Clinical trial NCT04540913: RHA® 3 Versus Restylane-L® for Lip Augmentation
Official title: A Controlled, Randomized, Double-blinded, Between-subject, Multicenter, Prospective Clinical Study to Evaluate Safety and Effectiveness of RHA® 3 Versus Restylane-L® for Lip Augmentation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Conditions: Lip Augmentation
Lip
Keywords: Dermal Filler
Hyaluronic acid
Lip
Lip Augmentation
Lead sponsor: Teoxane SA
Sponsor class: INDUSTRY
First posted: 2020-09-07
Enrollment: 202
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: 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
timeFrame: Week 12 after last treatment
Secondary outcomes:
measure: 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)
timeFrame: Weeks 36 and 52 after last treatment, week 4 after re-treatment
measure: Responder Rate Calculated Using TLFS Assessed by the BLE
timeFrame: Weeks 12, 36, 52 after last treatment, week 4 after re-treatment
measure: 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.
timeFrame: Weeks 12, 36, 52 after last treatment and 4 week after re-treatment.
measure: 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.
timeFrame: Change from Baseline at Weeks 12, 36, 52 after last treatment and 4 week after re-treatment.
measure: 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.
timeFrame: Weeks 12, 36, 52 after last treatment and 4 week after re-treatment.
measure: Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the BLE.
timeFrame: Weeks 12, 36, 52 after last treatment, and 4 weeks after re-treatment
Other outcomes:
Locations:
city: Bradenton
country: United States
facility: United States, Florida
state: Florida
Study officials:
References: