Trial Outcomes & Findings for RHA Redensity - Perioral Rhytids (NCT NCT03092219)

Last Updated: 2023-06-22

Results Overview

The PR-SRS is a validated 4-point static scale for assessing perioral rhytids severity. Possible scores range from 0 (Absent) to 3 (Severe). Change = (Week 8 - Baseline score). A PR-SRS change of 1-grade will be considered clinically significant. The No-Treatment control group after treatment was not pooled for this primary outcome measure.

Recruitment status

COMPLETED

Study phase

Target enrollment

202 participants

Primary outcome timeframe

Week 8 after last treatment

Results posted on

2023-06-22

Participant Flow

A total of 202 subjects were randomized with 150 subjects allocated to TEOSYAL RHA® Redensity and 52 subjects allocated to No-Treatment control.

Participant milestones

Participant milestones
Measure	TEOSYAL RHA Redensity Injection of TEOSYAL RHA Redensity into the perioral lines. Up to 6.0 mL (max 3 mL for upper and max 3 mL for lower) injected into the dermis, including the superficial dermis. Touch-up treatment provided at 2 weeks (up to 6.0 mL). TEOSYAL RHA Redensity: 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. It is supplied in individual treatment syringes with 30G ½ inch disposable sterile needles.	No Treatment No treatment control group.
Overall Study STARTED	150	52
Overall Study Baseline / ITT Population	150	51
Overall Study Primary Analysis Endpoint	150	51
Overall Study Pooled SAFT Population	150	50
Overall Study COMPLETED	143	48
Overall Study NOT COMPLETED	7	4

Reasons for withdrawal

Reasons for withdrawal
Measure	TEOSYAL RHA Redensity Injection of TEOSYAL RHA Redensity into the perioral lines. Up to 6.0 mL (max 3 mL for upper and max 3 mL for lower) injected into the dermis, including the superficial dermis. Touch-up treatment provided at 2 weeks (up to 6.0 mL). TEOSYAL RHA Redensity: 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. It is supplied in individual treatment syringes with 30G ½ inch disposable sterile needles.	No Treatment No treatment control group.
Overall Study Protocol Violation	7	4

Baseline Characteristics

This demographic variable only count the population with a smoking history. 143 from 150 participants have a smoking history in the RHA Redensity (7 missing values). 50 from 51 participants have a smoking history in the no-treatment group (1 missing value).

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TEOSYAL RHA Redensity n=150 Participants Injection of TEOSYAL RHA Redensity into the perioral lines. Up to 6.0 mL (max 3 mL for upper and max 3 mL for lower) injected into the dermis, including the superficial dermis. Touch-up treatment provided at 2 weeks (up to 6.0 mL). TEOSYAL RHA Redensity: 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. It is supplied in individual treatment syringes with 30G ½ inch disposable sterile needles.	No Treatment n=51 Participants No treatment control group	Total n=201 Participants Total of all reporting groups
Age, Continuous	61.6 years STANDARD_DEVIATION 7.2 • n=150 Participants	60.7 years STANDARD_DEVIATION 7.6 • n=51 Participants	61.4 years STANDARD_DEVIATION 7.3 • n=201 Participants
Sex: Female, Male Female	147 Participants n=150 Participants	50 Participants n=51 Participants	197 Participants n=201 Participants
Sex: Female, Male Male	3 Participants n=150 Participants	1 Participants n=51 Participants	4 Participants n=201 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	25 Participants n=150 Participants	10 Participants n=51 Participants	35 Participants n=201 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	125 Participants n=150 Participants	41 Participants n=51 Participants	166 Participants n=201 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=150 Participants	0 Participants n=51 Participants	0 Participants n=201 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=150 Participants	0 Participants n=51 Participants	1 Participants n=201 Participants
Race (NIH/OMB) Asian	2 Participants n=150 Participants	0 Participants n=51 Participants	2 Participants n=201 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=150 Participants	0 Participants n=51 Participants	0 Participants n=201 Participants
Race (NIH/OMB) Black or African American	4 Participants n=150 Participants	0 Participants n=51 Participants	4 Participants n=201 Participants
Race (NIH/OMB) White	143 Participants n=150 Participants	51 Participants n=51 Participants	194 Participants n=201 Participants
Race (NIH/OMB) More than one race	0 Participants n=150 Participants	0 Participants n=51 Participants	0 Participants n=201 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=150 Participants	0 Participants n=51 Participants	0 Participants n=201 Participants
Region of Enrollment Canada	29 participants n=150 Participants	9 participants n=51 Participants	39 participants n=201 Participants
Region of Enrollment United States	121 participants n=150 Participants	42 participants n=51 Participants	163 participants n=201 Participants
Fitzpatrick Skin Type Type I - III	110 Participants n=150 Participants	36 Participants n=51 Participants	146 Participants n=201 Participants
Fitzpatrick Skin Type Type IV - VI	40 Participants n=150 Participants	15 Participants n=51 Participants	55 Participants n=201 Participants
BMI	25.3 kg/m^2 STANDARD_DEVIATION 4.6 • n=150 Participants	24.8 kg/m^2 STANDARD_DEVIATION 4.9 • n=51 Participants	25.1 kg/m^2 STANDARD_DEVIATION 4.7 • n=201 Participants
Smoking History Smoke past 5 yrs - No	120 Participants n=143 Participants • This demographic variable only count the population with a smoking history. 143 from 150 participants have a smoking history in the RHA Redensity (7 missing values). 50 from 51 participants have a smoking history in the no-treatment group (1 missing value).	41 Participants n=50 Participants • This demographic variable only count the population with a smoking history. 143 from 150 participants have a smoking history in the RHA Redensity (7 missing values). 50 from 51 participants have a smoking history in the no-treatment group (1 missing value).	161 Participants n=193 Participants • This demographic variable only count the population with a smoking history. 143 from 150 participants have a smoking history in the RHA Redensity (7 missing values). 50 from 51 participants have a smoking history in the no-treatment group (1 missing value).
Smoking History Smoke past 5 yrs - Yes	23 Participants n=143 Participants • This demographic variable only count the population with a smoking history. 143 from 150 participants have a smoking history in the RHA Redensity (7 missing values). 50 from 51 participants have a smoking history in the no-treatment group (1 missing value).	9 Participants n=50 Participants • This demographic variable only count the population with a smoking history. 143 from 150 participants have a smoking history in the RHA Redensity (7 missing values). 50 from 51 participants have a smoking history in the no-treatment group (1 missing value).	32 Participants n=193 Participants • This demographic variable only count the population with a smoking history. 143 from 150 participants have a smoking history in the RHA Redensity (7 missing values). 50 from 51 participants have a smoking history in the no-treatment group (1 missing value).
Smoking History Smoke currently - No	123 Participants n=143 Participants • This demographic variable only count the population with a smoking history. 143 from 150 participants have a smoking history in the RHA Redensity (7 missing values). 50 from 51 participants have a smoking history in the no-treatment group (1 missing value).	45 Participants n=50 Participants • This demographic variable only count the population with a smoking history. 143 from 150 participants have a smoking history in the RHA Redensity (7 missing values). 50 from 51 participants have a smoking history in the no-treatment group (1 missing value).	168 Participants n=193 Participants • This demographic variable only count the population with a smoking history. 143 from 150 participants have a smoking history in the RHA Redensity (7 missing values). 50 from 51 participants have a smoking history in the no-treatment group (1 missing value).
Smoking History Smoke currently - Yes, ≤1 pack equivalents/day	20 Participants n=143 Participants • This demographic variable only count the population with a smoking history. 143 from 150 participants have a smoking history in the RHA Redensity (7 missing values). 50 from 51 participants have a smoking history in the no-treatment group (1 missing value).	4 Participants n=50 Participants • This demographic variable only count the population with a smoking history. 143 from 150 participants have a smoking history in the RHA Redensity (7 missing values). 50 from 51 participants have a smoking history in the no-treatment group (1 missing value).	24 Participants n=193 Participants • This demographic variable only count the population with a smoking history. 143 from 150 participants have a smoking history in the RHA Redensity (7 missing values). 50 from 51 participants have a smoking history in the no-treatment group (1 missing value).
Smoking History Smoke currently - Yes, ≥1 pack equivalents/day	0 Participants n=143 Participants • This demographic variable only count the population with a smoking history. 143 from 150 participants have a smoking history in the RHA Redensity (7 missing values). 50 from 51 participants have a smoking history in the no-treatment group (1 missing value).	1 Participants n=50 Participants • This demographic variable only count the population with a smoking history. 143 from 150 participants have a smoking history in the RHA Redensity (7 missing values). 50 from 51 participants have a smoking history in the no-treatment group (1 missing value).	1 Participants n=193 Participants • This demographic variable only count the population with a smoking history. 143 from 150 participants have a smoking history in the RHA Redensity (7 missing values). 50 from 51 participants have a smoking history in the no-treatment group (1 missing value).
Sun Exposure Protects face : Never	6 Participants n=143 Participants • 143 from 150 participants have a Sun exposure in the RHA Redensity (7 missing values). 50 from 51 participants have a Sun exposure in the no-treatment group (1 missing values).	2 Participants n=50 Participants • 143 from 150 participants have a Sun exposure in the RHA Redensity (7 missing values). 50 from 51 participants have a Sun exposure in the no-treatment group (1 missing values).	8 Participants n=193 Participants • 143 from 150 participants have a Sun exposure in the RHA Redensity (7 missing values). 50 from 51 participants have a Sun exposure in the no-treatment group (1 missing values).
Sun Exposure Protects face : Sometimes	31 Participants n=143 Participants • 143 from 150 participants have a Sun exposure in the RHA Redensity (7 missing values). 50 from 51 participants have a Sun exposure in the no-treatment group (1 missing values).	12 Participants n=50 Participants • 143 from 150 participants have a Sun exposure in the RHA Redensity (7 missing values). 50 from 51 participants have a Sun exposure in the no-treatment group (1 missing values).	43 Participants n=193 Participants • 143 from 150 participants have a Sun exposure in the RHA Redensity (7 missing values). 50 from 51 participants have a Sun exposure in the no-treatment group (1 missing values).
Sun Exposure Protects face : Usually	42 Participants n=143 Participants • 143 from 150 participants have a Sun exposure in the RHA Redensity (7 missing values). 50 from 51 participants have a Sun exposure in the no-treatment group (1 missing values).	10 Participants n=50 Participants • 143 from 150 participants have a Sun exposure in the RHA Redensity (7 missing values). 50 from 51 participants have a Sun exposure in the no-treatment group (1 missing values).	52 Participants n=193 Participants • 143 from 150 participants have a Sun exposure in the RHA Redensity (7 missing values). 50 from 51 participants have a Sun exposure in the no-treatment group (1 missing values).
Sun Exposure Protects face : Always	64 Participants n=143 Participants • 143 from 150 participants have a Sun exposure in the RHA Redensity (7 missing values). 50 from 51 participants have a Sun exposure in the no-treatment group (1 missing values).	26 Participants n=50 Participants • 143 from 150 participants have a Sun exposure in the RHA Redensity (7 missing values). 50 from 51 participants have a Sun exposure in the no-treatment group (1 missing values).	90 Participants n=193 Participants • 143 from 150 participants have a Sun exposure in the RHA Redensity (7 missing values). 50 from 51 participants have a Sun exposure in the no-treatment group (1 missing values).
Sun Exposure Artificial Tanning : None	131 Participants n=143 Participants • 143 from 150 participants have a Sun exposure in the RHA Redensity (7 missing values). 50 from 51 participants have a Sun exposure in the no-treatment group (1 missing values).	43 Participants n=50 Participants • 143 from 150 participants have a Sun exposure in the RHA Redensity (7 missing values). 50 from 51 participants have a Sun exposure in the no-treatment group (1 missing values).	174 Participants n=193 Participants • 143 from 150 participants have a Sun exposure in the RHA Redensity (7 missing values). 50 from 51 participants have a Sun exposure in the no-treatment group (1 missing values).
Sun Exposure Artificial Tanning : ≤1per session/month	11 Participants n=143 Participants • 143 from 150 participants have a Sun exposure in the RHA Redensity (7 missing values). 50 from 51 participants have a Sun exposure in the no-treatment group (1 missing values).	4 Participants n=50 Participants • 143 from 150 participants have a Sun exposure in the RHA Redensity (7 missing values). 50 from 51 participants have a Sun exposure in the no-treatment group (1 missing values).	15 Participants n=193 Participants • 143 from 150 participants have a Sun exposure in the RHA Redensity (7 missing values). 50 from 51 participants have a Sun exposure in the no-treatment group (1 missing values).
Sun Exposure Artificial Tanning : ≥1 per session/month	0 Participants n=143 Participants • 143 from 150 participants have a Sun exposure in the RHA Redensity (7 missing values). 50 from 51 participants have a Sun exposure in the no-treatment group (1 missing values).	3 Participants n=50 Participants • 143 from 150 participants have a Sun exposure in the RHA Redensity (7 missing values). 50 from 51 participants have a Sun exposure in the no-treatment group (1 missing values).	3 Participants n=193 Participants • 143 from 150 participants have a Sun exposure in the RHA Redensity (7 missing values). 50 from 51 participants have a Sun exposure in the no-treatment group (1 missing values).
Alcohol History Alcohol past 5 yrs : No	36 Participants n=143 Participants • 143 from 150 participants have an alcohol history in the RHA Redensity (7 missing values). 50 from 51 participants have an alcohol history in the no-treatment group (1 missing values).	7 Participants n=50 Participants • 143 from 150 participants have an alcohol history in the RHA Redensity (7 missing values). 50 from 51 participants have an alcohol history in the no-treatment group (1 missing values).	43 Participants n=193 Participants • 143 from 150 participants have an alcohol history in the RHA Redensity (7 missing values). 50 from 51 participants have an alcohol history in the no-treatment group (1 missing values).
Alcohol History Alcohol past 5 yrs : Yes	107 Participants n=143 Participants • 143 from 150 participants have an alcohol history in the RHA Redensity (7 missing values). 50 from 51 participants have an alcohol history in the no-treatment group (1 missing values).	43 Participants n=50 Participants • 143 from 150 participants have an alcohol history in the RHA Redensity (7 missing values). 50 from 51 participants have an alcohol history in the no-treatment group (1 missing values).	150 Participants n=193 Participants • 143 from 150 participants have an alcohol history in the RHA Redensity (7 missing values). 50 from 51 participants have an alcohol history in the no-treatment group (1 missing values).
Alcohol History Alcohol currently : No	38 Participants n=143 Participants • 143 from 150 participants have an alcohol history in the RHA Redensity (7 missing values). 50 from 51 participants have an alcohol history in the no-treatment group (1 missing values).	8 Participants n=50 Participants • 143 from 150 participants have an alcohol history in the RHA Redensity (7 missing values). 50 from 51 participants have an alcohol history in the no-treatment group (1 missing values).	46 Participants n=193 Participants • 143 from 150 participants have an alcohol history in the RHA Redensity (7 missing values). 50 from 51 participants have an alcohol history in the no-treatment group (1 missing values).
Alcohol History Alcohol currently : Yes, ≤1 drink per day	101 Participants n=143 Participants • 143 from 150 participants have an alcohol history in the RHA Redensity (7 missing values). 50 from 51 participants have an alcohol history in the no-treatment group (1 missing values).	40 Participants n=50 Participants • 143 from 150 participants have an alcohol history in the RHA Redensity (7 missing values). 50 from 51 participants have an alcohol history in the no-treatment group (1 missing values).	141 Participants n=193 Participants • 143 from 150 participants have an alcohol history in the RHA Redensity (7 missing values). 50 from 51 participants have an alcohol history in the no-treatment group (1 missing values).
Alcohol History Alcohol currently : Yes, ≥ 1 drink per day	3 Participants n=143 Participants • 143 from 150 participants have an alcohol history in the RHA Redensity (7 missing values). 50 from 51 participants have an alcohol history in the no-treatment group (1 missing values).	2 Participants n=50 Participants • 143 from 150 participants have an alcohol history in the RHA Redensity (7 missing values). 50 from 51 participants have an alcohol history in the no-treatment group (1 missing values).	5 Participants n=193 Participants • 143 from 150 participants have an alcohol history in the RHA Redensity (7 missing values). 50 from 51 participants have an alcohol history in the no-treatment group (1 missing values).

PRIMARY outcome

Timeframe: Week 8 after last treatment

Population: The Intent-to-Treat Population was used for this analysis. The ITT Population consisted of all subjects randomized in the TEOSYAL RHA® Redensity group and all subjects randomized in the No-Treatment control group (with the notable exception of 1 subject who received treatment with study device at Visit 1 and was censored from the ITT).

Outcome measures

Outcome measures
Measure	TEOSYAL RHA Redensity n=150 Participants Injection of TEOSYAL RHA Redensity into the perioral lines. Up to 6.0 mL (max 3 mL for upper and max 3 mL for lower) injected into the dermis, including the superficial dermis. Touch-up treatment provided at 2 weeks (up to 6.0 mL). TEOSYAL RHA Redensity: 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. It is supplied in individual treatment syringes with 30G ½ inch disposable sterile needles.	No Treatment n=51 Participants No treatment control group.
Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Blinded Live Evaluator (BLE) at Week 8 After Last Treatment. Responder	121 Participants	4 Participants
Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Blinded Live Evaluator (BLE) at Week 8 After Last Treatment. Not Responder	29 Participants	47 Participants

SECONDARY outcome

Timeframe: Baseline, Weeks 4 and 8 after last treatment

Population: The Intent-to-Treat Population (n=150 for the TEOSYAL RHA Redensity group and n=51 for the No treatment group) was used for this analysis. Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available.

The FACE-Q measures the experience and outcomes of aesthetic facial procedures from the patient's perspective. The FACE-Q questionnaire is composed of 6 questions with a score linked to answers (1 being 'Not at all' and 4 being 'Extremely'). To calculate the FACE-Q score, outcomes from all 6 questions were pooled, data were transformed so that higher scores reflected a superior outcome and adapted to a 100- unit scale. The No-Treatment control group after treatment was not pooled for this secondary outcome measure.

Outcome measures

Outcome measures
Measure	TEOSYAL RHA Redensity n=150 Participants Injection of TEOSYAL RHA Redensity into the perioral lines. Up to 6.0 mL (max 3 mL for upper and max 3 mL for lower) injected into the dermis, including the superficial dermis. Touch-up treatment provided at 2 weeks (up to 6.0 mL). TEOSYAL RHA Redensity: 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. It is supplied in individual treatment syringes with 30G ½ inch disposable sterile needles.	No Treatment n=51 Participants No treatment control group.
Subject's Perception of Treatment Effectiveness as Per the FACE-Q Scale (Perioral Rhytid Domain) Questionnaire at Baseline, Weeks 4 and 8 After Last Treatment. Face-Q Change from Baseline to Week 4	46.5 score on a scale Standard Deviation 27.3	0.3 score on a scale Standard Deviation 11.5
Subject's Perception of Treatment Effectiveness as Per the FACE-Q Scale (Perioral Rhytid Domain) Questionnaire at Baseline, Weeks 4 and 8 After Last Treatment. Week 8 Face-Q Score	68.9 score on a scale Standard Deviation 24.3	21.1 score on a scale Standard Deviation 20.1
Subject's Perception of Treatment Effectiveness as Per the FACE-Q Scale (Perioral Rhytid Domain) Questionnaire at Baseline, Weeks 4 and 8 After Last Treatment. Face-Q Change from Baseline to Week 8	45.6 score on a scale Standard Deviation 26.4	-3.8 score on a scale Standard Deviation 12.1
Subject's Perception of Treatment Effectiveness as Per the FACE-Q Scale (Perioral Rhytid Domain) Questionnaire at Baseline, Weeks 4 and 8 After Last Treatment. Baseline Face-Q Score	23.3 score on a scale Standard Deviation 20.8	24.2 score on a scale Standard Deviation 20.2
Subject's Perception of Treatment Effectiveness as Per the FACE-Q Scale (Perioral Rhytid Domain) Questionnaire at Baseline, Weeks 4 and 8 After Last Treatment. Week 4 Face-Q Score	70.0 score on a scale Standard Deviation 23.8	24.0 score on a scale Standard Deviation 21.5

SECONDARY outcome

Timeframe: Weeks 4 and 8 after last treatment

Population: The Intent-to-Treat Population (n=150 for the Teosyal RHA Redensity group and n=51 for the No treatment group) was used for this analysis. Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available.

The Global Aesthetic Improvement (GAI) is a subjective, balanced, 5-point dynamic scale assessing cosmetic improvement. Possible scores range from "much improved", "improved", "no change", "worse", to "much worse". The GAI will be assessed using the pre-injection baseline photograph. The No-Treatment control group after treatment was not pooled for this secondary outcome measure.

Outcome measures

Outcome measures
Measure	TEOSYAL RHA Redensity n=150 Participants Injection of TEOSYAL RHA Redensity into the perioral lines. Up to 6.0 mL (max 3 mL for upper and max 3 mL for lower) injected into the dermis, including the superficial dermis. Touch-up treatment provided at 2 weeks (up to 6.0 mL). TEOSYAL RHA Redensity: 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. It is supplied in individual treatment syringes with 30G ½ inch disposable sterile needles.	No Treatment n=51 Participants No treatment control group.
Number of Subjects Who Scored Themselves Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale at Week 8 and 4 After Last Treatment. Week 4 · Improved	144 Participants	1 Participants
Number of Subjects Who Scored Themselves Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale at Week 8 and 4 After Last Treatment. Week 4 · No Improvement	2 Participants	46 Participants
Number of Subjects Who Scored Themselves Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale at Week 8 and 4 After Last Treatment. Week 8 · No Improvement	6 Participants	49 Participants
Number of Subjects Who Scored Themselves Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale at Week 8 and 4 After Last Treatment. Week 8 · Missing values	3 Participants	2 Participants
Number of Subjects Who Scored Themselves Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale at Week 8 and 4 After Last Treatment. Week 4 · Missing values	4 Participants	4 Participants
Number of Subjects Who Scored Themselves Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale at Week 8 and 4 After Last Treatment. Week 8 · Improved	141 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 8 after last treatment

Outcome measures

Outcome measures
Measure	TEOSYAL RHA Redensity n=150 Participants Injection of TEOSYAL RHA Redensity into the perioral lines. Up to 6.0 mL (max 3 mL for upper and max 3 mL for lower) injected into the dermis, including the superficial dermis. Touch-up treatment provided at 2 weeks (up to 6.0 mL). TEOSYAL RHA Redensity: 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. It is supplied in individual treatment syringes with 30G ½ inch disposable sterile needles.	No Treatment n=51 Participants No treatment control group.
Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE) at Week 8 After Last Treatment. Improved	135 Participants	4 Participants
Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE) at Week 8 After Last Treatment. No Improvement	11 Participants	44 Participants
Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE) at Week 8 After Last Treatment. Missing values	4 Participants	3 Participants

SECONDARY outcome

Timeframe: Week 8 after last treatment

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). The No-Treatment control group after treatment was not pooled for this secondary outcome measure.

Outcome measures

Outcome measures
Measure	TEOSYAL RHA Redensity n=150 Participants Injection of TEOSYAL RHA Redensity into the perioral lines. Up to 6.0 mL (max 3 mL for upper and max 3 mL for lower) injected into the dermis, including the superficial dermis. Touch-up treatment provided at 2 weeks (up to 6.0 mL). TEOSYAL RHA Redensity: 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. It is supplied in individual treatment syringes with 30G ½ inch disposable sterile needles.	No Treatment n=51 Participants No treatment control group.
Number of Subjects "Satisfied" or "Very Satisfied" With Study Treatment Using the Subject Satisfaction Scale at Week 8 After Last Treatment. Satisfied	133 Participants	4 Participants
Number of Subjects "Satisfied" or "Very Satisfied" With Study Treatment Using the Subject Satisfaction Scale at Week 8 After Last Treatment. Not Satisfied	14 Participants	39 Participants
Number of Subjects "Satisfied" or "Very Satisfied" With Study Treatment Using the Subject Satisfaction Scale at Week 8 After Last Treatment. Missing values	3 Participants	8 Participants

SECONDARY outcome

Timeframe: Baseline through Week 52 following the last treatment and 4 weeks following re-treatment

The Treating Investigator will assess adverse events and record details of seriousness, severity, duration, and action taken with the study device, and relationship to the study device. AEs will be reported from the time of consent until week 52 or to 1 month following the last treatment.

Outcome measures

Outcome measures
Measure	TEOSYAL RHA Redensity n=200 Participants Injection of TEOSYAL RHA Redensity into the perioral lines. Up to 6.0 mL (max 3 mL for upper and max 3 mL for lower) injected into the dermis, including the superficial dermis. Touch-up treatment provided at 2 weeks (up to 6.0 mL). TEOSYAL RHA Redensity: 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. It is supplied in individual treatment syringes with 30G ½ inch disposable sterile needles.	No Treatment No treatment control group.
Number of Participants With Adverse Events for the Safety Evaluation of TEOSYAL RHA® Redensity. Any Treatment Emergent Adverse Event	120 Participants	—
Number of Participants With Adverse Events for the Safety Evaluation of TEOSYAL RHA® Redensity. Any Treatment Related Adverse Event	73 Participants	—
Number of Participants With Adverse Events for the Safety Evaluation of TEOSYAL RHA® Redensity. Any Serious Adverse Event	7 Participants	—
Number of Participants With Adverse Events for the Safety Evaluation of TEOSYAL RHA® Redensity. Any Treatment Related Serious Adverse Event	0 Participants	—
Number of Participants With Adverse Events for the Safety Evaluation of TEOSYAL RHA® Redensity. Any Unexpected Adverse Device Effects	0 Participants	—

SECONDARY outcome

Timeframe: During 14 days after initial treatment and touch-up (2 weeks)

Population: All numbers are based on the number of total number of subjects who provided diary answers after their treatment.

The subjects will receive a diary booklet and instructions for recording his/her observations of the Common Treatment Responses of the study treatments for the first 14 days after treatment. The diary will be discussed during telephone follow-up visit. Subjects should complete the diary at approximately the same time each day (i.e., am or pm). The subject diary captures 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 14-day patient CTR diary includes 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. The table presents the number of subjects experiencing at least 1 Common Treatment Response (CTR).

Outcome measures

Outcome measures
Measure	TEOSYAL RHA Redensity n=200 Participants Injection of TEOSYAL RHA Redensity into the perioral lines. Up to 6.0 mL (max 3 mL for upper and max 3 mL for lower) injected into the dermis, including the superficial dermis. Touch-up treatment provided at 2 weeks (up to 6.0 mL). TEOSYAL RHA Redensity: 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. It is supplied in individual treatment syringes with 30G ½ inch disposable sterile needles.	No Treatment No treatment control group.
Number of Post-Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for the Safety Evaluation of TEOSYAL RHA® Redensity. Initial Treatment : Lumps/Bumps	115 number of subjects	—
Number of Post-Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for the Safety Evaluation of TEOSYAL RHA® Redensity. Touch-up Treatment : Lumps/Bumps	59 number of subjects	—
Number of Post-Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for the Safety Evaluation of TEOSYAL RHA® Redensity. Touch-up Treatment : Bruising	82 number of subjects	—
Number of Post-Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for the Safety Evaluation of TEOSYAL RHA® Redensity. Initial Treatment : Redness	131 number of subjects	—
Number of Post-Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for the Safety Evaluation of TEOSYAL RHA® Redensity. Initial Treatment : Pain	54 number of subjects	—
Number of Post-Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for the Safety Evaluation of TEOSYAL RHA® Redensity. Initial Treatment : Tenderness	105 number of subjects	—
Number of Post-Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for the Safety Evaluation of TEOSYAL RHA® Redensity. Initial Treatment : Firmess	115 number of subjects	—
Number of Post-Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for the Safety Evaluation of TEOSYAL RHA® Redensity. Initial Treatment : Swelling	146 number of subjects	—
Number of Post-Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for the Safety Evaluation of TEOSYAL RHA® Redensity. Initial Treatment : Bruising	154 number of subjects	—
Number of Post-Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for the Safety Evaluation of TEOSYAL RHA® Redensity. Initial Treatment : Itching	31 number of subjects	—
Number of Post-Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for the Safety Evaluation of TEOSYAL RHA® Redensity. Initial Treatment : Discoloration	94 number of subjects	—
Number of Post-Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for the Safety Evaluation of TEOSYAL RHA® Redensity. Touch-up Treatment : Redness	85 number of subjects	—
Number of Post-Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for the Safety Evaluation of TEOSYAL RHA® Redensity. Touch-up Treatment : Pain	29 number of subjects	—
Number of Post-Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for the Safety Evaluation of TEOSYAL RHA® Redensity. Touch-up Treatment : Tenderness	54 number of subjects	—
Number of Post-Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for the Safety Evaluation of TEOSYAL RHA® Redensity. Touch-up Treatment : Firmess	57 number of subjects	—
Number of Post-Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for the Safety Evaluation of TEOSYAL RHA® Redensity. Touch-up Treatment : Swelling	84 number of subjects	—
Number of Post-Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for the Safety Evaluation of TEOSYAL RHA® Redensity. Touch-up Treatment : Itching	11 number of subjects	—
Number of Post-Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for the Safety Evaluation of TEOSYAL RHA® Redensity. Touch-up Treatment : Discoloration	39 number of subjects	—

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 12, 16, 24, 36 and 52

Population: All numbers are based on the total number of subjects where the data were available.

The Injection Site Pain (during injection and post-injection) will be self-assessed by the subject using a 100 mm Visual Analog Scale (VAS). VAS is a 100 mm Visual Analog Scale with 0 meaning no pain and 100 meaning intolerable pain.

Outcome measures

Outcome measures
Measure	TEOSYAL RHA Redensity n=200 Participants Injection of TEOSYAL RHA Redensity into the perioral lines. Up to 6.0 mL (max 3 mL for upper and max 3 mL for lower) injected into the dermis, including the superficial dermis. Touch-up treatment provided at 2 weeks (up to 6.0 mL). TEOSYAL RHA Redensity: 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. It is supplied in individual treatment syringes with 30G ½ inch disposable sterile needles.	No Treatment No treatment control group.
Assessment of Injection Site Pain Felt by the Patient for the Safety Evaluation of TEOSYAL RHA® Redensity. Baseline VAS pain score during injection	19.9 score on a scale Standard Deviation 19.7	—
Assessment of Injection Site Pain Felt by the Patient for the Safety Evaluation of TEOSYAL RHA® Redensity. Week 2 VAS pain score during injection	25.4 score on a scale Standard Deviation 23.3	—
Assessment of Injection Site Pain Felt by the Patient for the Safety Evaluation of TEOSYAL RHA® Redensity. Week 2 VAS pain score 15 minutes after	4.4 score on a scale Standard Deviation 10.1	—
Assessment of Injection Site Pain Felt by the Patient for the Safety Evaluation of TEOSYAL RHA® Redensity. Week 12 VAS pain score during injection	14.3 score on a scale Standard Deviation 10.8	—
Assessment of Injection Site Pain Felt by the Patient for the Safety Evaluation of TEOSYAL RHA® Redensity. Week 12 VAS pain score 15 minutes after	2.0 score on a scale Standard Deviation 4.9	—
Assessment of Injection Site Pain Felt by the Patient for the Safety Evaluation of TEOSYAL RHA® Redensity. Week 16 VAS pain score during injection	25.0 score on a scale Standard Deviation 20.2	—
Assessment of Injection Site Pain Felt by the Patient for the Safety Evaluation of TEOSYAL RHA® Redensity. Week 16 VAS pain score 15 minutes after	0.8 score on a scale Standard Deviation 1.5	—
Assessment of Injection Site Pain Felt by the Patient for the Safety Evaluation of TEOSYAL RHA® Redensity. Week 24 VAS pain score during injection	24.8 score on a scale Standard Deviation 28.3	—
Assessment of Injection Site Pain Felt by the Patient for the Safety Evaluation of TEOSYAL RHA® Redensity. Week 24 VAS pain score 15 minutes after	2.7 score on a scale Standard Deviation 6.3	—
Assessment of Injection Site Pain Felt by the Patient for the Safety Evaluation of TEOSYAL RHA® Redensity. Week 36 VAS pain score during injection	40.6 score on a scale Standard Deviation 23.6	—
Assessment of Injection Site Pain Felt by the Patient for the Safety Evaluation of TEOSYAL RHA® Redensity. Week 52 VAS pain score during injection	19.7 score on a scale Standard Deviation 21.9	—
Assessment of Injection Site Pain Felt by the Patient for the Safety Evaluation of TEOSYAL RHA® Redensity. Week 52 VAS pain score 15 minutes after	3.6 score on a scale Standard Deviation 10.8	—
Assessment of Injection Site Pain Felt by the Patient for the Safety Evaluation of TEOSYAL RHA® Redensity. Baseline VAS pain score 15 minutes after	3.1 score on a scale Standard Deviation 8.3	—
Assessment of Injection Site Pain Felt by the Patient for the Safety Evaluation of TEOSYAL RHA® Redensity. Week 36 VAS pain score 15 minutes after	5.6 score on a scale Standard Deviation 6.2	—

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 24, 36, and 52 after the last treatment, (i.e., initial or touch-up treatment) and 4 weeks after a Repeat-Treatment.

Population: All percentages are based on the total number of subjects where the data were available.

This Lip functionality testing was conducted by the Treating Investigator (TI) at each follow-up visit and pre- and post-injection at each injection, which occurred at Baseline, Weeks 2, 4, 8, 12, 16, 24, 36, and 52 after the last treatment.

Outcome measures

Outcome measures
Measure	TEOSYAL RHA Redensity n=200 Participants Injection of TEOSYAL RHA Redensity into the perioral lines. Up to 6.0 mL (max 3 mL for upper and max 3 mL for lower) injected into the dermis, including the superficial dermis. Touch-up treatment provided at 2 weeks (up to 6.0 mL). TEOSYAL RHA Redensity: 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. It is supplied in individual treatment syringes with 30G ½ inch disposable sterile needles.	No Treatment No treatment control group.
Assessments of the Lip Function (Lip Movement) by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. Baseline - pre-injection	100.0 Proportion of words pronounced correctly Standard Deviation 0.0	—
Assessments of the Lip Function (Lip Movement) by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. Baseline - post-injection	87.0 Proportion of words pronounced correctly Standard Deviation 32.6	—
Assessments of the Lip Function (Lip Movement) by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. Week 2 - pre-injection	100.0 Proportion of words pronounced correctly Standard Deviation 0.0	—
Assessments of the Lip Function (Lip Movement) by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. Week 2 - post-injection	91.7 Proportion of words pronounced correctly Standard Deviation 27.2	—
Assessments of the Lip Function (Lip Movement) by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. Week 4	100.0 Proportion of words pronounced correctly Standard Deviation 0.0	—
Assessments of the Lip Function (Lip Movement) by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. Week 8	100.0 Proportion of words pronounced correctly Standard Deviation 0.0	—
Assessments of the Lip Function (Lip Movement) by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. Week 12	100.0 Proportion of words pronounced correctly Standard Deviation 0.0	—
Assessments of the Lip Function (Lip Movement) by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. Week 16	100.0 Proportion of words pronounced correctly Standard Deviation 0.0	—
Assessments of the Lip Function (Lip Movement) by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. Week 24	100.0 Proportion of words pronounced correctly Standard Deviation 0.0	—
Assessments of the Lip Function (Lip Movement) by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. Week 36	100.0 Proportion of words pronounced correctly Standard Deviation 0.0	—
Assessments of the Lip Function (Lip Movement) by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. Week 52	100.0 Proportion of words pronounced correctly Standard Deviation 0.0	—

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 24, 36, and 52 after the last treatment, (i.e., initial or touch-up treatment) and 4 weeks after a Repeat-Treatment.

Population: The following results reports data from subjects who received only the initial treatment (and if applicable, touch-up treatment) in order to confounding recovery with the effect of the new injection cycle(s).

Outcome measures

Outcome measures
Measure	TEOSYAL RHA Redensity n=200 Participants Injection of TEOSYAL RHA Redensity into the perioral lines. Up to 6.0 mL (max 3 mL for upper and max 3 mL for lower) injected into the dermis, including the superficial dermis. Touch-up treatment provided at 2 weeks (up to 6.0 mL). TEOSYAL RHA Redensity: 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. It is supplied in individual treatment syringes with 30G ½ inch disposable sterile needles.	No Treatment No treatment control group.
Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. Week 4	99.9 Proportion of touchpoints with sensation Standard Deviation 1.19	—
Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. Week 8	100.0 Proportion of touchpoints with sensation Standard Deviation 0.0	—
Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. Week 12	99.9 Proportion of touchpoints with sensation Standard Deviation 1.3	—
Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. Week 16	100.0 Proportion of touchpoints with sensation Standard Deviation 0.0	—
Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. Week 24	100.0 Proportion of touchpoints with sensation Standard Deviation 0.0	—
Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. Baseline - pre-injection	99.8 Proportion of touchpoints with sensation Standard Deviation 2.4	—
Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. Baseline - post-injection	80.3 Proportion of touchpoints with sensation Standard Deviation 36.0	—
Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. Week 2 - pre-injection	100.0 Proportion of touchpoints with sensation Standard Deviation 0.0	—
Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. Week 2 - post-injection	86.4 Proportion of touchpoints with sensation Standard Deviation 32.11	—
Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. Week 36	100.0 Proportion of touchpoints with sensation Standard Deviation 0.0	—
Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. Week 52	100.0 Proportion of touchpoints with sensation Standard Deviation 0.0	—

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 24, 36, and 52 after the last treatment, (i.e., initial or touch-up treatment) and 4 weeks after a Repeat-Treatment.

Outcome measures

Outcome measures
Measure	TEOSYAL RHA Redensity n=200 Participants Injection of TEOSYAL RHA Redensity into the perioral lines. Up to 6.0 mL (max 3 mL for upper and max 3 mL for lower) injected into the dermis, including the superficial dermis. Touch-up treatment provided at 2 weeks (up to 6.0 mL). TEOSYAL RHA Redensity: 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. It is supplied in individual treatment syringes with 30G ½ inch disposable sterile needles.	No Treatment No treatment control group.
Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. Baseline - pre-injection	99.9 Proportion of touchpoints with sensation Standard Deviation 1.2	—
Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. Baseline - post-injection	81.9 Proportion of touchpoints with sensation Standard Deviation 35.4	—
Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. Week 2 - pre-injection	100.0 Proportion of touchpoints with sensation Standard Deviation 0.0	—
Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. Week 12	99.9 Proportion of touchpoints with sensation Standard Deviation 1.25	—
Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. Week 16	100.0 Proportion of touchpoints with sensation Standard Deviation 0.0	—
Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. Week 24	100.0 Proportion of touchpoints with sensation Standard Deviation 0.0	—
Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. Week 36	100.0 Proportion of touchpoints with sensation Standard Deviation 0.0	—
Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. Week 52	100.0 Proportion of touchpoints with sensation Standard Deviation 0.0	—
Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. Week 2 - post-injection	86.7 Proportion of touchpoints with sensation Standard Deviation 31.9	—
Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. Week 4	99.9 Proportion of touchpoints with sensation Standard Deviation 1.19	—
Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. Week 8	100.0 Proportion of touchpoints with sensation Standard Deviation 0.0	—

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 24, 36, and 52 after the last treatment, (i.e., initial or touch-up treatment) and 4 weeks after a Repeat-Treatment.

Population: The following results reports data from subjects who received only the initial treatment (and if applicable, touch-up treatment), in order to confounding recovery with the effect of the new injection cycle(s).

Outcome measures

Outcome measures
Measure	TEOSYAL RHA Redensity n=200 Participants Injection of TEOSYAL RHA Redensity into the perioral lines. Up to 6.0 mL (max 3 mL for upper and max 3 mL for lower) injected into the dermis, including the superficial dermis. Touch-up treatment provided at 2 weeks (up to 6.0 mL). TEOSYAL RHA Redensity: 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. It is supplied in individual treatment syringes with 30G ½ inch disposable sterile needles.	No Treatment No treatment control group.
Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. Week 2 - pre-injection · Not able to use straw	0 Participants	—
Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. Week 2 - post-injection · Able to use straw	127 Participants	—
Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. Week 2 - post-injection · Not able to use straw	11 Participants	—
Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. Week 4 · Able to use straw	195 Participants	—
Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. Week 4 · Not able to use straw	0 Participants	—
Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. Week 8 · Able to use straw	197 Participants	—
Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. Week 8 · Not able to use straw	0 Participants	—
Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. Baseline - pre-injection · Able to use straw	199 Participants	—
Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. Baseline - pre-injection · Not able to use straw	0 Participants	—
Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. Baseline - post-injection · Able to use straw	176 Participants	—
Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. Baseline - post-injection · Not able to use straw	24 Participants	—
Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. Week 2 - pre-injection · Able to use straw	198 Participants	—
Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. Week 12 · Able to use straw	179 Participants	—
Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. Week 12 · Not able to use straw	0 Participants	—
Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. Week 16 · Able to use straw	180 Participants	—
Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. Week 16 · Not able to use straw	0 Participants	—
Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. Week 24 · Able to use straw	182 Participants	—
Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. Week 24 · Not able to use straw	0 Participants	—
Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. Week 36 · Able to use straw	173 Participants	—
Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. Week 36 · Not able to use straw	0 Participants	—
Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. Week 52 · Able to use straw	46 Participants	—
Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. Week 52 · Not able to use straw	0 Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Weeks 4 and 8 after last treatment

Population: The Intent-to-Treat Population was used for this analysis. For this outcome measure, missing data were imputed using a LOCF (Last Observation Carried Forward) method.

The PR-SRS is a validated 4-point static scale for assessing perioral rhytids severity. Possible scores range from 0 (Absent) to 3 (Severe). Change = (Week 4 - Baseline score) and (Week 8 - Baseline score). A PR-SRS change of 1-grade will be considered clinically significant. The No-Treatment control group after treatment was not pooled for this exploratory outcome measure.

Outcome measures

Outcome measures
Measure	TEOSYAL RHA Redensity n=150 Participants Injection of TEOSYAL RHA Redensity into the perioral lines. Up to 6.0 mL (max 3 mL for upper and max 3 mL for lower) injected into the dermis, including the superficial dermis. Touch-up treatment provided at 2 weeks (up to 6.0 mL). TEOSYAL RHA Redensity: 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. It is supplied in individual treatment syringes with 30G ½ inch disposable sterile needles.	No Treatment n=51 Participants No treatment control group.
Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Treating Investigator (TI) at Weeks 4 and 8 After Last Treatment. Week 4 · Responder	145 Participants	2 Participants
Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Treating Investigator (TI) at Weeks 4 and 8 After Last Treatment. Week 4 · Not Responder	5 Participants	49 Participants
Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Treating Investigator (TI) at Weeks 4 and 8 After Last Treatment. Week 4 · Missing values	0 Participants	0 Participants
Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Treating Investigator (TI) at Weeks 4 and 8 After Last Treatment. Week 8 · Responder	143 Participants	1 Participants
Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Treating Investigator (TI) at Weeks 4 and 8 After Last Treatment. Week 8 · Not Responder	7 Participants	50 Participants
Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Treating Investigator (TI) at Weeks 4 and 8 After Last Treatment. Week 8 · Missing values	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Weeks 4 and 8 after last treatment

Outcome measures

Outcome measures
Measure	TEOSYAL RHA Redensity n=150 Participants Injection of TEOSYAL RHA Redensity into the perioral lines. Up to 6.0 mL (max 3 mL for upper and max 3 mL for lower) injected into the dermis, including the superficial dermis. Touch-up treatment provided at 2 weeks (up to 6.0 mL). TEOSYAL RHA Redensity: 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. It is supplied in individual treatment syringes with 30G ½ inch disposable sterile needles.	No Treatment n=51 Participants No treatment control group.
Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the Treating Investigator (TI) at Weeks 4 and 8 After Last Treatment. Week 4 · No Improvement	1 Participants	48 Participants
Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the Treating Investigator (TI) at Weeks 4 and 8 After Last Treatment. Week 8 · Improved	145 Participants	2 Participants
Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the Treating Investigator (TI) at Weeks 4 and 8 After Last Treatment. Week 8 · No Improvement	2 Participants	47 Participants
Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the Treating Investigator (TI) at Weeks 4 and 8 After Last Treatment. Week 8 · Missing values	3 Participants	2 Participants
Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the Treating Investigator (TI) at Weeks 4 and 8 After Last Treatment. Week 4 · Improved	145 Participants	0 Participants
Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the Treating Investigator (TI) at Weeks 4 and 8 After Last Treatment. Week 4 · Missing values	4 Participants	3 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 8 after last treatment

Outcome measures

Outcome measures
Measure	TEOSYAL RHA Redensity n=150 Participants Injection of TEOSYAL RHA Redensity into the perioral lines. Up to 6.0 mL (max 3 mL for upper and max 3 mL for lower) injected into the dermis, including the superficial dermis. Touch-up treatment provided at 2 weeks (up to 6.0 mL). TEOSYAL RHA Redensity: 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. It is supplied in individual treatment syringes with 30G ½ inch disposable sterile needles.	No Treatment n=51 Participants No treatment control group.
Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Blinded Live Evaluator (BLE) at Week 8 After Last Treatment. < 1-grade improvement from Baseline	53 Participants	46 Participants
Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Blinded Live Evaluator (BLE) at Week 8 After Last Treatment. Missing values	4 Participants	3 Participants
Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Blinded Live Evaluator (BLE) at Week 8 After Last Treatment. > or = 1-grade improvement from Baseline	93 Participants	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Weeks 4 and 8 after last treatment

The Modified Glogau Classification Scale is a 4-point classification measuring wrinkle severity. Possible scores range from 1 (Mild) to 4 (Severe). A Glogau score change of 1-grade will be considered clinically significant. The No-Treatment control group after treatment was not pooled for this exploratory outcome measure. Change = (Week 4 - Baseline score) and (Week 8 - Baseline score)

Outcome measures

Outcome measures
Measure	TEOSYAL RHA Redensity n=150 Participants Injection of TEOSYAL RHA Redensity into the perioral lines. Up to 6.0 mL (max 3 mL for upper and max 3 mL for lower) injected into the dermis, including the superficial dermis. Touch-up treatment provided at 2 weeks (up to 6.0 mL). TEOSYAL RHA Redensity: 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. It is supplied in individual treatment syringes with 30G ½ inch disposable sterile needles.	No Treatment n=51 Participants No treatment control group.
Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Treating Investigator (TI) at Weeks 4 and 8 After Last Treatment. Week 4 · < 1-grade improvement from Baseline	41 Participants	46 Participants
Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Treating Investigator (TI) at Weeks 4 and 8 After Last Treatment. Week 4 · Missing values	4 Participants	3 Participants
Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Treating Investigator (TI) at Weeks 4 and 8 After Last Treatment. Week 4 · > or = 1-grade improvement from Baseline	105 Participants	2 Participants
Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Treating Investigator (TI) at Weeks 4 and 8 After Last Treatment. Week 8 · > or = 1-grade improvement from Baseline	106 Participants	4 Participants
Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Treating Investigator (TI) at Weeks 4 and 8 After Last Treatment. Week 8 · < 1-grade improvement from Baseline	41 Participants	45 Participants
Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Treating Investigator (TI) at Weeks 4 and 8 After Last Treatment. Week 8 · Missing values	3 Participants	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Weeks 8, 12, 16, 24, 36 and 52 after last treatment

Population: Of the randomized subjects (n=202), 2 subjects randomized to No-Treatment control did not receive treatment after the primary endpoint evaluation (Week 8 after randomization) and 1 subject randomized to No-Treatment control received treatment with study device, these 3 subjects are excluded from the pooled ITT population (n=199).

The PR-SRS is a validated 4-point static scale for assessing perioral rhytids severity. Possible scores range from 0 (Absent) to 3 (Severe). Change = (Week 8 - Baseline score), (Week 12 - Baseline score), (Week 16 - Baseline score), (Week 24 - Baseline score), (Week 36 - Baseline score), (Week 52 - Baseline score) A PR-SRS change of 1-grade will be considered clinically significant. The No-Treatment control group after treatment was pooled for this exploratory outcome measure.

Outcome measures

Outcome measures
Measure	TEOSYAL RHA Redensity n=199 Participants Injection of TEOSYAL RHA Redensity into the perioral lines. Up to 6.0 mL (max 3 mL for upper and max 3 mL for lower) injected into the dermis, including the superficial dermis. Touch-up treatment provided at 2 weeks (up to 6.0 mL). TEOSYAL RHA Redensity: 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. It is supplied in individual treatment syringes with 30G ½ inch disposable sterile needles.	No Treatment No treatment control group.
Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Blinded Live Evaluator (BLE) at Weeks 8, 12, 16, 24, 36 and 52 After Last Treatment. Week 12 · Responder	156 Participants	—
Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Blinded Live Evaluator (BLE) at Weeks 8, 12, 16, 24, 36 and 52 After Last Treatment. Week 12 · Not Responder	28 Participants	—
Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Blinded Live Evaluator (BLE) at Weeks 8, 12, 16, 24, 36 and 52 After Last Treatment. Week 36 · Not Responder	57 Participants	—
Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Blinded Live Evaluator (BLE) at Weeks 8, 12, 16, 24, 36 and 52 After Last Treatment. Week 52 · Responder	125 Participants	—
Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Blinded Live Evaluator (BLE) at Weeks 8, 12, 16, 24, 36 and 52 After Last Treatment. Week 52 · Not Responder	63 Participants	—
Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Blinded Live Evaluator (BLE) at Weeks 8, 12, 16, 24, 36 and 52 After Last Treatment. Week 8 · Responder	156 Participants	—
Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Blinded Live Evaluator (BLE) at Weeks 8, 12, 16, 24, 36 and 52 After Last Treatment. Week 8 · Not Responder	38 Participants	—
Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Blinded Live Evaluator (BLE) at Weeks 8, 12, 16, 24, 36 and 52 After Last Treatment. Week 16 · Responder	147 Participants	—
Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Blinded Live Evaluator (BLE) at Weeks 8, 12, 16, 24, 36 and 52 After Last Treatment. Week 16 · Not Responder	36 Participants	—
Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Blinded Live Evaluator (BLE) at Weeks 8, 12, 16, 24, 36 and 52 After Last Treatment. Week 24 · Responder	137 Participants	—
Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Blinded Live Evaluator (BLE) at Weeks 8, 12, 16, 24, 36 and 52 After Last Treatment. Week 24 · Not Responder	51 Participants	—
Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Blinded Live Evaluator (BLE) at Weeks 8, 12, 16, 24, 36 and 52 After Last Treatment. Week 36 · Responder	131 Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Weeks 4, 8, 12, 16, 24, 36 and 52 after last treatment

The PR-SRS is a validated 4-point static scale for assessing perioral rhytids severity. Possible scores range from 0 (Absent) to 3 (Severe). A PR-SRS change of 1-grade will be considered clinically significant. The No-Treatment control group after treatment was pooled for this exploratory outcome measure. Change = (Week 4 - Baseline score), (Week 8 - Baseline score), (Week 12 - Baseline score), (Week 16 - Baseline score), (Week 24 - Baseline score), (Week 36 - Baseline score), (Week 52 - Baseline score)

Outcome measures

Outcome measures
Measure	TEOSYAL RHA Redensity n=199 Participants Injection of TEOSYAL RHA Redensity into the perioral lines. Up to 6.0 mL (max 3 mL for upper and max 3 mL for lower) injected into the dermis, including the superficial dermis. Touch-up treatment provided at 2 weeks (up to 6.0 mL). TEOSYAL RHA Redensity: 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. It is supplied in individual treatment syringes with 30G ½ inch disposable sterile needles.	No Treatment No treatment control group.
Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36 and 52 After Last Treatment. Week 4 · Responder	187 Participants	—
Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36 and 52 After Last Treatment. Week 4 · Not Responder	7 Participants	—
Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36 and 52 After Last Treatment. Week 8 · Responder	186 Participants	—
Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36 and 52 After Last Treatment. Week 8 · Not Responder	10 Participants	—
Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36 and 52 After Last Treatment. Week 12 · Responder	175 Participants	—
Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36 and 52 After Last Treatment. Week 12 · Not Responder	9 Participants	—
Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36 and 52 After Last Treatment. Week 36 · Not Responder	27 Participants	—
Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36 and 52 After Last Treatment. Week 16 · Responder	171 Participants	—
Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36 and 52 After Last Treatment. Week 16 · Not Responder	12 Participants	—
Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36 and 52 After Last Treatment. Week 24 · Responder	173 Participants	—
Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36 and 52 After Last Treatment. Week 24 · Not Responder	17 Participants	—
Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36 and 52 After Last Treatment. Week 36 · Responder	161 Participants	—
Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36 and 52 After Last Treatment. Week 52 · Responder	149 Participants	—
Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36 and 52 After Last Treatment. Week 52 · Not Responder	39 Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Weeks 8, 12, 16, 24, 36 and 52 after last treatment

The PR-SRS is a validated 4-point static scale for assessing perioral rhytids severity. Possible scores range from 0 (Absent) to 3 (Severe). For a given subject to be considered a responder, at least 2 of the 3 readers must have confirmed a 1-point improvement for that subject The No-Treatment control group after treatment was pooled for this exploratory outcome measure. Change = (Week 8 - Baseline score), (Week 12 - Baseline score), (Week 16 - Baseline score), (Week 24 - Baseline score), (Week 36 - Baseline score), (Week 52 - Baseline score)

Outcome measures

Outcome measures
Measure	TEOSYAL RHA Redensity n=199 Participants Injection of TEOSYAL RHA Redensity into the perioral lines. Up to 6.0 mL (max 3 mL for upper and max 3 mL for lower) injected into the dermis, including the superficial dermis. Touch-up treatment provided at 2 weeks (up to 6.0 mL). TEOSYAL RHA Redensity: 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. It is supplied in individual treatment syringes with 30G ½ inch disposable sterile needles.	No Treatment No treatment control group.
Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by Independent Photographic Reviewers (IPR) at Weeks 8, 12, 16, 24, 36 and 52 After Last Treatment. Week 16 · Responder	85 Participants	—
Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by Independent Photographic Reviewers (IPR) at Weeks 8, 12, 16, 24, 36 and 52 After Last Treatment. Week 8 · Responder	106 Participants	—
Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by Independent Photographic Reviewers (IPR) at Weeks 8, 12, 16, 24, 36 and 52 After Last Treatment. Week 8 · Not Responder	90 Participants	—
Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by Independent Photographic Reviewers (IPR) at Weeks 8, 12, 16, 24, 36 and 52 After Last Treatment. Week 12 · Responder	94 Participants	—
Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by Independent Photographic Reviewers (IPR) at Weeks 8, 12, 16, 24, 36 and 52 After Last Treatment. Week 12 · Not Responder	89 Participants	—
Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by Independent Photographic Reviewers (IPR) at Weeks 8, 12, 16, 24, 36 and 52 After Last Treatment. Week 16 · Not Responder	92 Participants	—
Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by Independent Photographic Reviewers (IPR) at Weeks 8, 12, 16, 24, 36 and 52 After Last Treatment. Week 24 · Responder	92 Participants	—
Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by Independent Photographic Reviewers (IPR) at Weeks 8, 12, 16, 24, 36 and 52 After Last Treatment. Week 24 · Not Responder	96 Participants	—
Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by Independent Photographic Reviewers (IPR) at Weeks 8, 12, 16, 24, 36 and 52 After Last Treatment. Week 36 · Responder	89 Participants	—
Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by Independent Photographic Reviewers (IPR) at Weeks 8, 12, 16, 24, 36 and 52 After Last Treatment. Week 36 · Not Responder	97 Participants	—
Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by Independent Photographic Reviewers (IPR) at Weeks 8, 12, 16, 24, 36 and 52 After Last Treatment. Week 52 · Responder	93 Participants	—
Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by Independent Photographic Reviewers (IPR) at Weeks 8, 12, 16, 24, 36 and 52 After Last Treatment. Week 52 · Not Responder	95 Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Weeks 8, 12, 16, 24, 36 and 52 after last treatment

The Modified Glogau Classification Scale is a 4-point classification measuring wrinkle severity. Possible scores range from 1 (Mild) to 4 (Severe). A Glogau score change of 1-grade will be considered clinically significant. The No-Treatment control group after treatment was pooled for this exploratory outcome measure. Change = (Week 8 - Baseline score), (Week 12 - Baseline score), (Week 16 - Baseline score), (Week 24 - Baseline score), (Week 36 - Baseline score), (Week 52 - Baseline score)

Outcome measures

Outcome measures
Measure	TEOSYAL RHA Redensity n=199 Participants Injection of TEOSYAL RHA Redensity into the perioral lines. Up to 6.0 mL (max 3 mL for upper and max 3 mL for lower) injected into the dermis, including the superficial dermis. Touch-up treatment provided at 2 weeks (up to 6.0 mL). TEOSYAL RHA Redensity: 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. It is supplied in individual treatment syringes with 30G ½ inch disposable sterile needles.	No Treatment No treatment control group.
Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Blinded Live Evaluator (BLE) at Week 8, 12, 16, 24, 36 and 52 After Last Treatment. Week 8 · > or = 1-grade improvement from Baseline	117 Participants	—
Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Blinded Live Evaluator (BLE) at Week 8, 12, 16, 24, 36 and 52 After Last Treatment. Week 8 · < 1-grade improvement from Baseline	77 Participants	—
Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Blinded Live Evaluator (BLE) at Week 8, 12, 16, 24, 36 and 52 After Last Treatment. Week 12 · > or = 1-grade improvement from Baseline	116 Participants	—
Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Blinded Live Evaluator (BLE) at Week 8, 12, 16, 24, 36 and 52 After Last Treatment. Week 24 · > or = 1-grade improvement from Baseline	99 Participants	—
Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Blinded Live Evaluator (BLE) at Week 8, 12, 16, 24, 36 and 52 After Last Treatment. Week 12 · < 1-grade improvement from Baseline	68 Participants	—
Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Blinded Live Evaluator (BLE) at Week 8, 12, 16, 24, 36 and 52 After Last Treatment. Week 16 · > or = 1-grade improvement from Baseline	112 Participants	—
Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Blinded Live Evaluator (BLE) at Week 8, 12, 16, 24, 36 and 52 After Last Treatment. Week 16 · < 1-grade improvement from Baseline	71 Participants	—
Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Blinded Live Evaluator (BLE) at Week 8, 12, 16, 24, 36 and 52 After Last Treatment. Week 24 · < 1-grade improvement from Baseline	89 Participants	—
Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Blinded Live Evaluator (BLE) at Week 8, 12, 16, 24, 36 and 52 After Last Treatment. Week 36 · > or = 1-grade improvement from Baseline	93 Participants	—
Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Blinded Live Evaluator (BLE) at Week 8, 12, 16, 24, 36 and 52 After Last Treatment. Week 36 · < 1-grade improvement from Baseline	95 Participants	—
Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Blinded Live Evaluator (BLE) at Week 8, 12, 16, 24, 36 and 52 After Last Treatment. Week 52 · > or = 1-grade improvement from Baseline	89 Participants	—
Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Blinded Live Evaluator (BLE) at Week 8, 12, 16, 24, 36 and 52 After Last Treatment. Week 52 · < 1-grade improvement from Baseline	99 Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Weeks 4, 8, 12, 16, 24, 36 and 52 after last treatment

The Modified Glogau Classification Scale is a 4-point classification measuring wrinkle severity. Possible scores range from 1 (Mild) to 4 (Severe). A Glogau score change of 1-grade will be considered clinically significant. The No-Treatment control group after treatment was pooled for this exploratory outcome measure. Change = (Week 4 - Baseline score), (Week 8 - Baseline score), (Week 12 - Baseline score), (Week 16 - Baseline score), (Week 24 - Baseline score), (Week 36 - Baseline score), (Week 52 - Baseline score)

Outcome measures

Outcome measures
Measure	TEOSYAL RHA Redensity n=199 Participants Injection of TEOSYAL RHA Redensity into the perioral lines. Up to 6.0 mL (max 3 mL for upper and max 3 mL for lower) injected into the dermis, including the superficial dermis. Touch-up treatment provided at 2 weeks (up to 6.0 mL). TEOSYAL RHA Redensity: 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. It is supplied in individual treatment syringes with 30G ½ inch disposable sterile needles.	No Treatment No treatment control group.
Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. Week 24 · < 1-grade improvement from Baseline	75 Participants	—
Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. Week 36 · > or = 1-grade improvement from Baseline	106 Participants	—
Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. Week 52 · < 1-grade improvement from Baseline	103 Participants	—
Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. Week 36 · < 1-grade improvement from Baseline	82 Participants	—
Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. Week 52 · > or = 1-grade improvement from Baseline	85 Participants	—
Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. Week 4 · > or = 1-grade improvement from Baseline	135 Participants	—
Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. Week 4 · < 1-grade improvement from Baseline	59 Participants	—
Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. Week 8 · > or = 1-grade improvement from Baseline	134 Participants	—
Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. Week 8 · < 1-grade improvement from Baseline	62 Participants	—
Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. Week 12 · > or = 1-grade improvement from Baseline	129 Participants	—
Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. Week 12 · < 1-grade improvement from Baseline	55 Participants	—
Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. Week 16 · > or = 1-grade improvement from Baseline	117 Participants	—
Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. Week 16 · < 1-grade improvement from Baseline	66 Participants	—
Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. Week 24 · > or = 1-grade improvement from Baseline	115 Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Weeks 4, 8, 12, 16, 24, 36 and 52 after last treatment

The FACE-Q measures the experience and outcomes of aesthetic facial procedures from the patient's perspective. The FACE-Q questionnaire is composed of 6 questions with a score linked to answers (1 being 'Not at all' and 4 being 'Extremely'). To calculate the FACE-Q (Perioral Rhytids Domain) score, outcomes from all 6 questions were pooled, data were transformed so that higher scores reflected a superior (positive) outcome, and adapted to a scale of 100 units. The No-Treatment control group after treatment was pooled for this exploratory outcome measure.

Outcome measures

Outcome measures
Measure	TEOSYAL RHA Redensity n=199 Participants Injection of TEOSYAL RHA Redensity into the perioral lines. Up to 6.0 mL (max 3 mL for upper and max 3 mL for lower) injected into the dermis, including the superficial dermis. Touch-up treatment provided at 2 weeks (up to 6.0 mL). TEOSYAL RHA Redensity: 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. It is supplied in individual treatment syringes with 30G ½ inch disposable sterile needles.	No Treatment No treatment control group.
Subject's Perception of Treatment Effectiveness as Per the FACE-Q Scale (Perioral Rhytid Domain) Questionnaire at Week 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. Baseline Face-Q Score	22.8 score on a scale Standard Deviation 20.6	—
Subject's Perception of Treatment Effectiveness as Per the FACE-Q Scale (Perioral Rhytid Domain) Questionnaire at Week 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. Week 4 Face-Q Score	70.4 score on a scale Standard Deviation 22.8	—
Subject's Perception of Treatment Effectiveness as Per the FACE-Q Scale (Perioral Rhytid Domain) Questionnaire at Week 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. Face-Q Change from Baseline to Week 4	47.5 score on a scale Standard Deviation 26.9	—
Subject's Perception of Treatment Effectiveness as Per the FACE-Q Scale (Perioral Rhytid Domain) Questionnaire at Week 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. Week 8 Face-Q Score	69.3 score on a scale Standard Deviation 23.9	—
Subject's Perception of Treatment Effectiveness as Per the FACE-Q Scale (Perioral Rhytid Domain) Questionnaire at Week 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. Face-Q Change from Baseline to Week 8	46.5 score on a scale Standard Deviation 26.9	—
Subject's Perception of Treatment Effectiveness as Per the FACE-Q Scale (Perioral Rhytid Domain) Questionnaire at Week 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. Week 12	68.3 score on a scale Standard Deviation 23.3	—
Subject's Perception of Treatment Effectiveness as Per the FACE-Q Scale (Perioral Rhytid Domain) Questionnaire at Week 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. Face-Q Change from Baseline to Week 12	45.4 score on a scale Standard Deviation 26.4	—
Subject's Perception of Treatment Effectiveness as Per the FACE-Q Scale (Perioral Rhytid Domain) Questionnaire at Week 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. Week 16	66.8 score on a scale Standard Deviation 24.1	—
Subject's Perception of Treatment Effectiveness as Per the FACE-Q Scale (Perioral Rhytid Domain) Questionnaire at Week 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. Face-Q Change from Baseline to Week 16	43.4 score on a scale Standard Deviation 26.8	—
Subject's Perception of Treatment Effectiveness as Per the FACE-Q Scale (Perioral Rhytid Domain) Questionnaire at Week 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. Week 24	62.0 score on a scale Standard Deviation 26.1	—
Subject's Perception of Treatment Effectiveness as Per the FACE-Q Scale (Perioral Rhytid Domain) Questionnaire at Week 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. Face-Q Change from Baseline to Week 24	38.9 score on a scale Standard Deviation 29.3	—
Subject's Perception of Treatment Effectiveness as Per the FACE-Q Scale (Perioral Rhytid Domain) Questionnaire at Week 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. Week 36	62.1 score on a scale Standard Deviation 25.1	—
Subject's Perception of Treatment Effectiveness as Per the FACE-Q Scale (Perioral Rhytid Domain) Questionnaire at Week 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. Face-Q Change from Baseline to Week 36	38.8 score on a scale Standard Deviation 28.3	—
Subject's Perception of Treatment Effectiveness as Per the FACE-Q Scale (Perioral Rhytid Domain) Questionnaire at Week 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. Week 52	59.0 score on a scale Standard Deviation 24.1	—
Subject's Perception of Treatment Effectiveness as Per the FACE-Q Scale (Perioral Rhytid Domain) Questionnaire at Week 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. Face-Q Change from Baseline to Week 52	36.2 score on a scale Standard Deviation 26.2	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Weeks 4, 8, 12, 16, 24, 36 and 52 after last treatment

The Global Aesthetic Improvement (GAI) is a subjective, balanced, 5-point dynamic scale assessing cosmetic improvement. Possible scores range from "much improved", "improved", "no change", "worse", to "much worse". The GAI will be assessed using the baseline photograph. The No-Treatment control group after treatment was pooled for this exploratory outcome measure.

Outcome measures

Outcome measures
Measure	TEOSYAL RHA Redensity n=199 Participants Injection of TEOSYAL RHA Redensity into the perioral lines. Up to 6.0 mL (max 3 mL for upper and max 3 mL for lower) injected into the dermis, including the superficial dermis. Touch-up treatment provided at 2 weeks (up to 6.0 mL). TEOSYAL RHA Redensity: 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. It is supplied in individual treatment syringes with 30G ½ inch disposable sterile needles.	No Treatment No treatment control group.
Number of Subjects Who Scored Themselves Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. Week 4 · Improved	191 Participants	—
Number of Subjects Who Scored Themselves Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. Week 4 · No Improvement	3 Participants	—
Number of Subjects Who Scored Themselves Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. Week 8 · Improved	186 Participants	—
Number of Subjects Who Scored Themselves Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. Week 8 · No Improvement	10 Participants	—
Number of Subjects Who Scored Themselves Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. Week 12 · Improved	165 Participants	—
Number of Subjects Who Scored Themselves Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. Week 12 · No Improvement	19 Participants	—
Number of Subjects Who Scored Themselves Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. Week 16 · Improved	162 Participants	—
Number of Subjects Who Scored Themselves Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. Week 16 · No Improvement	20 Participants	—
Number of Subjects Who Scored Themselves Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. Week 24 · Improved	158 Participants	—
Number of Subjects Who Scored Themselves Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. Week 24 · No Improvement	32 Participants	—
Number of Subjects Who Scored Themselves Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. Week 36 · Improved	152 Participants	—
Number of Subjects Who Scored Themselves Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. Week 36 · No Improvement	36 Participants	—
Number of Subjects Who Scored Themselves Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. Week 52 · Improved	156 Participants	—
Number of Subjects Who Scored Themselves Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. Week 52 · No Improvement	32 Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Weeks 4, 8, 12, 16, 24, 36 and 52 after last treatment.

The Global Aesthetic Improvement (GAI) is a subjective, balanced, 5-point dynamic scale assessing cosmetic improvement. Possible scores range from "much improved", "improved", "no change", "worse", to "much worse". The GAI will be assessed using the baseline photograph. The No-Treatment control group after treatment was pooled for this exploratory outcome measure.

Outcome measures

Outcome measures
Measure	TEOSYAL RHA Redensity n=199 Participants Injection of TEOSYAL RHA Redensity into the perioral lines. Up to 6.0 mL (max 3 mL for upper and max 3 mL for lower) injected into the dermis, including the superficial dermis. Touch-up treatment provided at 2 weeks (up to 6.0 mL). TEOSYAL RHA Redensity: 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. It is supplied in individual treatment syringes with 30G ½ inch disposable sterile needles.	No Treatment No treatment control group.
Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. Week 24 · Improved	184 Participants	—
Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. Week 4 · Improved	192 Participants	—
Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. Week 4 · No Improvement	2 Participants	—
Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. Week 8 · Improved	193 Participants	—
Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. Week 8 · No Improvement	3 Participants	—
Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. Week 12 · Improved	181 Participants	—
Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. Week 12 · No Improvement	3 Participants	—
Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. Week 16 · Improved	181 Participants	—
Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. Week 16 · No Improvement	2 Participants	—
Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. Week 24 · No Improvement	6 Participants	—
Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. Week 36 · Improved	178 Participants	—
Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. Week 36 · No Improvement	10 Participants	—
Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. Week 52 · Improved	171 Participants	—
Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. Week 52 · No Improvement	17 Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Weeks 8, 12, 16, 24, 36 and 52 after last treatment

The Global Aesthetic Improvement (GAI) is a subjective, balanced, 5-point dynamic scale assessing cosmetic improvement. Possible scores range from "much improved", "improved", "no change", "worse", to "much worse". The GAI will be assessed using the baseline photograph. The No-Treatment control group after treatment was pooled for this exploratory outcome measure.

Outcome measures

Outcome measures
Measure	TEOSYAL RHA Redensity n=199 Participants Injection of TEOSYAL RHA Redensity into the perioral lines. Up to 6.0 mL (max 3 mL for upper and max 3 mL for lower) injected into the dermis, including the superficial dermis. Touch-up treatment provided at 2 weeks (up to 6.0 mL). TEOSYAL RHA Redensity: 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. It is supplied in individual treatment syringes with 30G ½ inch disposable sterile needles.	No Treatment No treatment control group.
Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE) at Weeks 8, 12, 16, 24, 36, 52 After Last Treatment. Week 8 · Improved	179 Participants	—
Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE) at Weeks 8, 12, 16, 24, 36, 52 After Last Treatment. Week 8 · No Improvement	15 Participants	—
Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE) at Weeks 8, 12, 16, 24, 36, 52 After Last Treatment. Week 12 · Improved	166 Participants	—
Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE) at Weeks 8, 12, 16, 24, 36, 52 After Last Treatment. Week 12 · No Improvement	18 Participants	—
Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE) at Weeks 8, 12, 16, 24, 36, 52 After Last Treatment. Week 16 · Improved	160 Participants	—
Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE) at Weeks 8, 12, 16, 24, 36, 52 After Last Treatment. Week 16 · No Improvement	23 Participants	—
Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE) at Weeks 8, 12, 16, 24, 36, 52 After Last Treatment. Week 24 · Improved	158 Participants	—
Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE) at Weeks 8, 12, 16, 24, 36, 52 After Last Treatment. Week 24 · No Improvement	30 Participants	—
Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE) at Weeks 8, 12, 16, 24, 36, 52 After Last Treatment. Week 36 · Improved	156 Participants	—
Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE) at Weeks 8, 12, 16, 24, 36, 52 After Last Treatment. Week 36 · No Improvement	32 Participants	—
Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE) at Weeks 8, 12, 16, 24, 36, 52 After Last Treatment. Week 52 · Improved	152 Participants	—
Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE) at Weeks 8, 12, 16, 24, 36, 52 After Last Treatment. Week 52 · No Improvement	36 Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Weeks 4, 8, 12, 16, 24, 36 and 52 after last treatment

Outcome measures

Outcome measures
Measure	TEOSYAL RHA Redensity n=199 Participants Injection of TEOSYAL RHA Redensity into the perioral lines. Up to 6.0 mL (max 3 mL for upper and max 3 mL for lower) injected into the dermis, including the superficial dermis. Touch-up treatment provided at 2 weeks (up to 6.0 mL). TEOSYAL RHA Redensity: 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. It is supplied in individual treatment syringes with 30G ½ inch disposable sterile needles.	No Treatment No treatment control group.
Number of Subjects "Satisfied" or "Very Satisfied" With Study Treatment Using the Subject Satisfaction Scale at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. Week 4 · Satisfied	178 Participants	—
Number of Subjects "Satisfied" or "Very Satisfied" With Study Treatment Using the Subject Satisfaction Scale at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. Week 4 · Not Satisfied	16 Participants	—
Number of Subjects "Satisfied" or "Very Satisfied" With Study Treatment Using the Subject Satisfaction Scale at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. Week 8 · Satisfied	178 Participants	—
Number of Subjects "Satisfied" or "Very Satisfied" With Study Treatment Using the Subject Satisfaction Scale at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. Week 8 · Not Satisfied	18 Participants	—
Number of Subjects "Satisfied" or "Very Satisfied" With Study Treatment Using the Subject Satisfaction Scale at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. Week 12 · Satisfied	166 Participants	—
Number of Subjects "Satisfied" or "Very Satisfied" With Study Treatment Using the Subject Satisfaction Scale at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. Week 12 · Not Satisfied	17 Participants	—
Number of Subjects "Satisfied" or "Very Satisfied" With Study Treatment Using the Subject Satisfaction Scale at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. Week 16 · Satisfied	163 Participants	—
Number of Subjects "Satisfied" or "Very Satisfied" With Study Treatment Using the Subject Satisfaction Scale at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. Week 16 · Not Satisfied	19 Participants	—
Number of Subjects "Satisfied" or "Very Satisfied" With Study Treatment Using the Subject Satisfaction Scale at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. Week 24 · Satisfied	159 Participants	—
Number of Subjects "Satisfied" or "Very Satisfied" With Study Treatment Using the Subject Satisfaction Scale at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. Week 24 · Not Satisfied	31 Participants	—
Number of Subjects "Satisfied" or "Very Satisfied" With Study Treatment Using the Subject Satisfaction Scale at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. Week 36 · Satisfied	164 Participants	—
Number of Subjects "Satisfied" or "Very Satisfied" With Study Treatment Using the Subject Satisfaction Scale at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. Week 36 · Not Satisfied	24 Participants	—
Number of Subjects "Satisfied" or "Very Satisfied" With Study Treatment Using the Subject Satisfaction Scale at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. Week 52 · Satisfied	166 Participants	—
Number of Subjects "Satisfied" or "Very Satisfied" With Study Treatment Using the Subject Satisfaction Scale at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. Week 52 · Not Satisfied	22 Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Weeks 8, 12, 16, 24, 36 and 52 after last treatment

The natural look and feel of the perioral area was assessed by subjects using an 11-point scale (ranging from 0 to 10). The No-Treatment control group after treatment was pooled for this exploratory outcome measure.

Outcome measures

Outcome measures
Measure	TEOSYAL RHA Redensity n=199 Participants Injection of TEOSYAL RHA Redensity into the perioral lines. Up to 6.0 mL (max 3 mL for upper and max 3 mL for lower) injected into the dermis, including the superficial dermis. Touch-up treatment provided at 2 weeks (up to 6.0 mL). TEOSYAL RHA Redensity: 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. It is supplied in individual treatment syringes with 30G ½ inch disposable sterile needles.	No Treatment No treatment control group.
Number of Subjects With a Natural Look and Feel ≥7 of the Perioral Area, at Week 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. Baseline : Natural Look and Feel score > and = 7	91 Participants	—
Number of Subjects With a Natural Look and Feel ≥7 of the Perioral Area, at Week 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. Week 4 : Natural Look and Feel score > and = 7	171 Participants	—
Number of Subjects With a Natural Look and Feel ≥7 of the Perioral Area, at Week 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. Week 8 : Natural Look and Feel score > and = 7	174 Participants	—
Number of Subjects With a Natural Look and Feel ≥7 of the Perioral Area, at Week 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. Week 12 : Natural Look and Feel score > and = 7	164 Participants	—
Number of Subjects With a Natural Look and Feel ≥7 of the Perioral Area, at Week 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. Week 16 : Natural Look and Feel score > and = 7	158 Participants	—
Number of Subjects With a Natural Look and Feel ≥7 of the Perioral Area, at Week 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. Week 24 : Natural Look and Feel score > and = 7	158 Participants	—
Number of Subjects With a Natural Look and Feel ≥7 of the Perioral Area, at Week 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. Week 36 : Natural Look and Feel score > and = 7	160 Participants	—
Number of Subjects With a Natural Look and Feel ≥7 of the Perioral Area, at Week 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. Week 52 : Natural Look and Feel score > and = 7	164 Participants	—

Adverse Events

SAFT Population After Initial Treatment - V1/V1B to V9

Serious events: 7 serious events

Other events: 120 other events

Deaths: 0 deaths

No Treatment - V1 to V4

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Treatment Group - V1 to V4

Serious events: 1 serious events

Other events: 74 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	SAFT Population After Initial Treatment - V1/V1B to V9 n=200 participants at risk The SAFT Population consisted of all subjects who were randomized and received at least one treatment with the study device during the course of the study (i.e. all subjects in the No-Treatment control group and all subjects in the TEOSYAL RHA® Redensity treatment group). Of the 202 randomized subjects, 2 subjects did not receive any treatment during the whole study, resulting in a SAFT population of n=200. For this pooled analysis, only AEs onset on or after initial study treatment are included : from V1/V1B to V9 (W52 or 56 weeks for patients receiving a re-treatment at W52). Therefore, for No-Treatment group, all AEs with onset date before initial treatment, i.e. V1b date, are excluded from this summary table.	No Treatment - V1 to V4 n=49 participants at risk No-Treatment group, before receiving initial treatment. For this pooled analysis, only AEs of subjects from the non-treatment group from V1(Baseline) to V4 (Week 8) are included.	Treatment Group - V1 to V4 n=151 participants at risk RHA Redensity group (Treatment group) from V1(Baseline) to V4 (Week 8) are included.
Reproductive system and breast disorders Breast Cancer	0.50% 1/200 • Number of events 1 • - 52 to 58 (for patients receiving re-treatment) weeks for subjects randomized to TEOSYAL RHA® Redensity group. - 60 to 66 (for patients receiving re-treatment) weeks for subjects randomized to No-Treatment control group.	0.00% 0/49 • - 52 to 58 (for patients receiving re-treatment) weeks for subjects randomized to TEOSYAL RHA® Redensity group. - 60 to 66 (for patients receiving re-treatment) weeks for subjects randomized to No-Treatment control group.	0.66% 1/151 • Number of events 1 • - 52 to 58 (for patients receiving re-treatment) weeks for subjects randomized to TEOSYAL RHA® Redensity group. - 60 to 66 (for patients receiving re-treatment) weeks for subjects randomized to No-Treatment control group.
Musculoskeletal and connective tissue disorders Osteoarthritis	1.0% 2/200 • Number of events 2 • - 52 to 58 (for patients receiving re-treatment) weeks for subjects randomized to TEOSYAL RHA® Redensity group. - 60 to 66 (for patients receiving re-treatment) weeks for subjects randomized to No-Treatment control group.	0.00% 0/49 • - 52 to 58 (for patients receiving re-treatment) weeks for subjects randomized to TEOSYAL RHA® Redensity group. - 60 to 66 (for patients receiving re-treatment) weeks for subjects randomized to No-Treatment control group.	0.00% 0/151 • - 52 to 58 (for patients receiving re-treatment) weeks for subjects randomized to TEOSYAL RHA® Redensity group. - 60 to 66 (for patients receiving re-treatment) weeks for subjects randomized to No-Treatment control group.
Cardiac disorders Palpitations	0.50% 1/200 • Number of events 1 • - 52 to 58 (for patients receiving re-treatment) weeks for subjects randomized to TEOSYAL RHA® Redensity group. - 60 to 66 (for patients receiving re-treatment) weeks for subjects randomized to No-Treatment control group.	0.00% 0/49 • - 52 to 58 (for patients receiving re-treatment) weeks for subjects randomized to TEOSYAL RHA® Redensity group. - 60 to 66 (for patients receiving re-treatment) weeks for subjects randomized to No-Treatment control group.	0.00% 0/151 • - 52 to 58 (for patients receiving re-treatment) weeks for subjects randomized to TEOSYAL RHA® Redensity group. - 60 to 66 (for patients receiving re-treatment) weeks for subjects randomized to No-Treatment control group.
Infections and infestations Pharyngeal Abscess	0.50% 1/200 • Number of events 1 • - 52 to 58 (for patients receiving re-treatment) weeks for subjects randomized to TEOSYAL RHA® Redensity group. - 60 to 66 (for patients receiving re-treatment) weeks for subjects randomized to No-Treatment control group.	0.00% 0/49 • - 52 to 58 (for patients receiving re-treatment) weeks for subjects randomized to TEOSYAL RHA® Redensity group. - 60 to 66 (for patients receiving re-treatment) weeks for subjects randomized to No-Treatment control group.	0.00% 0/151 • - 52 to 58 (for patients receiving re-treatment) weeks for subjects randomized to TEOSYAL RHA® Redensity group. - 60 to 66 (for patients receiving re-treatment) weeks for subjects randomized to No-Treatment control group.
Reproductive system and breast disorders Intraductal Proliferative Breast Lesion	0.50% 1/200 • Number of events 1 • - 52 to 58 (for patients receiving re-treatment) weeks for subjects randomized to TEOSYAL RHA® Redensity group. - 60 to 66 (for patients receiving re-treatment) weeks for subjects randomized to No-Treatment control group.	0.00% 0/49 • - 52 to 58 (for patients receiving re-treatment) weeks for subjects randomized to TEOSYAL RHA® Redensity group. - 60 to 66 (for patients receiving re-treatment) weeks for subjects randomized to No-Treatment control group.	0.00% 0/151 • - 52 to 58 (for patients receiving re-treatment) weeks for subjects randomized to TEOSYAL RHA® Redensity group. - 60 to 66 (for patients receiving re-treatment) weeks for subjects randomized to No-Treatment control group.
Reproductive system and breast disorders Fallopian Tube Cancer	0.50% 1/200 • Number of events 1 • - 52 to 58 (for patients receiving re-treatment) weeks for subjects randomized to TEOSYAL RHA® Redensity group. - 60 to 66 (for patients receiving re-treatment) weeks for subjects randomized to No-Treatment control group.	0.00% 0/49 • - 52 to 58 (for patients receiving re-treatment) weeks for subjects randomized to TEOSYAL RHA® Redensity group. - 60 to 66 (for patients receiving re-treatment) weeks for subjects randomized to No-Treatment control group.	0.00% 0/151 • - 52 to 58 (for patients receiving re-treatment) weeks for subjects randomized to TEOSYAL RHA® Redensity group. - 60 to 66 (for patients receiving re-treatment) weeks for subjects randomized to No-Treatment control group.

Other adverse events

Additional Information

Clinical Project Manager

Teoxane SA

Phone: +41(0) 22 344 96 36

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60