Clinical trial NCT04754646: RHA® 4 NLF Cannula
Official title: A Randomized, Controlled, Single-blinded, Within-subject (Split-face), Multicenter, Prospective Clinical Study to Evaluate the Effectiveness and Safety of Using the Dermal Filler RHA®4 Injected With a Cannula or With a Sharp Needle for the Treatment of Moderate to Severe Nasolabial Folds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wrinkle
Nasolabial Fold
Aging
Keywords: Dermal Filler
Hyaluronic acid
Cannula
Nasolabial folds
Lead sponsor: Teoxane SA
Sponsor class: INDUSTRY
First posted: 2021-02-15
Enrollment: 50
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 randomized, controlled, single-blinded, within-subject (split-face), multicenter, prospective study to investigate whether RHA®4 injected in NLFs with a cannula is non-inferior to RHA®4 injected in NLFs with a sharp needle (27G x ½") for the correction of moderate to severe NLFs as determined by the Blinded Live Evaluator (BLE) using the Teoxyne NLF-WSRS (proprietary, validated NLF Wrinkle Severity Rating Scale) at 12 weeks from last treatment.

At Visit 1 (Week 0), RHA®4 injected with cannula will be administered in a random sequence (first or second injection) and side of the face (left or right NLF) and RHA®4 injected with a sharp needle will be administered to the other side. The TI will administer study devices and will be unblinded to treatment allocation. Blinded assessments of effectiveness will be conducted by the BLE (Blinded Live Evaluator).

4 weeks following initial treatment, subjects will attend Visit 2 and receive, if necessary, touch-up treatments (using a needle or cannula as per the subject's initial treatment assignment).

Subjects receiving touch-up treatments at Week 4 (Visit 2) will attend a new Visit 2b (4 weeks following touch-up treatment); subject not receiving touch-up treatment will not attend Visit 2b.

After each injection (initial treatment or touch-up), subjects will receive a safety follow-up call from the study site within 3-day.

Subjects will then attend scheduled in-office study visits at 8 (Visit 3) and 12 weeks (Visit 4) following last treatment (initial treatment or touch-up) where safety and effectiveness assessments will be conducted.


Eligibility criteria: 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 and practice a reliable method of contraception throughout the study.
* Moderate to severe bilateral nasolabial folds (grade 3 or 4 on the five-point NLF-WSRS). BLE and TI must independently agree that the criterion is met; however, strict concordance of severity not required. BLE assessments will be used for the primary endpoint. If TI and BLE do not agree on eligibility, or if their assessments differ by ≥2 grades, the subject will not be eligible.
* Nasolabial folds of the same NLF-WSRS grade on the left and right sides of the face.
* Willing to abstain from facial aesthetic procedures/therapies that could interfere with the study evaluations.
* 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:

* 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.
* 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 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 or planning to participate in another investigation during the course of the study.
* Study staff or close relative to study staff (e.g., parents, children, siblings, or spouse)

Primary outcomes:
measure: Change in NLF-WSRS Score Between Baseline and Week 12 After Last Treatment as Assessed by the BLE
timeFrame: Week 12 after last treatment
Secondary outcomes:
measure: Change in Score From Baseline in the Nasolabial Folds Severity Rated by the Treating Investigator (TI) at Weeks 4, 8 and 12 After Last Treatment Using the NLF-WSRS.
timeFrame: Weeks 4, 8 and 12 after last treatment
measure: Number of Responders (Change of ≥1-grade From Baseline in the Naso-labial Folds Severity) as Assessed by the Blinded Live Evaluator (BLE) at Week 12 After Last Treatment Using the NLF-WSRS.
timeFrame: Week 12 after last treatment
measure: Number of Responders (Change of ≥1-grade From Baseline in the Naso-labial Folds Severity) as Assessed by the Treating Investigator (TI) at Weeks 4, 8 and 12 After Last Treatment Using the NLF-WSRS.
timeFrame: Weeks 4, 8 and 12 after last treatment
measure: Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE) at 12 Weeks Following Last Treatment.
timeFrame: Week 12 after last treatment
measure: Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the Treating Investigator (TI) at 4, 8 and 12 Weeks Following Last Treatment.
timeFrame: Weeks 4, 8 and 12 after last treatment
measure: Number of Subjects Who Scored Themselves Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale at 4, 8 and 12 Weeks Following Last Treatment.
timeFrame: Weeks 4, 8 and 12 after last treatment
measure: Number of Subjects "Satisfied" or "Very Satisfied" With Study Treatment Using the Subject Satisfaction Scale at 4, 8 and 12 Weeks Following Last Treatment.
timeFrame: Weeks 4, 8 and 12 after last treatment
measure: Subject's Perception of Treatment Effectiveness as Per the FACE-Q | Aesthetics© (Nasolabial Folds Domain) Questionnaire. The FACE-Q Measures the Experience and Outcomes of Aesthetic Facial Procedures From the Patient's Perspective.
timeFrame: Weeks 4, 8 and 12 after last treatment
measure: Number of Participants Receiving Initial and Touch-Up Treatment Sessions to Obtain an Optimal Cosmetic Results as Judged by the Treating Investigator
timeFrame: Baseline (Week 0, Visit 1) and Touch-up (Week 4, Visit 2)
measure: Total Volume Per NLF to Obtain an Optimal Cosmetic Results as Judged by the Treating Investigator.
timeFrame: Baseline (Week 0) and Touch-up (Week 4)
measure: NLF Symmetry as Assessed by the Blinded-live Evaluator at Baseline and 12 Weeks Following Last Treatment.
timeFrame: Baseline (Week 0) and Week 12 after last treatment
measure: NLF Symmetry as Assessed by the Treating Investigator at Baseline 4, 8 and 12 Weeks Following Last Treatment.
timeFrame: Weeks 4, 8 and 12 after last treatment
measure: NLF Symmetry as Assessed by the Subject at Baseline, 4, 8 and 12 Weeks Following Last Treatment.
timeFrame: Weeks 4, 8 and 12 after last treatment
measure: Number of Participants With Adverse Events (AEs) for the Safety Evaluation of RHA® 4
timeFrame: Baseline through Week 12 after last treatment
measure: Number of Post-Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for the Safety Evaluation of RHA® 4.
timeFrame: During 28 days after initial treatment and touch-up, so a total of 42 days post-baseline if the subject received a touch-up
measure: Assessment at Each Injection Visit (Initial Inejction and Touch-up) of Injection Site Pain Felt by the Patient for the Safety Evaluation of RHA® 4 Immediately After Treatment, and at 5, 30, and 60 Minutes Post-treatment
timeFrame: Immediately after treatment, and at 5, 30, and 60 minutes post-treatment
Other outcomes:
Locations:
city: Encinitas
country: United States
facility: United States, California
state: California
city: West Palm Beach
country: United States
facility: United States, Florida
state: Florida
city: Chapel Hill
country: United States
facility: United States, North Carolina
state: North Carolina
city: Nashville
country: United States
facility: United States, Tennessee
state: Tennessee
Study officials:
References: