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Dermal Filler

New Anesthetic Agent for Pain in Aesthetic Treatments

N/A
Waitlist Available
Research Sponsored by Teoxane SA
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Perioral rhytids of the same PR-SRS grade on the left and right sides of the mouth
Be older than 18 years old
Must not have
Female subjects who are pregnant, breast-feeding, or of childbearing potential and not practicing reliable birth control
Malignancy (excluding non-melanoma skin cancer) within the past 5 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up visit 1 - 15, 30, 45 and 60 minutes post-injection
Awards & highlights
No Placebo-Only Group

Summary

This trial is studying whether a new anesthetic agent in RHA® Redensity is as effective as lidocaine in reducing injection site pain during aesthetic treatments. Participants are evaluated for eligibility and given injections

Who is the study for?
This trial is for individuals with visible signs of aging around the mouth, assessed by a specific scale. Participants must be eligible based on their perioral rhytid severity and willing to receive injections on both sides of their mouth with different anesthetics.
What is being tested?
The study compares RHA® Redensity filler combined with a new anesthetic versus the same filler with lidocaine, focusing on pain during injection. It's randomized and double-blinded, meaning neither participants nor injectors know which treatment is given first or to which side of the mouth.
What are the potential side effects?
Potential side effects may include discomfort at the injection site, swelling, bruising, redness or itching. Any serious adverse events are monitored closely and followed up until resolved.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My wrinkles around the mouth are the same on both sides.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am pregnant, breastfeeding, or could become pregnant and am not using reliable birth control.
Select...
I have not had cancer (other than non-melanoma skin cancer) in the last 5 years.
Select...
I have had skin cancer in the area to be treated.
Select...
I do not have active infections or diseases in my mouth area.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~visit 1 - 15, 30, 45 and 60 minutes post-injection
This trial's timeline: 3 weeks for screening, Varies for treatment, and visit 1 - 15, 30, 45 and 60 minutes post-injection for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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.
Secondary study objectives
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.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: RHA® Redensity with new anesthetic agentExperimental Treatment1 Intervention
Split-face injection of RHA® Redensity with new anesthetic agent in the perioral rhytids on one side of the mouth and RHA® Redensity with lidocaine in the perioral rhytids in the other side of the mouth. Up to 3 mL injected per side.
Group II: RHA® Redensity with lidocaineExperimental Treatment1 Intervention
Split-face injection of RHA® Redensity with new anesthetic agent in the perioral rhytids on one side of the mouth and RHA® Redensity with lidocaine in the perioral rhytids in the other side of the mouth. Up to 3 mL injected per side.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RHA® Redensity with lidocaine
2019
N/A
~30
RHA® Redensity with new anesthetic agent
2019
N/A
~30

Find a Location

Who is running the clinical trial?

Teoxane SALead Sponsor
12 Previous Clinical Trials
1,459 Total Patients Enrolled
2 Trials studying Pain
60 Patients Enrolled for Pain
~7 spots leftby Feb 2025
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