An interventional study of RHA®4 with new anesthetic agent and RHA®4-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® 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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Exclusion Criteria:
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.
Device: 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. Up to 3 mL injected per side.
Device: RHA®4-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 23 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 23 mg/g and 0.3% w/w lidocaine in a physiologic buffer.
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.
Time frame: Visit 1 - During Injection
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
Time frame: 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"
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 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
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 (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).
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 was assessed using the baseline photograph. Each side of the face will be assessed independently.
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: During 30 days after injection
| Milestone | Split-face Study : Bilateral Treatment RHA® 4 With New Anesthetic Agent Vs RHA® 4-Lidocaine |
|---|---|
| Started | 30 |
| Completed | 30 |
| Not completed | 0 |
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.
| mm | RHA®4 With New Anesthetic Agent | RHA®4-Lidocaine |
|---|---|---|
| Non-inferiority of RHA® 4 With New Anesthetic Agent Versus RHA® 4-Lidocaine in Terms of Reducing Pain During Device Injection Into Nasolabial Folds. | 17.1 ± 18.38 | 16.3 ± 18.89 |
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
| mm | RHA®4 With New Anesthetic Agent | RHA®4-Lidocaine |
|---|---|---|
| 15 Min | 4.9 ± 12.33 | 5.1 ± 15.94 |
| 30 Min | 2.0 ± 5.66 | 3.1 ± 12.30 |
| 45 Min | 0.0 ± 0.00 | 2.1 ± 11.68 |
| 60 Min | 0.0 ± 0.00 | 1.9 ± 10.22 |
NLF-WSRS (Nasolabial Folds- Wrinkle Severity Rating Scale) is a validated 5-grade scale with 1 being "Absent" and 5 being "Extreme"
| units on a scale | RHA®4 With New Anesthetic Agent | RHA®4-Lidocaine |
|---|---|---|
| Visit 1 (post-injection) | -1.8 ± 0.57 | -1.8 ± 0.57 |
| Visit 2 (Day 30) | -1.9 ± 0.48 | -1.8 ± 0.63 |
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
| Participants | RHA®4 With New Anesthetic Agent | RHA®4-Lidocaine |
|---|---|---|
| Visit 1 (post-injection) — Responder | 30 | 30 |
| Visit 1 (post-injection) — Not Responder | 0 | 0 |
| Visit 2 (Day 30) — Responder | 30 | 29 |
| Visit 2 (Day 30) — Not Responder | 0 | 1 |
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).
| score on a scale | RHA®4 With New Anesthetic Agent | RHA®4-Lidocaine |
|---|---|---|
| Baseline Face-Q Score | 25.2 ± 21.12 | 24.3 ± 20.34 |
| Day 30 Face-Q Score | 89.0 ± 15.19 | 88.5 ± 16.16 |
| Face-Q Change from Baseline to Day 30 | 63.8 ± 24.69 | 64.2 ± 25.06 |
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.
| Participants | RHA®4 With New Anesthetic Agent | RHA®4-Lidocaine |
|---|---|---|
| Visit 1 (post-injection) | 30 | 30 |
| Visit 2 (Day 30) | 30 | 29 |
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.
| Participants | RHA®4 With New Anesthetic Agent | RHA®4-Lidocaine |
|---|---|---|
| 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®4 With New Anesthetic Agent | RHA®4-Lidocaine |
|---|---|---|
| Visit 1 (post-injection) : Satisfied | 30 | 30 |
| Visit 1 (post-inj): Not Satisfied | 0 | 0 |
| Visit 2 (Day 30) : Satisfied (i.e., 1-Very Satisfied + 2-Satisfied) | 29 | 29 |
| Visit 2 (Day 30) : Not Satisfied | 1 | 1 |
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.
| Participants | RHA®4 With New Anesthetic Agent | RHA®4-Lidocaine |
|---|---|---|
| Bruising | 19 | 21 |
| Discoloration | 11 | 12 |
| Firmness | 24 | 22 |
| Itching | 7 | 6 |
| Lumps/Bumps | 22 | 21 |
| Pain | 12 | 9 |
| Redness | 21 | 20 |
| Swelling | 21 | 23 |
| Tenderness | 24 | 24 |
| Paresthesia | 1 | 0 |
Collected over approximatly 1 month (35 days, overall study duration). Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| RHA®4 With New Anesthetic Agent | 0/30 (0%) | 0/30 (0%) | 5/30 (16.7%) |
| RHA®4-Lidocaine | 0/30 (0%) | 0/30 (0%) | 4/30 (13.3%) |
| Event | RHA®4 With New Anesthetic Agent | RHA®4-Lidocaine |
|---|---|---|
| Injection site indurationGeneral disorders | 3/30 | 4/30 |
| Injection site massGeneral disorders | 1/30 | 0/30 |
| Injection site pruritusGeneral disorders | 1/30 | 1/30 |
| Paresthesia oralNervous system disorders | 1/30 | 0/30 |
| Age, Continuous(years) | Split-face Study : Bilateral Treatment With RHA®4 With New Anesthetic Agent Vs RHA®4-Lidocaine |
|---|---|
| Mean | 57.0 ± 9.7 |
| Sex: Female, Male(Participants) | Split-face Study : Bilateral Treatment With RHA®4 With New Anesthetic Agent Vs RHA®4-Lidocaine |
|---|---|
| Female | 27 |
| Male | 3 |
| Ethnicity (NIH/OMB)(Participants) | Split-face Study : Bilateral Treatment With RHA®4 With New Anesthetic Agent Vs RHA®4-Lidocaine |
|---|---|
| Hispanic or Latino | 12 |
| Not Hispanic or Latino | 18 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Split-face Study : Bilateral Treatment With RHA®4 With New Anesthetic Agent Vs RHA®4-Lidocaine |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 3 |
| White | 27 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Fitzpatrick Skin Type(Participants) | Split-face Study : Bilateral Treatment With RHA®4 With New Anesthetic Agent Vs RHA®4-Lidocaine |
|---|---|
| Types I to III (as assessed by TI at screening) | 19 |
| Types IV to VI (as assessed by TI at screening) | 11 |
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