RHA® Redensity With New Anesthetic Agent - Perioral Rhytids

NCT04069585 | Completed Results FDA Device

• 1 other identifier: TEO-RHA-1801
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief Summary

This is a randomized, controlled, double-blinded, within-subject (split-face), multicenter, prospective study to investigate whether RHA® Redensity with new anesthetic agent is non-inferior to RHA® Redensity with lidocaine in terms of injection site pain felt by the subject during injection. At screening, the Treating Investigator (TI) evaluated subjects' perioral rhytid severity (using the Perioral Rhytid Severity Rating Scale; PR-SRS) to confirm eligibility and to establish a pre-treatment score for assessing aesthetic improvement. At Visit 1, RHA® Redensity with new anesthetic agent was administered in a random sequence (first or second injection) and side of the mouth (left or right) and RHA® Redensity with lidocaine was administered to the other side. Study subjects and the TI injecting study devices were blinded. Immediately after injection of an upper perioral quadrant, subjects rated the injection site pain experienced during injection using a 100 mm Visual Analog Scale (VAS). Injection site pain in each side of the mouth was also assessed at 15, 30, 45 and 60 minutes after injection of the upper quadrant. Safety evaluation consisted of AE assessments, a 30-day CTR (Common Treatment Response) diary and a follow-up call performed by the study site at 72 hours after injection. Subjects attended Visit 2 (30 days post-injection) where efficacy and safety assessments were conducted. Subjects who presented with an unresolved clinically significant device related AE at Visit 2 received a optional follow-up phone call no later than 30 days after Visit 2. If the clinically significant AE remained unresolved, the Investigator requested that the subject attended the optional in-clinic follow-up visit (i.e., Visit 3) within 5 working days. Follow-up of the clinically significant AE continued until the AE was resolved or the TI determines that additional follow-up was not necessary.

Conditions

Aging; Pain

Keywords

Hyaluronic Acid; Perioral rhytids; Anesthetic; Lidocaine

Outcome Measures

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.

  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

  Visit 1 - During Injection

Secondary Outcomes (8)

• Difference Between RHA® Redensity With New Anesthetic Agent Versus RHA® Redensity With Lidocaine in Term of Reducing Pain at 15, 30, 45 and 60 Minutes Post-injection in Each Side of the Mouth.

  Visit 1 - 15, 30, 45 and 60 minutes post-injection

• Change From Baseline of PR-SRS Score for RHA® Redensity With New Anesthetic Agent Vs RHA® Redensity With Lidocaine for the Correction of Perioral Rhytids as Assessed by the Treating Investigator (TI)

  Visit 1 (Baseline, pre-injection) - Visit 1 (post-injection), Visit 2 (Day 30)

• Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade on the Perioral Rhytids Severity Rating Scale (PR-SRS) Compared to Baseline, as Assessed by the TI

  Visit 1 - Baseline (pre-injection), Visit 1 (post-injection), Visit 2 (Day 30)

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

  Visit 1 (Baseline) and Visit 2 (Day 30)

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

  Visit 1 (post-injection) and Visit 2 (Day 30)

Study Arms (2)

RHA® Redensity with new anesthetic agent

EXPERIMENTAL

Split-face injection of RHA® Redensity with new anesthetic agent in the perioral rhytids on one side of the mouth and RHA® Redensity with lidocaine in the perioral rhytids in the other side of the mouth. Up to 3 mL injected per side.

Device: RHA® Redensity with new anesthetic agent

RHA® Redensity with lidocaine

EXPERIMENTAL

Split-face injection of RHA® Redensity with lidocaine in the perioral rhytids on one side of the mouth and RHA® Redensity with new anesthetic agent in the perioral rhytids in the other side of the mouth. Up to 3 mL injected per side.

Device: RHA® Redensity with lidocaine

Interventions

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 new anesthetic agent

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.

RHA® Redensity with lidocaine

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Moderate to severe bilateral perioral rhytids (grade 2 or 3 on PR-SRS).
• 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.

You may not qualify if:

• 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).
• \. Exposure to any other investigational drug/device within 90 days of entering the study.
• \. Clinically significant alcohol or drug abuse, or history of poor cooperation or unreliability.

Sponsors & Collaborators

• Teoxane SA: lead

Study Sites (3)

California

Beverly Hills, California, 90120, United States

Location

Florida

Coral Gables, Florida, 33146, United States

Location

Chicago

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• Kaufman-Janette J, Joseph JH, Dayan SH, Smith S, Eaton L, Maffert P. Patient Comfort, Safety, and Effectiveness of Resilient Hyaluronic Acid Fillers Formulated With Different Local Anesthetics. Dermatol Surg. 2022 Oct 1;48(10):1065-1070. doi: 10.1097/DSS.0000000000003541. Epub 2022 Jul 13.

  PMID: 36129233 DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Clinical Project Manager
• Organization: TEOXANE SA

clinical@teoxane.com

+41(0) 22 344 96 36

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Split-face design

Study Record Dates

• First Submitted: August 23, 2019
• First Posted: August 28, 2019
• Study Start: October 30, 2019
• Primary Completion: February 24, 2020
• Study Completion: November 9, 2020
• Last Updated: January 24, 2022
• Results First Posted: June 16, 2021

Record last verified: 2021-05

Locations

US (3)