22 and older, any sex, with Aging or Pain. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Non-inferiority of RHA® Redensity With New Anesthetic Agent Versus RHA® Redensity With Lidocaine in Terms of Reducing Pain During Device Injection Into the Upper Perioral Rhytids.Primary· Visit 1 - During Injection
Injection pain during injection was measured on the 100 mm Visual Analog Scale (VAS), as assessed by subjects immediately after injection of each upper perioral quadrant.
VAS is a 100 mm Visual Analog Scale with 0 meaning no pain and 100 meaning intolerable pain
Group
Value
95% CI
RHA® Redensity With Lidocaine
22.4
± 23.21
RHA® Redensity With New Anesthetic Agent
25.0
± 25.63
Difference Between RHA® Redensity With New Anesthetic Agent Versus RHA® Redensity With Lidocaine in Term of Reducing Pain at 15, 30, 45 and 60 Minutes Post-injection in Each Side of the Mouth.Secondary· Visit 1 - 15, 30, 45 and 60 minutes post-injection
Injection pain was measured on the 100 mm Visual Analog Scale (VAS), as assessed by subjects in each side of the mouth.
VAS is a 100 mm Visual Analog Scale with 0 meaning no pain and 100 meaning intolerable pain
15 Min
Group
Value
95% CI
RHA® Redensity With Lidocaine
6.3
± 12.29
RHA® Redensity With New Anesthetic Agent
6.8
± 13.72
30 Min
Group
Value
95% CI
RHA® Redensity With Lidocaine
1.0
± 4.03
RHA® Redensity With New Anesthetic Agent
1.0
± 4.19
45 Min
Group
Value
95% CI
RHA® Redensity With Lidocaine
0.3
± 1.83
RHA® Redensity With New Anesthetic Agent
0.4
± 2.37
60 Min
Group
Value
95% CI
RHA® Redensity With Lidocaine
0.0
± 0.00
RHA® Redensity With New Anesthetic Agent
0.0
± 0.00
Change From Baseline of PR-SRS Score for RHA® Redensity With New Anesthetic Agent Vs RHA® Redensity With Lidocaine for the Correction of Perioral Rhytids as Assessed by the Treating Investigator (TI)Secondary· Visit 1 (Baseline, pre-injection) - Visit 1 (post-injection), Visit 2 (Day 30)
PR-SRS (Perioral Rhytids Severity Rating Scale) is a validated 4-grade scale with 0 being "Absent" and 3 being "Severe"
Visit 1 (Post-injection)
Group
Value
95% CI
RHA® Redensity With Lidocaine
-1.5
± 0.57
RHA® Redensity With New Anesthetic Agent
-1.5
± 0.63
Visit 2 (Day 30)
Group
Value
95% CI
RHA® Redensity With Lidocaine
-1.4
± 0.57
RHA® Redensity With New Anesthetic Agent
-1.4
± 0.56
Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade on the Perioral Rhytids Severity Rating Scale (PR-SRS) Compared to Baseline, as Assessed by the TISecondary· Visit 1 - Baseline (pre-injection), Visit 1 (post-injection), Visit 2 (Day 30)
A responder corresponds to a subject with an intra-individual improvement of at least one grade on the PR-SRS compared to Baseline
Visit 1 - post-injection
Group
Value
95% CI
RHA® Redensity With Lidocaine
29
RHA® Redensity With New Anesthetic Agent
28
RHA® Redensity With Lidocaine
1
RHA® Redensity With New Anesthetic Agent
2
Visit 2 - day 30
Group
Value
95% CI
RHA® Redensity With Lidocaine
29
RHA® Redensity With New Anesthetic Agent
29
RHA® Redensity With Lidocaine
1
RHA® Redensity With New Anesthetic Agent
1
Subject's Perception of Treatment Effectiveness as Per the FACE-Q (Perioral Rhytids Domain) Questionnaire.Secondary· Visit 1 (Baseline) and Visit 2 (Day 30)
The FACE-Q measures the experience and outcomes of aesthetic facial procedures from the patient's perspective.
FACE-Q questionnaire is composed of 6 questions with a score linked to answers (1 being 'Not at all' and 4 being 'Extremely').
The subject will be instructed as follows: ""These questions ask about how you look right now. For each question, circle only one answer. With the area around your lips in mind, in the past week, how much have you been bothered by:", and will provide response.
To calculate the FACE-Q, outcomes from all 6 questions were pooled, data were transformed so that
Baseline Face-Q Score
Group
Value
95% CI
RHA® Redensity With Lidocaine
13.0
± 19.07
RHA® Redensity With New Anesthetic Agent
12.5
± 18.99
Day 30 Face-Q Score
Group
Value
95% CI
RHA® Redensity With Lidocaine
73.9
± 28.84
RHA® Redensity With New Anesthetic Agent
77.2
± 25.78
Face-Q Change from Baseline to Day 30
Group
Value
95% CI
RHA® Redensity With Lidocaine
60.9
± 36.10
RHA® Redensity With New Anesthetic Agent
64.7
± 31.93
Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) by the Treating Investigator (TI)Secondary· Visit 1 (post-injection) and Visit 2 (Day 30)
Global Aesthetic Improvement (GAI) is a subjective 5-grade scale comprised of "much improved, improved, no change, worse, and much worse".
GAI will bewas assessed using the baseline photograph. Each side of the mouth were assessed independently.
Visit 1 (post-injection)
Group
Value
95% CI
RHA® Redensity With Lidocaine
30
RHA® Redensity With New Anesthetic Agent
30
Visit 2 (Day30)
Group
Value
95% CI
RHA® Redensity With Lidocaine
30
RHA® Redensity With New Anesthetic Agent
30
Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either "Much Improved" or "Improved") on GAI Scale According to Subject's Self-assessmentSecondary· Visit 1 (post-injection) and Visit 2 (Day 30)
Global Aesthetic Improvement (GAI) is a subjective 5-grade scale comprised of "much improved, improved, no change, worse, and much worse".
GAI was assessed using the baseline photograph. Subjects were instructed as follows: "Use a mirror to compare your face to the photograph provided to you and rate the degree of aesthetic improvement by using the following scale".
Each side of the face was assessed independently.
Visit 1 (post-injection)
Group
Value
95% CI
RHA® Redensity With Lidocaine
30
RHA® Redensity With New Anesthetic Agent
30
Visit 2 (Day 30)
Group
Value
95% CI
RHA® Redensity With Lidocaine
30
RHA® Redensity With New Anesthetic Agent
30
Number of Both "Satisfied" or "Very Satisfied" Subjects With Study Treatment Using the Subject's Satisfaction ScaleSecondary· Visit 1 (post-injection) and Visit 2 (Day 30)
The Subject Satisfaction Scale is a subjective, balanced, 5-point scale assessing subject satisfaction with study treatment. Possible scores range from with 1 (very satisfied) to 5 (very dissatisfied).
Proportion of subjects who were Satisfied (i.e., 1-Very Satisfied + 2-Satisfied) was compared to the proportion of subjects who were Not Satisfied (i.e., 3-Neither Satisfied nor dissatisfied + 4-Dissatisfied + 5-Very Dissatisfied)
Visit 1 (post-injection)
Group
Value
95% CI
RHA® Redensity With Lidocaine
29
RHA® Redensity With New Anesthetic Agent
29
RHA® Redensity With Lidocaine
1
RHA® Redensity With New Anesthetic Agent
1
Visit 2 (Day 30)
Group
Value
95% CI
RHA® Redensity With Lidocaine
29
RHA® Redensity With New Anesthetic Agent
29
RHA® Redensity With Lidocaine
1
RHA® Redensity With New Anesthetic Agent
1
Number of Subjects With Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of RHA® Redensity With New Anesthetic Agent Versus RHA® Redensity With LidocaineSecondary· During 30 days after injection
The subjects will receive a diary booklet and instructions for recording his/her observations of the Common Treatment Responses to the study treatments within 30 days following the treatment. The diary will be discussed during follow-up phone-call and visit. Subjects were instructed to complete the diary at approximately the same time each day (i.e., am or pm).
The subject diary captured the following Common Treatment Responses (CTR) that occur following the injection of a dermal filler; specifically, redness, pain, tenderness, firmness, swelling, lumps/bumps, bruising, itching, discoloration
Bruising
Group
Value
95% CI
RHA® Redensity With Lidocaine
16
RHA® Redensity With New Anesthetic Agent
12
Discoloration
Group
Value
95% CI
RHA® Redensity With Lidocaine
10
RHA® Redensity With New Anesthetic Agent
10
Firmness
Group
Value
95% CI
RHA® Redensity With Lidocaine
19
RHA® Redensity With New Anesthetic Agent
14
Itching
Group
Value
95% CI
RHA® Redensity With Lidocaine
2
RHA® Redensity With New Anesthetic Agent
4
Lumps/Bumps
Group
Value
95% CI
RHA® Redensity With Lidocaine
17
RHA® Redensity With New Anesthetic Agent
15
Pain
Group
Value
95% CI
RHA® Redensity With Lidocaine
4
RHA® Redensity With New Anesthetic Agent
3
Redness
Group
Value
95% CI
RHA® Redensity With Lidocaine
15
RHA® Redensity With New Anesthetic Agent
16
Swelling
Group
Value
95% CI
RHA® Redensity With Lidocaine
19
RHA® Redensity With New Anesthetic Agent
21
Adverse events — posted to ClinicalTrials.gov
Time frame: 1 month (33 days, overall study duration).
Reporting threshold: 3%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is a randomized, controlled, double-blinded, within-subject (split-face), multicenter, prospective study to investigate whether RHA® Redensity with new anesthetic agent is non-inferior to RHA® Redensity with lidocaine in terms of injection site pain felt by the subject during injection.
At screening, the Treating Investigator (TI) evaluated subjects' perioral rhytid severity (using the Perioral Rhytid Severity Rating Scale; PR-SRS) to confirm eligibility and to establish a pre-treatment score for assessing aesthetic improvement.
At Visit 1, RHA® Redensity with new anesthetic agent was administered in a random sequence (first or second injection) and side of the mouth (left or right) and RHA® Redensity with lidocaine was administered to the other side. Study subjects and the TI injecting study devices were blinded.
Immediately after injection of an upper perioral quadrant, subjects rated the injection site pain experienced during injection using a 100 mm Visual Analog Scale (VAS). Injection site pain in each side of the mouth was also assessed at 15, 30, 45 and 60 minutes after injection of the upper quadrant.
Safety evaluation consisted of AE assessments, a 30-day CTR (Common Treatment Response) diary and a follow-up call performed by the study site at 72 hours after injection.
Subjects attended Visit 2 (30 days post-injection) where efficacy and safety assessments were conducted.
Subjects who presented with an unresolved clinically significant device related AE at Visit 2 received a optional follow-up phone call no later than 30 days after Visit 2.
If the clinically significant AE remained unresolved, the Investigator requested that the subject attended the optional in-clinic follow-up visit (i.e., Visit 3) within 5 working days. Follow-up of the clinically significant AE continued until the AE was resolved or the TI determines that additional follow-up was not necessary.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Teoxane SA
Last refreshed: 24 January 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04069585.