NCT04754646

RHA® 4 NLF Cannula

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Teoxane SA · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Accepted

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.

Conditions

• Wrinkle
• Nasolabial Fold
• Aging

Interventions

Type	Name	Description
DEVICE	Split-face injection of RHA® 4 with a cannula into a single NLF.	RHA® 4 is a sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus equi bacteria, formulated to a concentration of 23 mg/mL and 0.3% w/w lidocaine in a physiologic buffer. Up to 3.0 mL injected per NLF (mid-dermis to deep-dermis). Touch-up treatment provided at 2 weeks (up to 3.0 mL per NLF). The brand of cannula used for injection is up to the discretion of the Treating Investigator (TI), providing the cannula is registered for use by the US FDA.
DEVICE	Split-face injection of RHA® 4 with a needle (TSK 27G x ½") into the contralateral NLF.	RHA® 4 is a sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus equi bacteria, formulated to a concentration of 23 mg/mL and 0.3% w/w lidocaine in a physiologic buffer. Up to 3.0 mL injected per NLF (mid-dermis to deep-dermis). Touch-up treatment provided at 2 weeks (up to 3.0 mL per NLF).

Timeline

• Start date: 2021-03-15
• Primary completion: 2021-08-17
• Completion: 2021-11-29
• First posted: 2021-02-15
• Last updated: 2023-03-09
• Results posted: 2023-03-09

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study