RHA® Redensity With New Anesthetic Agent - Perioral Rhytids

• Sponsor: Teoxane SA (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04069585
• Collaborator: (none)
• Enrollment: 30
• Locations: 3
• Arms: 2
• Actual Duration (Months): 12.4
• Patients Per Site: 10
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Aging; Pain	Device: RHA® Redensity with new anesthetic agent; Device: RHA® Redensity with lidocaine	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Split-face designSplit-face design
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized, Controlled, Double-blinded, Within-subject (Split-face), Multicenter, Prospective Clinical Study to Compare the Level of Pain Using the Dermal Filler RHA® Redensity Formulated With Two Different Anesthetics in the Treatment of Perioral Rhytids
• Actual Study Start Date: Oct 30, 2019
• Actual Primary Completion Date: Feb 24, 2020
• Actual Study Completion Date: Nov 9, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: RHA® Redensity with new anesthetic agent 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; 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.
Experimental: RHA® Redensity with lidocaine 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 lidocaine in a physiologic buffer.

Outcome Measures

Primary Outcome Measures

1. 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. [Visit 1 - During Injection]

   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

Secondary Outcome Measures

1. 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. [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

2. 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 (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"

3. 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 - 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

4. Subject's Perception of Treatment Effectiveness as Per the FACE-Q (Perioral Rhytids Domain) Questionnaire. [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).

5. Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) by the Treating Investigator (TI) [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.

6. 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) 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.

7. Number of Both "Satisfied" or "Very Satisfied" Subjects With Study Treatment Using the Subject's Satisfaction Scale [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)

8. 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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years and Older
• Sexes Eligible for Study: All
• Accepts 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 perioral rhytids (grade 2 or 3 on PR-SRS).

3. Perioral rhytids of the same PR-SRS grade on the left and right sides of the mouth.

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. Known sensitivity to local anesthetics of the amide type, history of multiple severe allergies, or history of anaphylactic shock.

4. Clinically significant active skin disease or infection in the perioral area within 6 months prior to study entry (TI discretion).

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. Malignancy (excluding non-melanoma skin cancer) within the past 5 years.

7. History or presence of condition or feature that may confound the interpretation of the results in the perioral region, for example, tattoo, significant facial hair, acne scaring, prior surgery in the area, potential for active disease or infection flare up such as herpes simplex.

8. History of skin cancer in the treatment area.

9. Elective, clinically significant facial procedures that may confound the interpretation of the results in the perioral region (TI discretion), prior to study enrollment.

10. Clinically active disease or infection in the perioral area or mouth (e.g., dental abscess).

11. Exposure to any other investigational drug/device within 90 days of entering the study.

12. Clinically significant alcohol or drug abuse, or history of poor cooperation or unreliability.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	California	Beverly Hills	California	United States	90120
2	Florida	Coral Gables	Florida	United States	33146
3	Chicago	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Teoxane SA

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Sep 10, 2019
• Statistical Analysis Plan - Feb 19, 2020

More Information

Publications

None provided.

• Responsible Party: Teoxane SA
• ClinicalTrials.gov Identifier: NCT04069585
• Other Study ID Numbers: TEO-RHA-1801
• First Posted: Aug 28, 2019
• Last Update Posted: Jan 24, 2022
• Last Verified: May 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Teoxane SA: Hyaluronic Acid; Perioral rhytids; Anesthetic; Lidocaine
• Additional relevant MeSH terms: Lidocaine; Anesthetics

Study Results

Participant Flow

Arm/Group Title	Bilateral Treatment RHA® Redensity With New Anesthetic Agent Vs RHA® Redensity With Lidocaine
Arm/Group Description	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.
Period Title: Overall Study
STARTED	30
COMPLETED	30
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Bilateral Treatment With RHA® Redensity With New Anesthetic Agent Vs RHA® Redensity With Lidocaine
Arm/Group Description	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.
Overall Participants	30
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64.3 (8.2)
Sex: Female, Male (Count of Participants)
Female	30 100%
Male	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	11 36.7%
Not Hispanic or Latino	19 63.3%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	30 100%
More than one race	0 0%
Unknown or Not Reported	0 0%
Fitzpatrick Skin Type (Count of Participants)
Types I to III as assessed by TI at screening	23 76.7%
Types IV to VI as assessed by TI at screening	7 23.3%

Outcome Measures

1. Primary Outcome

Title	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.
Description	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

Outcome Measure Data

Analysis Population Description

There were 30 participants enrolled and treated, the participants received bilateral, split-face treatment into the upper perioral rhytids.

Arm/Group Title	RHA® Redensity With Lidocaine	RHA® Redensity With New Anesthetic Agent
Arm/Group Description	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.	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.
Measure Participants	30	30
Mean (Standard Deviation) [mm]	22.4 (23.21)	25.0 (25.63)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	RHA® Redensity With Lidocaine, RHA® Redensity With New Anesthetic Agent
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	To achieve non-inferiority, the observed p-value must be <= 0.5 taking into account of the non-inferiority margin (i.e., 10mm difference in Pain VAS between the two treatment groups).
Statistical Test of Hypothesis	p-Value	<0.0002
	Comments	One-sided paired t-test
	Method	t-test, 1 sided
	Comments

2. Secondary Outcome

Title	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.
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	RHA® Redensity With Lidocaine	RHA® Redensity With New Anesthetic Agent
Arm/Group Description	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.	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.
Measure Participants	30	30
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)

3. Secondary Outcome

Title	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)
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	RHA® Redensity With Lidocaine	RHA® Redensity With New Anesthetic Agent
Arm/Group Description	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.	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.
Measure Participants	30	30
Visit 1 (Post-injection)	-1.5 (0.57)	-1.5 (0.63)
Visit 2 (Day 30)	-1.4 (0.57)	-1.4 (0.56)

4. Secondary Outcome

Title	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
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	RHA® Redensity With Lidocaine	RHA® Redensity With New Anesthetic Agent
Arm/Group Description	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.	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.
Measure Participants	30	30
Responder	29 96.7%	28 NaN
Not responder	1 3.3%	2 NaN
Responder	29 96.7%	29 NaN
Not responder	1 3.3%	1 NaN

5. Secondary Outcome

Title	Subject's Perception of Treatment Effectiveness as Per the FACE-Q (Perioral Rhytids Domain) Questionnaire.
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	RHA® Redensity With Lidocaine	RHA® Redensity With New Anesthetic Agent
Arm/Group Description	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.	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.
Measure Participants	30	30
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)

6. Secondary Outcome

Title	Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) by the Treating Investigator (TI)
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	RHA® Redensity With Lidocaine	RHA® Redensity With New Anesthetic Agent
Arm/Group Description	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.	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.
Measure Participants	30	30
Visit 1 (post-injection)	30 100%	30 NaN
Visit 2 (Day30)	30 100%	30 NaN

7. Secondary Outcome

Title	Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either "Much Improved" or "Improved") on GAI Scale According to Subject's Self-assessment
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	RHA® Redensity With Lidocaine	RHA® Redensity With New Anesthetic Agent
Arm/Group Description	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.	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.
Measure Participants	30	30
Visit 1 (post-injection)	30 100%	30 NaN
Visit 2 (Day 30)	30 100%	30 NaN

8. Secondary Outcome

Title	Number of Both "Satisfied" or "Very Satisfied" Subjects With Study Treatment Using the Subject's Satisfaction Scale
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	RHA® Redensity With Lidocaine	RHA® Redensity With New Anesthetic Agent
Arm/Group Description	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.	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.
Measure Participants	30	30
Satisfied (i.e., 1-Very Satisfied + 2-Satisfied)	29 96.7%	29 NaN
Not Satisfied (i.e., 3-Neither Satisfied nor dissatisfied + 4-Dissatisfied + 5-Very Dissatisfied)	1 3.3%	1 NaN
Satisfied (i.e., 1-Very Satisfied + 2-Satisfied)	29 96.7%	29 NaN
Not Satisfied (i.e., 3-Neither Satisfied nor dissatisfied + 4-Dissatisfied + 5-Very Dissatisfied)	1 3.3%	1 NaN

9. Secondary Outcome

Title	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
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	RHA® Redensity With Lidocaine	RHA® Redensity With New Anesthetic Agent
Arm/Group Description	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.	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.
Measure Participants	30	30
Bruising	16 53.3%	12 NaN
Discoloration	10 33.3%	10 NaN
Firmness	19 63.3%	14 NaN
Itching	2 6.7%	4 NaN
Lumps/Bumps	17 56.7%	15 NaN
Pain	4 13.3%	3 NaN
Redness	15 50%	16 NaN
Swelling	19 63.3%	21 NaN
Tenderness	12 40%	13 NaN
Needle track marks	1 3.3%	1 NaN
Injection Site Soreness	1 3.3%	1 NaN

Adverse Events

Time Frame	1 month (33 days, overall study duration)
Arm/Group Title	RHA® Redensity With New Anesthetic Agent		RHA® Redensity With Lidocaine
Arm/Group Description	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: 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.
All Cause Mortality
	RHA® Redensity With New Anesthetic Agent		RHA® Redensity With Lidocaine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)
Serious Adverse Events
	RHA® Redensity With New Anesthetic Agent		RHA® Redensity With Lidocaine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/30 (3.3%)		1/30 (3.3%)
Infections and infestations
Osteomyelitis (toe on left foot)	1/30 (3.3%)	1	1/30 (3.3%)	1
Other (Not Including Serious) Adverse Events
	RHA® Redensity With New Anesthetic Agent		RHA® Redensity With Lidocaine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/30 (20%)		5/30 (16.7%)
Gastrointestinal disorders
Chapped lips	1/30 (3.3%)	1	1/30 (3.3%)	1
General disorders
Injection site induration	2/30 (6.7%)	4	2/30 (6.7%)	2
Injection site mass	1/30 (3.3%)	1	0/30 (0%)	0
Injection site pain	1/30 (3.3%)	2	1/30 (3.3%)	1
Infections and infestations
Osteomyelitis	1/30 (3.3%)	1	1/30 (3.3%)	1
Injury, poisoning and procedural complications
Needle track marks	1/30 (3.3%)	2	1/30 (3.3%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.