RHA® 4 With New Anesthetic - Nasolabial Folds

NCT04087395 | Completed Results FDA Device

• 1 other identifier: TEO-RHA-1802
• 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® 4 with New Anesthetic Agent is non-inferior to RHA® 4 (with lidocaine) in terms of injection site pain felt by the subject during injection. At screening, the Treating Investigator (TI) evaluated subjects' NLF severity (using the Wrinkle Severity Rating Scale; WSRS) to confirm eligibility and to establish a pre-treatment score for assessing aesthetic improvement. At Visit 1, RHA® 4 With New Anesthetic Agent was administered in a random sequence (first or second injection) and side of the face (left or right) and RHA® 4 with lidocaine was administered to the other side. Study subjects and the TI injecting study devices were blinded. Immediately after injection of each side, subjects rated injection site pain experienced during injection using a 100 mm Visual Analog Scale (VAS). Injection site pain in each side of the face was also assessed at 15, 30, 45 and 60 minutes post-injection. 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 will be conducted. Subjects who present with an unresolved clinically significant device related AE at Visit 2 received the 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; Anesthetic; Lidocaine; Nasolabial Folds

Outcome Measures

Primary Outcomes (1)

• Non-inferiority of RHA® 4 With New Anesthetic Agent Versus RHA® 4-Lidocaine in Terms of Reducing Pain During Device Injection Into Nasolabial Folds.

  Injection pain during injection will be based on the 100 mm Visual Analog Scale (VAS), as assessed by subjects immediately after injection of each nasolabial fold. 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® 4 With New Anesthetic Agent Versus RHA® 4-Lidocaine in Term of Reducing Pain at 15, 30, 45 and 60 Minutes Post-injection in Nasolabial Folds of Each Side of the Face.

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

• Change in NLF WSRS Score Between Baseline and Day 30 as Assessed by the Treating Investigator

  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 Nasolabial Folds Wrinkle Severity Rating Scale (NLF-WSRS) 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 (Nasolabial Folds Domain) Questionnaire. The FACE-Q Measures the Experience and Outcomes of Aesthetic Facial Procedures From the Patient's Perspective.

  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 (just after receiving treatment) and Visit 2 (Day 30)

Study Arms (2)

RHA®4 with new anesthetic agent

EXPERIMENTAL

Split-face injection of RHA®4 with new anesthetic agent in the nasolabial fold of one side of the face and RHA®4-Lidocaine in the nasolabial fold of opposite side of the face. Up to 3 mL injected per side.

Device: RHA®4 with new anesthetic agent

RHA®4-Lidocaine

EXPERIMENTAL

Split-face injection of RHA®4 with new anesthetic agent in the nasolabial fold of one side of the face and RHA®4-Lidocaine in the nasolabial fold of opposite side of the face. Up to 3 mL injected per side.

Device: RHA®4-Lidocaine

Interventions

RHA®4 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 23 mg/g and 0.3% w/w of new anesthetic agent in a physiologic buffer.

RHA®4 with new anesthetic agent

RHA®4-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 23 mg/g and 0.3% w/w lidocaine in a physiologic buffer.

RHA®4-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 nasolabial folds (grade 3 or 4 on the five-point WSRS).
• Nasolabial folds of the same WSRS grade on the left and right sides of the face.
• 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.
• Use of a prohibited treatment/procedure within time periods defined in the protocol
• Known sensitivity to local anesthetics of the amide type, history of multiple severe allergies, or history of anaphylactic shock.
• History of active chronic debilitating systemic disease that, in the opinion of the investigator, would make the subject a poor candidate in the study.
• History of connective tissue disease.
• Malignancy (excluding non-melanoma skin cancer) within the past 5 years.
• History of skin cancer in the treatment area.
• Clinically active disease or infection in the NLF area.
• Medical or psychiatric conditions that may increase the risk associated with study participation or may interfere with the interpretation of study results or compliance of the subject and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study.
• Clinically significant alcohol or drug abuse, or history of poor cooperation or unreliability.
• Exposure to any other investigational drug/device within 90 days of entering the study.

Sponsors & Collaborators

• Teoxane SA: lead

Study Sites (3)

California

Beverly Hills, California, 90210, United States

Location

Florida

Coral Gables, Florida, 33146, United States

Location

Illinois

Chicago, Illinois, 60611, United States

Location

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: September 2, 2019
• First Posted: September 12, 2019
• Study Start: October 30, 2019
• Primary Completion: February 18, 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)