Aging, Pain
Conditions
Keywords
Hyaluronic Acid, Anesthetic, Lidocaine, Nasolabial Folds
Brief summary
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.
Interventions
DEVICERHA®4 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 23 mg/g and 0.3% w/w of new anesthetic agent in a physiologic buffer.
DEVICERHA®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 lidocaine in a physiologic buffer.
Sponsors
Teoxane SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
Split-face design
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Outpatient, male or female of any race, 22 years of age or older. Female subjects of childbearing potential must have a negative UPT at Visit 1 and practice a reliable method of contraception throughout the study. 2. Moderate to severe bilateral nasolabial folds (grade 3 or 4 on the five-point WSRS). 3. Nasolabial folds of the same WSRS grade on the left and right sides of the face. 4. Able to follow study instructions and complete all required visits. 5. Sign the IRB-approved ICF, Photographic Release Form, the Authorization for Use and release of Health and Research Study Information (HIPAA) form, and if applicable the California Experimental Research Subject's Bill of Rights prior to any study-related procedures being performed.
Exclusion criteria
1. Female subjects who are pregnant, breast-feeding, or of childbearing potential and not practicing reliable birth control. 2. Known hypersensitivity or previous allergic reaction to any component of the study devices. 3. Use of a prohibited treatment/procedure within time periods defined in the protocol 4. Known sensitivity to local anesthetics of the amide type, history of multiple severe allergies, or history of anaphylactic shock. 5. History of active chronic debilitating systemic disease that, in the opinion of the investigator, would make the subject a poor candidate in the study. 6. History of connective tissue disease. 7. Malignancy (excluding non-melanoma skin cancer) within the past 5 years. 8. History of skin cancer in the treatment area. 9. Clinically active disease or infection in the NLF area. 10. Medical or psychiatric conditions that may increase the risk associated with study participation or may interfere with the interpretation of study results or compliance of the subject and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study. 11. Clinically significant alcohol or drug abuse, or history of poor cooperation or unreliability. 12. Exposure to any other investigational drug/device within 90 days of entering the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Non-inferiority of RHA® 4 With New Anesthetic Agent Versus RHA® 4-Lidocaine in Terms of Reducing Pain During Device Injection Into Nasolabial Folds. | Visit 1 - During Injection | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in NLF WSRS Score Between Baseline and Day 30 as Assessed by the Treating Investigator | Visit 1 - Baseline (pre-injection), Visit 1 (post-injection), Visit 2 (Day 30) | NLF-WSRS (Nasolabial Folds- Wrinkle Severity Rating Scale) is a validated 5-grade scale with 1 being Absent and 5 being Extreme |
| 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 | Visit 1 (Baseline, pre-injection), Visit 1 (post-injection), Visit 2 (Day 30) | 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 |
| 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. | Visit 1 (Baseline) and Visit 2 (Day 30) | 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). |
| 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. | Visit 1 - 15, 30, 45 and 60 minutes post-injection | 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 |
| Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either Much Improved or Improved) on GAI Scale According to Subject's Self-assessment | Visit 1 (just after receiving treatment) and Visit 2 (Day 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: 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. |
| Number of Subjects Satisfied or Very Satisfied With Study Treatment Using the Subject's Satisfaction Scale | Visit 1 (just after receiving treatment) and Visit 2 (Day 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) |
| 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 | During 30 days after injection | 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. |
| Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) by the Treating Investigator (TI) | Visit 1 (just after receiving treatment) and Visit 2 (Day 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. Each side of the face will be assessed independently. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Split-face Study : Bilateral Treatment With RHA®4 With New Anesthetic Agent Vs RHA®4-Lidocaine |
|---|---|
| Age, Continuous | 57.0 years STANDARD_DEVIATION 9.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Fitzpatrick Skin Type Types I to III (as assessed by TI at screening) | 19 Participants |
| Fitzpatrick Skin Type Types IV to VI (as assessed by TI at screening) | 11 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 27 Participants |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 5 / 30 | 4 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
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.
Time frame: Visit 1 - During Injection
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RHA®4 With New Anesthetic Agent | 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 mm | Standard Deviation 18.38 |
| 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. | 16.3 mm | Standard Deviation 18.89 |
p-value: <0.0001t-test, 1 sided
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
Time frame: Visit 1 - Baseline (pre-injection), Visit 1 (post-injection), Visit 2 (Day 30)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RHA®4 With New Anesthetic Agent | Change in NLF WSRS Score Between Baseline and Day 30 as Assessed by the Treating Investigator | Visit 2 (Day 30) | -1.9 units on a scale | Standard Deviation 0.48 |
| RHA®4 With New Anesthetic Agent | Change in NLF WSRS Score Between Baseline and Day 30 as Assessed by the Treating Investigator | Visit 1 (post-injection) | -1.8 units on a scale | Standard Deviation 0.57 |
| RHA®4-Lidocaine | Change in NLF WSRS Score Between Baseline and Day 30 as Assessed by the Treating Investigator | Visit 1 (post-injection) | -1.8 units on a scale | Standard Deviation 0.57 |
| RHA®4-Lidocaine | Change in NLF WSRS Score Between Baseline and Day 30 as Assessed by the Treating Investigator | Visit 2 (Day 30) | -1.8 units on a scale | Standard Deviation 0.63 |
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
Time frame: Visit 1 - 15, 30, 45 and 60 minutes post-injection
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RHA®4 With New Anesthetic Agent | 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. | 15 Min | 4.9 mm | Standard Deviation 12.33 |
| RHA®4 With New Anesthetic Agent | 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. | 30 Min | 2.0 mm | Standard Deviation 5.66 |
| RHA®4 With New Anesthetic Agent | 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. | 45 Min | 0.0 mm | Standard Deviation 0 |
| RHA®4 With New Anesthetic Agent | 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. | 60 Min | 0.0 mm | Standard Deviation 0 |
| RHA®4-Lidocaine | 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. | 60 Min | 1.9 mm | Standard Deviation 10.22 |
| RHA®4-Lidocaine | 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. | 15 Min | 5.1 mm | Standard Deviation 15.94 |
| RHA®4-Lidocaine | 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. | 45 Min | 2.1 mm | Standard Deviation 11.68 |
| RHA®4-Lidocaine | 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. | 30 Min | 3.1 mm | Standard Deviation 12.3 |
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.
Time frame: Visit 1 (just after receiving treatment) and Visit 2 (Day 30)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RHA®4 With New Anesthetic Agent | Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either Much Improved or Improved) on GAI Scale According to Subject's Self-assessment | Visit 1 (post-injection) | 30 Participants |
| RHA®4 With New Anesthetic Agent | Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either Much Improved or Improved) on GAI Scale According to Subject's Self-assessment | Visit 2 (Day 30) | 30 Participants |
| RHA®4-Lidocaine | Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either Much Improved or Improved) on GAI Scale According to Subject's Self-assessment | Visit 1 (post-injection) | 30 Participants |
| RHA®4-Lidocaine | Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either Much Improved or Improved) on GAI Scale According to Subject's Self-assessment | Visit 2 (Day 30) | 30 Participants |
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)
Time frame: Visit 1 (just after receiving treatment) and Visit 2 (Day 30)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RHA®4 With New Anesthetic Agent | Number of Subjects Satisfied or Very Satisfied With Study Treatment Using the Subject's Satisfaction Scale | Visit 1 (post-injection) : Satisfied | 30 participants |
| RHA®4 With New Anesthetic Agent | Number of Subjects Satisfied or Very Satisfied With Study Treatment Using the Subject's Satisfaction Scale | Visit 1 (post-inj): Not Satisfied | 0 participants |
| RHA®4 With New Anesthetic Agent | Number of Subjects Satisfied or Very Satisfied With Study Treatment Using the Subject's Satisfaction Scale | Visit 2 (Day 30) : Satisfied (i.e., 1-Very Satisfied + 2-Satisfied) | 29 participants |
| RHA®4 With New Anesthetic Agent | Number of Subjects Satisfied or Very Satisfied With Study Treatment Using the Subject's Satisfaction Scale | Visit 2 (Day 30) : Not Satisfied | 1 participants |
| RHA®4-Lidocaine | Number of Subjects Satisfied or Very Satisfied With Study Treatment Using the Subject's Satisfaction Scale | Visit 2 (Day 30) : Not Satisfied | 1 participants |
| RHA®4-Lidocaine | Number of Subjects Satisfied or Very Satisfied With Study Treatment Using the Subject's Satisfaction Scale | Visit 1 (post-injection) : Satisfied | 30 participants |
| RHA®4-Lidocaine | Number of Subjects Satisfied or Very Satisfied With Study Treatment Using the Subject's Satisfaction Scale | Visit 2 (Day 30) : Satisfied (i.e., 1-Very Satisfied + 2-Satisfied) | 29 participants |
| RHA®4-Lidocaine | Number of Subjects Satisfied or Very Satisfied With Study Treatment Using the Subject's Satisfaction Scale | Visit 1 (post-inj): Not Satisfied | 0 participants |
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.
Time frame: Visit 1 (just after receiving treatment) and Visit 2 (Day 30)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RHA®4 With New Anesthetic Agent | Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) by the Treating Investigator (TI) | Visit 1 (post-injection) | 30 Participants |
| RHA®4 With New Anesthetic Agent | Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) by the Treating Investigator (TI) | Visit 2 (Day 30) | 30 Participants |
| RHA®4-Lidocaine | Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) by the Treating Investigator (TI) | Visit 1 (post-injection) | 30 Participants |
| RHA®4-Lidocaine | Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) by the Treating Investigator (TI) | Visit 2 (Day 30) | 29 Participants |
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.
Time frame: During 30 days after injection
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RHA®4 With New Anesthetic Agent | 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 | Bruising | 19 Participants |
| RHA®4 With New Anesthetic Agent | 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 | Discoloration | 11 Participants |
| RHA®4 With New Anesthetic Agent | 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 | Firmness | 24 Participants |
| RHA®4 With New Anesthetic Agent | 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 | Itching | 7 Participants |
| RHA®4 With New Anesthetic Agent | 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 | Lumps/Bumps | 22 Participants |
| RHA®4 With New Anesthetic Agent | 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 | Pain | 12 Participants |
| RHA®4 With New Anesthetic Agent | 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 | Redness | 21 Participants |
| RHA®4 With New Anesthetic Agent | 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 | Swelling | 21 Participants |
| RHA®4 With New Anesthetic Agent | 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 | Tenderness | 24 Participants |
| RHA®4 With New Anesthetic Agent | 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 | Paresthesia | 1 Participants |
| RHA®4-Lidocaine | 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 | Swelling | 23 Participants |
| RHA®4-Lidocaine | 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 | Bruising | 21 Participants |
| RHA®4-Lidocaine | 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 | Pain | 9 Participants |
| RHA®4-Lidocaine | 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 | Discoloration | 12 Participants |
| RHA®4-Lidocaine | 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 | Paresthesia | 0 Participants |
| RHA®4-Lidocaine | 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 | Firmness | 22 Participants |
| RHA®4-Lidocaine | 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 | Redness | 20 Participants |
| RHA®4-Lidocaine | 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 | Itching | 6 Participants |
| RHA®4-Lidocaine | 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 | Tenderness | 24 Participants |
| RHA®4-Lidocaine | 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 | Lumps/Bumps | 21 Participants |
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
Time frame: Visit 1 (Baseline, pre-injection), Visit 1 (post-injection), Visit 2 (Day 30)
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| RHA®4 With New Anesthetic Agent | 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 | Visit 1 (post-injection) | Responder | 30 Participants |
| RHA®4 With New Anesthetic Agent | 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 | Visit 1 (post-injection) | Not Responder | 0 Participants |
| RHA®4 With New Anesthetic Agent | 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 | Visit 2 (Day 30) | Responder | 30 Participants |
| RHA®4 With New Anesthetic Agent | 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 | Visit 2 (Day 30) | Not Responder | 0 Participants |
| RHA®4-Lidocaine | 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 | Visit 2 (Day 30) | Not Responder | 1 Participants |
| RHA®4-Lidocaine | 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 | Visit 1 (post-injection) | Responder | 30 Participants |
| RHA®4-Lidocaine | 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 | Visit 2 (Day 30) | Responder | 29 Participants |
| RHA®4-Lidocaine | 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 | Visit 1 (post-injection) | Not Responder | 0 Participants |
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).
Time frame: Visit 1 (Baseline) and Visit 2 (Day 30)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RHA®4 With New Anesthetic Agent | 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. | Baseline Face-Q Score | 25.2 score on a scale | Standard Deviation 21.12 |
| RHA®4 With New Anesthetic Agent | 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. | Day 30 Face-Q Score | 89.0 score on a scale | Standard Deviation 15.19 |
| RHA®4 With New Anesthetic Agent | 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 Change from Baseline to Day 30 | 63.8 score on a scale | Standard Deviation 24.69 |
| RHA®4-Lidocaine | 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. | Baseline Face-Q Score | 24.3 score on a scale | Standard Deviation 20.34 |
| RHA®4-Lidocaine | 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. | Day 30 Face-Q Score | 88.5 score on a scale | Standard Deviation 16.16 |
| RHA®4-Lidocaine | 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 Change from Baseline to Day 30 | 64.2 score on a scale | Standard Deviation 25.06 |