Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06378086

RHA® Redensity With New Anesthetic Agent Perioral Rhytids (PAS)

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 Principal Investigator (PI) 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 PI 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 effectiveness 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Pain Aging Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Puerto Rico, San Juan

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Outpatient, male or female of any race, 22 years of age or older. Female subjects of childbearing potential must have a negative UPT at Visit 1 and practice a reliable method of contraception throughout the study.
  • Perioral rhytids of the same PR-SRS grade on the left and right sides of the mouth.
  • Able to follow study instructions and complete all required visits.
  • Sign the IRB-approved ICF, Photographic Release Form, the Authorization for Use and release of Health and Research Study Information (HIPAA) form, and if applicable the California Experimental Research Subject's Bill of Rights prior to any study-related procedures being performed.

Exclusion criteria

  • Female subjects who are pregnant, breast-feeding, or of childbearing potential and not practicing reliable birth control.
  • Known hypersensitivity or previous allergic reaction to any component of the study devices.
  • Known sensitivity to local anesthetics of the amide type, history of multiple severe allergies, or history of anaphylactic shock.
  • Clinically significant active skin disease or infection in the perioral area within 6 months prior to study entry (TI discretion).
  • History of active chronic debilitating systemic disease that, in the opinion of the investigator, would make the subject a poor candidate in the study.
  • Malignancy (excluding non-melanoma skin cancer) within the past 5 years.
  • History or presence of condition or feature that may confound the interpretation of the results in the perioral region, for example, tattoo, significant facial hair, acne scaring, prior surgery in the area, potential for active disease or infection flare up such as herpes simplex.
  • History of skin cancer in the treatment area.
  • Elective, clinically significant facial procedures that may confound the interpretation of the results in the perioral region (TI discretion), prior to study enrollment.
  • Clinically active disease or infection in the perioral area or mouth (e.g., dental abscess).
  • Clinically significant alcohol or drug abuse, or history of poor cooperation or unreliability.

Treatment and study plan

RHA® Redensity with new anesthetic agent

Device

A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus zooepidemicus, formulated to a concentration of 15 mg/g and 0.3% w/w of new anesthetic agent in a physiologic buffer.

RHA® Redensity with lidocaine

Device

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.

Primary outcomes

  1. Non-inferiority of RHA® Redensity with new anesthetic agent versus RHA® Redensity with lidocaine in terms of reducing pain during device injection into the upper perioral rhytids.

    Time frame: Visit 1 - During Injection

    Injection pain during injection was measured on the 100 mm Visual Analog Scale (VAS), as assessed by subjects immediately after injection of each upper perioral quadrant.

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

Secondary outcomes

  1. Difference between RHA® Redensity with new anesthetic agent versus RHA® Redensity with lidocaine in term of reducing pain at 15, 30, 45 and 60 minutes post-injection in each side of the mouth.

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Teoxane SA

Industry

Registry information

Official study title

A Randomized, Controlled, Double-blinded, Within-subject (Split-face), Multicenter, Prospective Clinical Study to Compare the Level of Pain Using the Dermal Filler RHA® Redensity Formulated With Two Different Anesthetics in the Treatment of Perioral Rhytids

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 22, 2024
Registry last updated
Apr 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.