzpatrick Skin Type(Participants) | Bilateral Treatment With RHA® Redensity With New Anesthetic Agent Vs RHA® Redensity With Lidocaine |
|---|---|
| Types I to III as assessed by TI at screening | 23 |
| Types IV to VI as assessed by TI at screening | 7 |
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