Trial Outcomes & Findings for RHA® Redensity With New Anesthetic Agent - Perioral Rhytids (NCT NCT04069585)

NCT ID: NCT04069585

Last Updated: 2022-01-24

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 30 participants
• Primary outcome timeframe: Visit 1 - During Injection
• Results posted on: 2022-01-24

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

RHA® Redensity With New Anesthetic Agent - Perioral Rhytids

Baseline characteristics by cohort

Measure	Bilateral Treatment With RHA® Redensity With New Anesthetic Agent Vs RHA® Redensity With Lidocaine n=30 Participants 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.
Age, Continuous	64.3 years STANDARD_DEVIATION 8.2 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	30 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Fitzpatrick Skin Type Types I to III as assessed by TI at screening	23 Participants n=5 Participants
Fitzpatrick Skin Type Types IV to VI as assessed by TI at screening	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: Visit 1 - During Injection

Population: There were 30 participants enrolled and treated, the participants received bilateral, split-face treatment 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

Outcome measures

Measure	RHA® Redensity With New Anesthetic Agent n=30 Participants 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.	RHA® Redensity With Lidocaine n=30 Participants 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.
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.	25.0 mm Standard Deviation 25.63	22.4 mm Standard Deviation 23.21

SECONDARY outcome

Timeframe: 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 each side of the mouth.

VAS is a 100 mm Visual Analog Scale with 0 meaning no pain and 100 meaning intolerable pain

Outcome measures

Measure	RHA® Redensity With New Anesthetic Agent n=30 Participants 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.	RHA® Redensity With Lidocaine n=30 Participants 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.
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. 15 Min	6.8 mm Standard Deviation 13.72	6.3 mm Standard Deviation 12.29
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. 30 Min	1.0 mm Standard Deviation 4.19	1.0 mm Standard Deviation 4.03
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. 45 Min	0.4 mm Standard Deviation 2.37	0.3 mm Standard Deviation 1.83
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. 60 Min	0.0 mm Standard Deviation 0.00	0.0 mm Standard Deviation 0.00

SECONDARY outcome

Timeframe: Visit 1 (Baseline, pre-injection) - Visit 1 (post-injection), Visit 2 (Day 30)

PR-SRS (Perioral Rhytids Severity Rating Scale) is a validated 4-grade scale with 0 being "Absent" and 3 being "Severe"

Outcome measures

Measure	RHA® Redensity With New Anesthetic Agent n=30 Participants 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.	RHA® Redensity With Lidocaine n=30 Participants 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.
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) Visit 1 (Post-injection)	-1.5 units on a scale Standard Deviation 0.63	-1.5 units on a scale Standard Deviation 0.57
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) Visit 2 (Day 30)	-1.4 units on a scale Standard Deviation 0.56	-1.4 units on a scale Standard Deviation 0.57

SECONDARY outcome

Timeframe: 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 PR-SRS compared to Baseline

Outcome measures

Measure	RHA® Redensity With New Anesthetic Agent n=30 Participants 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.	RHA® Redensity With Lidocaine n=30 Participants 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.
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 Visit 1 - post-injection · Responder	28 Participants	29 Participants
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 Visit 1 - post-injection · Not responder	2 Participants	1 Participants
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 Visit 2 - day 30 · Responder	29 Participants	29 Participants
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 Visit 2 - day 30 · Not responder	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Visit 1 (Baseline) and Visit 2 (Day 30)

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).

Outcome measures

Measure	RHA® Redensity With New Anesthetic Agent n=30 Participants 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.	RHA® Redensity With Lidocaine n=30 Participants 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.
Subject's Perception of Treatment Effectiveness as Per the FACE-Q (Perioral Rhytids Domain) Questionnaire. Baseline Face-Q Score	12.5 score on a scale Standard Deviation 18.99	13.0 score on a scale Standard Deviation 19.07
Subject's Perception of Treatment Effectiveness as Per the FACE-Q (Perioral Rhytids Domain) Questionnaire. Day 30 Face-Q Score	77.2 score on a scale Standard Deviation 25.78	73.9 score on a scale Standard Deviation 28.84
Subject's Perception of Treatment Effectiveness as Per the FACE-Q (Perioral Rhytids Domain) Questionnaire. Face-Q Change from Baseline to Day 30	64.7 score on a scale Standard Deviation 31.93	60.9 score on a scale Standard Deviation 36.10

SECONDARY outcome

Timeframe: Visit 1 (post-injection) 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 will bewas assessed using the baseline photograph. Each side of the mouth were assessed independently.

Outcome measures

Measure	RHA® Redensity With New Anesthetic Agent n=30 Participants 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.	RHA® Redensity With Lidocaine n=30 Participants 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.
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	30 Participants
Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) by the Treating Investigator (TI) Visit 2 (Day30)	30 Participants	30 Participants

SECONDARY outcome

Timeframe: Visit 1 (post-injection) 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 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.

Outcome measures

Measure	RHA® Redensity With New Anesthetic Agent n=30 Participants 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.	RHA® Redensity With Lidocaine n=30 Participants 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.
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	30 Participants
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	30 Participants

SECONDARY outcome

Timeframe: Visit 1 (post-injection) 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)

Outcome measures

Measure	RHA® Redensity With New Anesthetic Agent n=30 Participants 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.	RHA® Redensity With Lidocaine n=30 Participants 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.
Number of Both "Satisfied" or "Very Satisfied" Subjects With Study Treatment Using the Subject's Satisfaction Scale Visit 2 (Day 30) · Satisfied (i.e., 1-Very Satisfied + 2-Satisfied)	29 Participants	29 Participants
Number of Both "Satisfied" or "Very Satisfied" Subjects With Study Treatment Using the Subject's Satisfaction Scale Visit 1 (post-injection) · Satisfied (i.e., 1-Very Satisfied + 2-Satisfied)	29 Participants	29 Participants
Number of Both "Satisfied" or "Very Satisfied" Subjects With Study Treatment Using the Subject's Satisfaction Scale Visit 1 (post-injection) · Not Satisfied (i.e., 3-Neither Satisfied nor dissatisfied + 4-Dissatisfied + 5-Very Dissatisfied)	1 Participants	1 Participants
Number of Both "Satisfied" or "Very Satisfied" Subjects With Study Treatment Using the Subject's Satisfaction Scale Visit 2 (Day 30) · Not Satisfied (i.e., 3-Neither Satisfied nor dissatisfied + 4-Dissatisfied + 5-Very Dissatisfied)	1 Participants	1 Participants

SECONDARY outcome

Timeframe: During 30 days after injection

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.

Outcome measures

Measure	RHA® Redensity With New Anesthetic Agent n=30 Participants 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.	RHA® Redensity With Lidocaine n=30 Participants 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.
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 Pain	3 Participants	4 Participants
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 Bruising	12 Participants	16 Participants
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 Discoloration	10 Participants	10 Participants
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 Firmness	14 Participants	19 Participants
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 Itching	4 Participants	2 Participants
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 Lumps/Bumps	15 Participants	17 Participants
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 Redness	16 Participants	15 Participants
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 Swelling	21 Participants	19 Participants
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 Tenderness	13 Participants	12 Participants
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 Needle track marks	1 Participants	1 Participants
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 Injection Site Soreness	1 Participants	1 Participants

Adverse Events

RHA® Redensity With New Anesthetic Agent

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

RHA® Redensity With Lidocaine

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	RHA® Redensity With New Anesthetic Agent n=30 participants at risk 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.	RHA® Redensity With Lidocaine n=30 participants at risk 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.
Infections and infestations Osteomyelitis (toe on left foot)	3.3% 1/30 • Number of events 1 • 1 month (33 days, overall study duration)	3.3% 1/30 • Number of events 1 • 1 month (33 days, overall study duration)

Other adverse events

Measure	RHA® Redensity With New Anesthetic Agent n=30 participants at risk 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.	RHA® Redensity With Lidocaine n=30 participants at risk 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.
Gastrointestinal disorders Chapped lips	3.3% 1/30 • Number of events 1 • 1 month (33 days, overall study duration)	3.3% 1/30 • Number of events 1 • 1 month (33 days, overall study duration)
General disorders Injection site induration	6.7% 2/30 • Number of events 4 • 1 month (33 days, overall study duration)	6.7% 2/30 • Number of events 2 • 1 month (33 days, overall study duration)
General disorders Injection site mass	3.3% 1/30 • Number of events 1 • 1 month (33 days, overall study duration)	0.00% 0/30 • 1 month (33 days, overall study duration)
General disorders Injection site pain	3.3% 1/30 • Number of events 2 • 1 month (33 days, overall study duration)	3.3% 1/30 • Number of events 1 • 1 month (33 days, overall study duration)
Infections and infestations Osteomyelitis	3.3% 1/30 • Number of events 1 • 1 month (33 days, overall study duration)	3.3% 1/30 • Number of events 1 • 1 month (33 days, overall study duration)
Injury, poisoning and procedural complications Needle track marks	3.3% 1/30 • Number of events 2 • 1 month (33 days, overall study duration)	3.3% 1/30 • Number of events 1 • 1 month (33 days, overall study duration)

Additional Information

Clinical Project Manager

TEOXANE SA

Phone: +41(0) 22 344 96 36

Email: clinical@teoxane.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60