RHA® 3 Versus Restylane-L® for Lip Augmentation

NCT04540913 | Completed Results

• 1 other identifier: TEO-RHA-1806
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter, double-blinded, randomized, prospective, controlled clinical study to identify whether RHA® 3 is non-inferior to Restylane-L® for lip augmentation at Week 12 after the last treatment (initial or touch-up). At screening, the treating investigator (TI) will evaluate the subject's lip fullness using the validated Teoxane Lip Fullness Scale (5-grade) for eligibility of the subject for the study. At screening, the blinded live evaluator (BLE) will evaluate the subject's lip fullness using the TLFS to confirm eligibility and to establish a pre-treatment score for assessment of effectiveness. Enrolled subjects will be randomly assigned in a 3:1 ratio to either the RHA® 3 or the Restylane-L® treatment group. Subjects will be blinded to the study treatment. The TI will administer the fillers, and if necessary, subjects will receive a touch-up treatment 4 weeks after the initial treatment to optimize the results. If the touch-up treatment is administered, the subject will be asked to come to the site for an additional visit 4 weeks after the touch-up injection. The study duration was extended from 36 to 52 weeks once all subjects had already been enrolled. Nearly 60% of the subjects consented to extend the study to 52 weeks before being eligible for repeat treatment. All data are presented up to 52 weeks (as well as 4 more weeks follow-up after retreatment at 36 or 52 weeks). Subjects will be followed for 36 to 52 weeks after their last treatment (initial treatment or touch-up), at which point, they will be offered re-treatment with RHA® 3, regardless of their original treatment, provided that the TI deems the treatment to be appropriate and the subject agrees. Reasons for not administering the re-treatment will be documented. The subject will then be followed for an additional 4 weeks before exiting the study. If the subject or the TI declines re-treatment, this visit (36 or 52 weeks after the last treatment) will be considered the study Exit visit. For subjects with re-treatment, the Exit visit will be 4 weeks after the re-treatment. The TI will conduct safety and effectiveness evaluations at each study visit (up to 36 weeks or 52 (if applicable) weeks after the last treatment, and 4 weeks after re treatment) or until all treatment-related ongoing adverse events (AEs) have resolved or resolved with sequelae as per TI judgment or if follow-up is no longer possible.

Conditions

Lip Augmentation; Lip

Keywords

Dermal Filler; Hyaluronic acid; Lip; Lip Augmentation

Outcome Measures

Primary Outcomes (1)

• Change in TLFS Score (Teoxane Lip Fullness Scale) Between Baseline and Week 12 After Last Treatment of RHA®3 Versus Control Device, as Assessed by the BLE

  A change in the TLFS ≥1 grade compared to pre-treatment will be considered clinically meaningful. The TLFS is a validated 5-point scale for assessing lip augmentation. Possible scores range from 1 (Very Thin) to 5 (Very Full). Change = (Week 12 - Baseline score).

  Week 12 after last treatment

Secondary Outcomes (6)

• Change From Baseline in TLFS Score as Assessed by the BLE at Visit 5 (Weeks 24 After Last Treatment), 6 (Weeks 36 After Last Treatment), 7 (Week 52 After Last Treatment) if Applicable, and Re-treatment (4 Weeks After Re-treatment)

  Weeks 36 and 52 after last treatment, week 4 after re-treatment

• Responder Rate Calculated Using TLFS Assessed by the BLE

  Weeks 12, 36, 52 after last treatment, week 4 after re-treatment

• Number of Subjects "Satisfied" or "Very Satisfied" With Study Treatment Using the Subject Satisfaction Scale at Weeks 12, 36, 52 After Last Treatment and 4 Weeks After Re-treatment.

  Weeks 12, 36, 52 after last treatment and 4 week after re-treatment.

• Subject's Perception of Treatment Effectiveness as Per the "Satisfaction With Lips" FACE-Q | Aesthetics© Scale Questionnaire at Weeks 12, 36, 52 After Last Treatment and 4 Week After Re-treatment.

  Change from Baseline at Weeks 12, 36, 52 after last treatment and 4 week after re-treatment.

• Subject's Perception of Treatment Effectiveness as Per the "Satisfaction With Outcome" FACE-Q | Aesthetics© Scale Questionnaire at Weeks 12, 36, 52 After Last Treatment and 4 Week After Re-treatment.

  Weeks 12, 36, 52 after last treatment and 4 week after re-treatment.

Study Arms (2)

RHA 3

EXPERIMENTAL

Injection of RHA 3 into into the vermillion body, vermillion border, and oral commissures of the lips (up to 3 ml with a max of 1.5 ml per lip), injected into the lip mucosa and/or mid to deep dermis as appropriate for lip augmentation. Optional touch up treatment provided at 4 Weeks, optional retreatment at 36 or 52 Weeks.

Device: RHA 3

Restylane- L

ACTIVE COMPARATOR

Injection of Restylane- L into into the vermillion body, vermillion border, and oral commissures of the lips (up to 3 ml with a max of 1.5 ml per lip), injected into the lip mucosa and/or mid to deep dermis as appropriate for lip augmentation. Optional touch up treatment provided at 4 Weeks.

Device: Restylane-L

Interventions

RHA 3 DEVICE

Investigational Product, RHA® 3 is a viscoelastic, sterile, non-pyrogenic, clear, colorless, homogenous, and biodegradable gel implant. It is formulated with sodium hyaluronic acid (NaHA) at a concentration of 23 mg/g obtained from bacterial fermentation using the Streptococcus equi bacterial strained, crosslinked with 1,4 butanediol diglycidyl ether (BDDE) and reconstituted in a physiological buffer (pH 7.3). RHA® 3 also contains 0.3% lidocaine hydrochloride to reduce pain on injection.

RHA 3

Restylane-L DEVICE

Comparator Product, Restylane-L is a gel of hyaluronic acid generated by Streptococcus species of bacteria, chemically crosslinked with BDDE, stabilized and suspended in phosphate buffered saline at pH=7 and concentration of 20 mg/mL with 0.3% lidocaine.

Restylane- L

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
• Lip fullness of grade 1 to 3 on the TLFS (ranging from 1 to 5) who desire at least 1 point of correction for upper and/or lower lips OR has Fitzpatrick skin type V or VI and has lip fullness grade 4 or 5 on the TLFS who desire treatment to the vermillion body for upper and/or lower lips. The BLE and TI must independently assess and agree that this criterion is met; however, concordance of fullness is not required. If the assessments of the TI and the BLE are the same or differ by exactly 1 point on the scale, this difference is considered acceptable. If the assessments differ by 2 points or more on the scale, the subject will not be eligible.
• Willing to abstain from facial aesthetic procedures/therapies that could interfere with study evaluations
• Able to follow study instructions and complete all required visits.
• Sign the IRB-approved ICF, Photographic Release Form and the Authorization for Use and release of Health and Research Study Information (HIPAA) form prior to any study- related procedures being performed.

You may not qualify if:

• Female subjects that are pregnant, breast-feeding or of childbearing potential and not practicing reliable birth control
• Known hypersensitivity/allergy to any component of the study devices
• Clinically significant active skin disease within 6 months
• Has a history of or currently has an auto-immune disease.

Sponsors & Collaborators

• Teoxane SA: lead

Study Sites (1)

United States, Florida

Bradenton, Florida, 34209, United States

Location

MeSH Terms

Conditions

Lymphoid Interstitial Pneumonia

Results Point of Contact

• Title: Clinical Research Scientist
• 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
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2020
• First Posted: September 7, 2020
• Study Start: October 22, 2020
• Primary Completion: May 11, 2022
• Study Completion: September 7, 2022
• Last Updated: February 3, 2025
• Results First Posted: December 15, 2023

Record last verified: 2025-01

Locations

US (1)